Risedronate - A Medical Dictionary, Bibliography, and Annotated Research Guide to Internet References

RISEDRONATE A M EDICAL D ICTIONARY , B IBLIOGRAPHY , AND A NNOTATED R ESEARCH G UIDE TO I NTERNET R E FERENCES

J AMES N. P ARKER , M.D. AND P HILIP M. P ARKER , P H .D., E DITORS

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ICON Health Publications ICON Group International, Inc. 4370 La Jolla Village Drive, 4th Floor San Diego, CA 92122 USA Copyright 2004 by ICON Group International, Inc. Copyright 2004 by ICON Group International, Inc. All rights reserved. This book is protected by copyright. No part of it may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without written permission from the publisher. Printed in the United States of America. Last digit indicates print number: 10 9 8 7 6 4 5 3 2 1

Publisher, Health Care: Philip Parker, Ph.D. Editor(s): James Parker, M.D., Philip Parker, Ph.D. Publisher's note: The ideas, procedures, and suggestions contained in this book are not intended for the diagnosis or treatment of a health problem. As new medical or scientific information becomes available from academic and clinical research, recommended treatments and drug therapies may undergo changes. The authors, editors, and publisher have attempted to make the information in this book up to date and accurate in accord with accepted standards at the time of publication. The authors, editors, and publisher are not responsible for errors or omissions or for consequences from application of the book, and make no warranty, expressed or implied, in regard to the contents of this book. Any practice described in this book should be applied by the reader in accordance with professional standards of care used in regard to the unique circumstances that may apply in each situation. The reader is advised to always check product information (package inserts) for changes and new information regarding dosage and contraindications before prescribing any drug or pharmacological product. Caution is especially urged when using new or infrequently ordered drugs, herbal remedies, vitamins and supplements, alternative therapies, complementary therapies and medicines, and integrative medical treatments. Cataloging-in-Publication Data Parker, James N., 1961Parker, Philip M., 1960Risedronate: A Medical Dictionary, Bibliography, and Annotated Research Guide to Internet References / James N. Parker and Philip M. Parker, editors p. cm. Includes bibliographical references, glossary, and index. ISBN: 0-597-84611-1 1. Risedronate-Popular works. I. Title.

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Disclaimer This publication is not intended to be used for the diagnosis or treatment of a health problem. It is sold with the understanding that the publisher, editors, and authors are not engaging in the rendering of medical, psychological, financial, legal, or other professional services. References to any entity, product, service, or source of information that may be contained in this publication should not be considered an endorsement, either direct or implied, by the publisher, editors, or authors. ICON Group International, Inc., the editors, and the authors are not responsible for the content of any Web pages or publications referenced in this publication.

Copyright Notice If a physician wishes to copy limited passages from this book for patient use, this right is automatically granted without written permission from ICON Group International, Inc. (ICON Group). However, all of ICON Group publications have copyrights. With exception to the above, copying our publications in whole or in part, for whatever reason, is a violation of copyright laws and can lead to penalties and fines. Should you want to copy tables, graphs, or other materials, please contact us to request permission (E-mail: [email protected]). ICON Group often grants permission for very limited reproduction of our publications for internal use, press releases, and academic research. Such reproduction requires confirmed permission from ICON Group International, Inc. The disclaimer above must accompany all reproductions, in whole or in part, of this book.

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Acknowledgements The collective knowledge generated from academic and applied research summarized in various references has been critical in the creation of this book which is best viewed as a comprehensive compilation and collection of information prepared by various official agencies which produce publications on risedronate. Books in this series draw from various agencies and institutions associated with the United States Department of Health and Human Services, and in particular, the Office of the Secretary of Health and Human Services (OS), the Administration for Children and Families (ACF), the Administration on Aging (AOA), the Agency for Healthcare Research and Quality (AHRQ), the Agency for Toxic Substances and Disease Registry (ATSDR), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Healthcare Financing Administration (HCFA), the Health Resources and Services Administration (HRSA), the Indian Health Service (IHS), the institutions of the National Institutes of Health (NIH), the Program Support Center (PSC), and the Substance Abuse and Mental Health Services Administration (SAMHSA). In addition to these sources, information gathered from the National Library of Medicine, the United States Patent Office, the European Union, and their related organizations has been invaluable in the creation of this book. Some of the work represented was financially supported by the Research and Development Committee at INSEAD. This support is gratefully acknowledged. Finally, special thanks are owed to Tiffany Freeman for her excellent editorial support.

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About the Editors James N. Parker, M.D. Dr. James N. Parker received his Bachelor of Science degree in Psychobiology from the University of California, Riverside and his M.D. from the University of California, San Diego. In addition to authoring numerous research publications, he has lectured at various academic institutions. Dr. Parker is the medical editor for health books by ICON Health Publications. Philip M. Parker, Ph.D. Philip M. Parker is the Eli Lilly Chair Professor of Innovation, Business and Society at INSEAD (Fontainebleau, France and Singapore). Dr. Parker has also been Professor at the University of California, San Diego and has taught courses at Harvard University, the Hong Kong University of Science and Technology, the Massachusetts Institute of Technology, Stanford University, and UCLA. Dr. Parker is the associate editor for ICON Health Publications.

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About ICON Health Publications To discover more about ICON Health Publications, simply check with your preferred online booksellers, including Barnes&Noble.com and Amazon.com which currently carry all of our titles. Or, feel free to contact us directly for bulk purchases or institutional discounts: ICON Group International, Inc. 4370 La Jolla Village Drive, Fourth Floor San Diego, CA 92122 USA Fax: 858-546-4341 Web site: www.icongrouponline.com/health

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Table of Contents FORWARD .......................................................................................................................................... 1 CHAPTER 1. STUDIES ON RISEDRONATE ........................................................................................... 3 Overview........................................................................................................................................ 3 The Combined Health Information Database................................................................................. 3 Federally Funded Research on Risedronate.................................................................................... 5 The National Library of Medicine: PubMed .................................................................................. 8 CHAPTER 2. NUTRITION AND RISEDRONATE ................................................................................. 23 Overview...................................................................................................................................... 23 Finding Nutrition Studies on Risedronate .................................................................................. 23 Federal Resources on Nutrition ................................................................................................... 27 Additional Web Resources ........................................................................................................... 27 CHAPTER 3. CLINICAL TRIALS AND RISEDRONATE ........................................................................ 29 Overview...................................................................................................................................... 29 Recent Trials on Risedronate ....................................................................................................... 29 Keeping Current on Clinical Trials ............................................................................................. 30 CHAPTER 4. PATENTS ON RISEDRONATE ........................................................................................ 33 Overview...................................................................................................................................... 33 Patents on Risedronate ................................................................................................................ 33 Patent Applications on Risedronate............................................................................................. 35 Keeping Current .......................................................................................................................... 37 CHAPTER 5. PERIODICALS AND NEWS ON RISEDRONATE .............................................................. 39 Overview...................................................................................................................................... 39 News Services and Press Releases................................................................................................ 39 Newsletter Articles ...................................................................................................................... 42 Academic Periodicals covering Risedronate................................................................................. 43 CHAPTER 6. RESEARCHING MEDICATIONS .................................................................................... 45 Overview...................................................................................................................................... 45 U.S. Pharmacopeia....................................................................................................................... 45 Commercial Databases ................................................................................................................. 46 APPENDIX A. PHYSICIAN RESOURCES ............................................................................................ 49 Overview...................................................................................................................................... 49 NIH Guidelines............................................................................................................................ 49 NIH Databases............................................................................................................................. 51 Other Commercial Databases....................................................................................................... 53 APPENDIX B. PATIENT RESOURCES ................................................................................................. 55 Overview...................................................................................................................................... 55 Patient Guideline Sources............................................................................................................ 55 Finding Associations.................................................................................................................... 59 APPENDIX C. FINDING MEDICAL LIBRARIES .................................................................................. 61 Overview...................................................................................................................................... 61 Preparation................................................................................................................................... 61 Finding a Local Medical Library.................................................................................................. 61 Medical Libraries in the U.S. and Canada ................................................................................... 61 ONLINE GLOSSARIES.................................................................................................................. 67 Online Dictionary Directories ..................................................................................................... 67 RISEDRONATE DICTIONARY ................................................................................................... 69 INDEX ................................................................................................................................................ 91

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FORWARD In March 2001, the National Institutes of Health issued the following warning: "The number of Web sites offering health-related resources grows every day. Many sites provide valuable information, while others may have information that is unreliable or misleading."1 Furthermore, because of the rapid increase in Internet-based information, many hours can be wasted searching, selecting, and printing. Since only the smallest fraction of information dealing with risedronate is indexed in search engines, such as www.google.com or others, a non-systematic approach to Internet research can be not only time consuming, but also incomplete. This book was created for medical professionals, students, and members of the general public who want to know as much as possible about risedronate, using the most advanced research tools available and spending the least amount of time doing so. In addition to offering a structured and comprehensive bibliography, the pages that follow will tell you where and how to find reliable information covering virtually all topics related to risedronate, from the essentials to the most advanced areas of research. Public, academic, government, and peer-reviewed research studies are emphasized. Various abstracts are reproduced to give you some of the latest official information available to date on risedronate. Abundant guidance is given on how to obtain free-of-charge primary research results via the Internet. While this book focuses on the field of medicine, when some sources provide access to non-medical information relating to risedronate, these are noted in the text. E-book and electronic versions of this book are fully interactive with each of the Internet sites mentioned (clicking on a hyperlink automatically opens your browser to the site indicated). If you are using the hard copy version of this book, you can access a cited Web site by typing the provided Web address directly into your Internet browser. You may find it useful to refer to synonyms or related terms when accessing these Internet databases. NOTE: At the time of publication, the Web addresses were functional. However, some links may fail due to URL address changes, which is a common occurrence on the Internet. For readers unfamiliar with the Internet, detailed instructions are offered on how to access electronic resources. For readers unfamiliar with medical terminology, a comprehensive glossary is provided. For readers without access to Internet resources, a directory of medical libraries, that have or can locate references cited here, is given. We hope these resources will prove useful to the widest possible audience seeking information on risedronate. The Editors

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From the NIH, National Cancer Institute (NCI): http://www.cancer.gov/cancerinfo/ten-things-to-know.

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CHAPTER 1. STUDIES ON RISEDRONATE Overview In this chapter, we will show you how to locate peer-reviewed references and studies on risedronate.

The Combined Health Information Database The Combined Health Information Database summarizes studies across numerous federal agencies. To limit your investigation to research studies and risedronate, you will need to use the advanced search options. First, go to http://chid.nih.gov/index.html. From there, select the “Detailed Search” option (or go directly to that page with the following hyperlink: http://chid.nih.gov/detail/detail.html). The trick in extracting studies is found in the drop boxes at the bottom of the search page where “You may refine your search by.” Select the dates and language you prefer, and the format option “Journal Article.” At the top of the search form, select the number of records you would like to see (we recommend 100) and check the box to display “whole records.” We recommend that you type “risedronate” (or synonyms) into the “For these words:” box. Consider using the option “anywhere in record” to make your search as broad as possible. If you want to limit the search to only a particular field, such as the title of the journal, then select this option in the “Search in these fields” drop box. The following is what you can expect from this type of search: •

What the Gastroenterologist Should Know About the Gastrointestinal Safety Profiles of Bisphosphonates Source: Digestive Diseases and Sciences. 47(8): 1665-1678. August 2002. Contact: Available from Kluwer Academic Publishers. Customer Service Deparment, P.O. Box 358, Accord Station, Hingham, MA 02018-0358. (781) 871-6600. Fax (781) 6819045. E-mail: [email protected]. Website: www.wkap.nl. Distribution Centre, P.O. Box 322, 3300 AH Dordrecht, The Netherlands. 31 78 6392392. Fax: 31 78 6546474. E-mail: [email protected]. Summary: Biphosphonates are widely prescribed to treat Paget's disease of the bone and to prevent and treat osteoporosis. Soon after the release of alendronate, esophagitis and esophageal strictures were encountered, resulting in labeling changes for this drug. This

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article discusses gastrointestinal safety profiles of biphosphonates. Subsequent endoscopic studies in normal subjects showed that alendronate also caused gastric (stomach) erosions and ulcers. Although the clinical significance of these is still uncertain, the anatomic distribution of both the gastric ulcers and esophageal damage is consistent with a topical irritant effect. Recent data also suggest a synergistic ulcerogenic potential of concurrent alendronate and NSAID use. A 70 milligram once-weekly dosage form of alendronate has recently been approved and clinical experience with its gastrointestinal tolerability is ongoing. Risedronate, a third generation biphosphonate, appears to have less ulcerogenic potential than alendronate, and esophageal stricture has not been reported. Experience with the biphosphonates provides a paradigm for the critical role of endoscopists in evaluating the gastrointestinal profile of new drugs. 1 figure. 4 tables. 107 references. •

Bone up on Osteoporosis Source: Diabetes Forecast. 54(5): 62, 63. May 2001. Contact: Available from American Diabetes Association. 1701 North Beauregard Street, Alexandria, VA 22311. (800) 232-3472. Website: www.diabetes.org. Summary: This article reviews ways women with diabetes can reduce their risk of osteoporosis. This condition occurs when bone loss outpaces bone formation. Risk factors include being Caucasian or Asian, having a family history of the disease, consuming too much alcohol, being thin and small boned, smoking, eating a diet low in calcium, being postmenopausal, and having type 1 diabetes. Osteoporosis can be caused by eating disorders, lactose intolerance, physical inactivity, or a vitamin D deficiency. Osteoporosis can be treated and prevented when identified early. Dual energy x-ray absorptiometry (DEXA) is a painless test that can detect the presence and extent of bone loss. Options for preventing or reducing bone loss include undergoing drug treatment with estrogen, alendronate, and risedronate; consuming an adequate amount of calcium; and exercising.

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Paget's Diseases of Bone: A New Philosophy of Treatment Source: Patient Care. 33(20): 40-42,45-46,49-50,52,55,59-60. December 15, 1999. Summary: This journal article provides health professionals with information on the diagnosis of and treatment for Paget's disease of bone. This disease, which is the second most common metabolic bone disease after osteoporosis, most frequently affects white people older than 55. The sites most frequently affected are the pelvis, femur, spine, tibia, skull, and humerus. The disease is often first suspected after an elevated serum alkaline phosphatase level is found incidentally in an asymptomatic patient. Common symptoms include pain and sometimes increased warmth at the disease site. Laboratory tests and diagnostic imaging studies are tools used in diagnosing the disease. Markers of bone absorption such as urinary hydroxyproline or collagen crosslinks may be helpful in patients who have a normal alkaline phosphatase level but suggestive radiographic findings. Treatment for the disease has become more effective since the bisphosphonates became available. This class of drugs inhibits excessive bone remodeling activity. The location and activity of the disease determine whether treatment is necessary. Treatment is considered useful in almost all symptomatic patients, even if their symptoms are mild. Treatment is usually advised for asymptomatic patients who are in their early 40s or 50s; have active disease in the skull, spine, long bones, or areas near the major joints; have a markedly elevated alkaline phosphatase level; and have polyostotic disease. A drug from the bisphosphonate class such as etidronate, alendronate, tiludronate, risedronate,

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and pamidronate is usually considered first line treatment. The article describes the characteristics and side effects of these drugs and discusses the use of calcitonin-salmon, plicamycin, calcium, analgesics, and exercise to treat the disease. In addition, the article identifies complications and offers guidelines for referral and followup. 2 figures, 1 table, and 10 references.

Federally Funded Research on Risedronate The U.S. Government supports a variety of research studies relating to risedronate. These studies are tracked by the Office of Extramural Research at the National Institutes of Health.2 CRISP (Computerized Retrieval of Information on Scientific Projects) is a searchable database of federally funded biomedical research projects conducted at universities, hospitals, and other institutions. Search the CRISP Web site at http://crisp.cit.nih.gov/crisp/crisp_query.generate_screen. You will have the option to perform targeted searches by various criteria, including geography, date, and topics related to risedronate. For most of the studies, the agencies reporting into CRISP provide summaries or abstracts. As opposed to clinical trial research using patients, many federally funded studies use animals or simulated models to explore risedronate. The following is typical of the type of information found when searching the CRISP database for risedronate: •

Project Title: FT-IR OSTEOPOROSIS

MICROSCOPY

OF

MINERAL

STRUCTURE

IN

Principal Investigator & Institution: Boskey, Adele L.; Director, Mineralized Tissues Laboratory; Hospital for Special Surgery 535 E 70Th St New York, Ny 10021 Timing: Fiscal Year 2002; Project Start 01-JAN-1993; Project End 31-JUL-2005 Summary: (provided by applicant): Osteoporosis is estimated to affect 15-20 million people (both women and men) each year, causing significant morbidity and mortality. The widely used predictors of fracture risk are bone mineral density (BMD) and incidence of a previous fracture. One of the dilemmas in the management of osteoporosis is that two individuals with the same bone density and similar life-styles can show extensive diversity in their tendency to fracture. There is little information on what, other than differences in life style and fall severity, can account for this discrepancy. The underlying hypothesis of this grant is that discrete differences in mineral and matrix properties contribute to the altered fracture risk in these individuals. Over the past two funding periods, we have shown that Fourier transform infrared microspectroscopy (FTIRM) and imaging (FTIRI) provide reproducible and valuable information on the mineral and matrix properties of bone. We now wish to extend this approach to two new research questions: Aim 1) Do the mineral and matrix properties differ in biopsies from patients with fracture compared with patients without fractures while controlling for age, gender, bone mineral density, and architecture? This question will be tested by assessing biopsied specimens from individuals with different fracture histories and with known age, gender, and bone mineral density. MicroCT will be used 2

Healthcare projects are funded by the National Institutes of Health (NIH), Substance Abuse and Mental Health Services (SAMHSA), Health Resources and Services Administration (HRSA), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDCP), Agency for Healthcare Research and Quality (AHRQ), and Office of Assistant Secretary of Health (OASH).

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to assess architecture of the specimens, and FTIR will be used to characterize mineral and matrix properties. Under this specific aim, we will also examine associations between FTIR parameters and nanoindentation in a subset of biopsies to establish the nanoindentation technique and to test for significant correlations between mineral/matrix properties and indentation modulus and hardness. We will also develop the use of imaging ATR to establish an IR approach that does not required thin sections of embedded bone. Aim 2) Do therapeutic agents reverse the observed alterations in mineral and matrix properties? Specifically we shall examine the relative effects of a SERM (selective estrogen receptor modulator), raloxifene, Hormone Replacement Therapy, and a bisphosphonate (Risedronate) on the mineral and matrix properties in pre- and post- therapy biopsies, to identify the agent(s) that reverse(s) the observed alterations in mineral and matrix properties. Emphasis will be placed on those properties identified in Aim 1 that are most predictive of fracture. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen •

Project Title: PREVENTING BONE LOSS IN BLACK MEN WITH PROSTATE CANCER Principal Investigator & Institution: Nelson, Dorothy A.; Professor of Rheumatology; Internal Medicine; Wayne State University 656 W. Kirby Detroit, Mi 48202 Timing: Fiscal Year 2002; Project Start 25-SEP-2002; Project End 30-JUN-2004 Summary: (provided by applicant): It is well established that abrupt cessation of sex hormone production in men and women causes bone loss. Several studies have demonstrated that androgen deprivation therapy (ADT) in men with prostate cancer increases the risk of osteoporosis and fractures. As the age at diagnosis of prostate cancer decreases, the use of ADT increases, and life expectancy improves, more men will be living a substantial portion of their lives with sex hormone deficiency and a higher risk of osteoporotic fracture. We propose a planning grant for a future clinical trial that will compare the efficacy of intervention with bisphosphonate therapy (with calcium and vitamin D), versus calcium and vitamin D alone, in men with prostate cancer who are being treated with ADT. Specifically, we plan to study African-American men, who have been underrepresented in other such trials. We plan a 2-year, randomized, doubleblind trial of once-weekly oral bisphosphonate therapy plus daily calcium and vitamin D supplementation, compared with once-weekly placebo and daily calcium and vitamin D supplementation. Either alendronate or risedronate will be used for the bisphosphonate arm, to be determined during the planning phase. Bone density, biochemical markers of bone turnover, and body composition will be measured at regular intervals. Measures of free testosterone and gonadotropins will be obtained as part of routine clinical care. Fractures will be noted. The specific aims for the proposed planning grant include identification of additional clinical sites and clinical coinvestigators; refinement of the study design, including choice of bisphosphonate, sample size, and randomization scheme; development of a strategy to maximize recruitment and retention; preparation of a manual of procedures; and organization of a data safety monitoring committee. We believe that this planning period will allow us to develop specific elements essential to the success of the proposed trial without adding a lengthy organizational period to the actual trial. We also want to ensure that culturally sensitive, effective recruitment tools are in place. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen

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Project Title: SURVIVORS

PREVENTION

OF

OSTEOPOROSIS

IN

BREAST

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CANCER

Principal Investigator & Institution: Waltman, Nancy L.; Adult Health and Illness; University of Nebraska Medical Center Omaha, Ne 681987835 Timing: Fiscal Year 2002; Project Start 01-APR-2002; Project End 31-DEC-2006 Summary: Osteoporosis can be a major debilitating, expensive, long term, irreversible condition, and breast cancer survivors are particularly at risk for osteoporosis. As a result of some chemotherapy agents, many of these women experience premature ovarian failure. At least 60% of women with breast cancer have estrogen receptor positive tumor status; thus, they are not candidates for hormone replacement therapy. Without estrogen, bone loss occurs rapidly the first five years of menopause and continues over time but at a slower rate. The purpose of this study is to test whether strength/weight training exercises enhance the effectiveness of risedronate (5 mg/day), calcium (1200 mg/day), and vitamin D (400 IU/day) in improving bone mineral density (BMD) in post-menopausal breast cancer survivors. The sample will be 218 subjects recruited within a 100 mile radius of r sites across Nebraska (Omaha, Lincoln, Kearney and Scottsbluff). Post-menopausal women with a history of stage O (in situ), stage I or II breast cancer, with a BMD DEXA T-score of -1.0 SD or lower at any of 3 sites (hip, spine, forearm) will be stratified by time since menopause (5 yrs or less: > 5 years) and randomly assigned to one of two treatment groups (G1 and G2), with approximately 109 per group. Differences in tamoxifen, smoking, intake of calcium, and body mass index (BMI) between the two groups at baseline will be examined; if differences exist they will be controlled statistically. Both groups will receive risedronate, calcium and vitamin D; G1 also will receive strength/weight training exercises for upper and lower extremities and spine. Facilitative strategies based on Bandura's (1997) Self-Efficacy Theory are designed and used to encourage long-term adherence for both groups. The multicomponent intervention is 24 months with follow-up at 30 and 36 months. The primary outcome measure is BMD of the hip, spine and forearm (via DEXA): secondary outcome measures are muscle strength and fractures. The impact of the multi-component intervention on outcomes will be assessed using General Estimating Equation methodology Measurement of outcomes will occur at 6 and/or 12 month intervals through 36 months. In addition, relationships will be examined between level of confidence in goal accomplishment and adherence to intervention components over time. This study may provide evidence of an effective alternative to HRT for treatment of osteoporosis in breast cancer survivors who are not candidates for HRT. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen •

Project Title: RESTORATION OF LOST BONE MASS AFTER OVARIECTOMY Principal Investigator & Institution: Wronski, Thomas J.; Professor; Physiological Sciences; University of Florida Gainesville, Fl 32611 Timing: Fiscal Year 2002; Project Start 01-JUL-1991; Project End 31-JUL-2003 Summary: Recent findings in both human and animal studies indicate that the severely osteopenic skeleton fails to respond adequately to bone anabolic agents such as NaF and PTH, probably due to lack of adequate numbers of bone spicules that serve as a template for new bone formation. The proposed research will focus on preclinical testing of sequential treatment with bFGF and PTH to reverse severe cancellous osteopenia in aged, ovariectomized (OVX) rats. The initial treatment with bFGF will create new bone spicules within the bone marrow whereas subsequent PTH treatment will enlarge these spicules, improve trabecular microarchitecture, and enhance bone

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strength. In the first experiment, the optimal dose and minimum duration of treatment with bFGF for creation of new bone spicules within the marrow cavity will be determined. In the second experiment, aged OVX rats with severe tibial cancellous osteopenia will be subjected to short-term treatment with bFGF followed by a longer period of treatment with PTH. The third experiment will determine whether prior or concurrent treatment with anti-resorptive agents will affect the skeletal response to sequential treatment with bFGF and PTH. The skeletal effects of the various treatments will be studied in cancellous bone tissue of the severely osteopenic proximal tibial metaphysis and the moderately osteopenic lumbar vertebral body and femoral neck by standard bone histomorphometric and biomechanical techniques. It is hypothesized that 1) short-term treatment with bFGF followed by a longer period of treatment with PTH will restore lost cancellous bone completely at a skeletal site with severe osteopenia, and 2) prior or concurrent treatment with the anti-resorptive agents estrogen and risedronate will not blunt the skeletal response to sequential treatment with bFGF and PTH. This is an important issue to address since patients with severe osteopenia are likely to be treated with anti-resorptive agents prior to or during bone anabolic therapy. Validation of these hypotheses would provide support for a new therapeutic strategy for treatment of osteoporotic patients with severe osteopenia who respond poorly to conventional osteoporosis therapies. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen •

Project Title: RISEDRONATE POSTMENOPAUSE

TREATMENT

OF

OSTEOPOROSIS

IN

Principal Investigator & Institution: Lane, Nancy L.; University of California San Francisco 500 Parnassus Ave San Francisco, Ca 941222747 Timing: Fiscal Year 2002 Summary: This abstract is not available. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen

The National Library of Medicine: PubMed One of the quickest and most comprehensive ways to find academic studies in both English and other languages is to use PubMed, maintained by the National Library of Medicine.3 The advantage of PubMed over previously mentioned sources is that it covers a greater number of domestic and foreign references. It is also free to use. If the publisher has a Web site that offers full text of its journals, PubMed will provide links to that site, as well as to sites offering other related data. User registration, a subscription fee, or some other type of fee may be required to access the full text of articles in some journals. To generate your own bibliography of studies dealing with risedronate, simply go to the PubMed Web site at http://www.ncbi.nlm.nih.gov/pubmed. Type “risedronate” (or synonyms) into the search box, and click “Go.” The following is the type of output you can expect from PubMed for risedronate (hyperlinks lead to article summaries):

3 PubMed was developed by the National Center for Biotechnology Information (NCBI) at the National Library of Medicine (NLM) at the National Institutes of Health (NIH). The PubMed database was developed in conjunction with publishers of biomedical literature as a search tool for accessing literature citations and linking to full-text journal articles at Web sites of participating publishers. Publishers that participate in PubMed supply NLM with their citations electronically prior to or at the time of publication.

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14 day endoscopy study comparing risedronate and alendronate in postmenopausal women stratified by Helicobacter pylori status. Author(s): Thomson AB, Marshall JK, Hunt RH, Provenza JM, Lanza FL, Royer MG, Li Z, Blank MA; Risedronate Endoscopy Study Group. Source: The Journal of Rheumatology. 2002 September; 29(9): 1965-74. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=12233894

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A 2-year phase II study with 1-year of follow-up of risedronate (NE-58095) in postmenopausal osteoporosis. Author(s): Clemmesen B, Ravn P, Zegels B, Taquet AN, Christiansen C, Reginster JY. Source: Osteoporosis International : a Journal Established As Result of Cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the Usa. 1997; 7(5): 488-95. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=9425508

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A comparison of the effect of risedronate and etidronate on lumbar bone mineral density in Japanese patients with osteoporosis: a randomized controlled trial. Author(s): Fukunaga M, Kushida K, Kishimoto H, Shiraki M, Taketani Y, Minaguchi H, Inoue T, Morita R, Morii H, Yamamoto K, Ohashi Y, Orimo H; Risedronate Phase III Research Group. Source: Osteoporosis International : a Journal Established As Result of Cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the Usa. 2002 December; 13(12): 971-9. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=12459940

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A randomized, double-blind comparison of risedronate and etidronate in the treatment of Paget's disease of bone. Paget's Risedronate/Etidronate Study Group. Author(s): Miller PD, Brown JP, Siris ES, Hoseyni MS, Axelrod DW, Bekker PJ. Source: The American Journal of Medicine. 1999 May; 106(5): 513-20. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=10335722

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Acute changes in calcium homeostasis during treatment of primary hyperparathyroidism with risedronate. Author(s): Reasner CA, Stone MD, Hosking DJ, Ballah A, Mundy GR. Source: The Journal of Clinical Endocrinology and Metabolism. 1993 October; 77(4): 1067-71. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=8408454

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Alendronate and risedronate: what you need to know about their upper gastrointestinal tract toxicity. Author(s): Baker DE. Source: Reviews in Gastroenterological Disorders. 2002; 2(1): 20-33. Review. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=12122976

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An endoscopic comparison of the effects of alendronate and risedronate on upper gastrointestinal mucosae. Author(s): Lanza F, Schwartz H, Sahba B, Malaty HM, Musliner T, Reyes R, Quan H, Graham DY. Source: The American Journal of Gastroenterology. 2000 November; 95(11): 3112-7. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11095326

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Assessment of mortality in patients enrolled in a risedronate clinical trial program: a retrospective cohort study. Author(s): Steinbuch M, D'Agostino RB, Mandel JS, Gabrielson E, McClung MR, Stemhagen A, Hofman A. Source: Regulatory Toxicology and Pharmacology : Rtp. 2002 June; 35(3): 320-6. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=12202047

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Biologic, histologic and densitometric effects of oral risedronate on bone in patients with multiple myeloma. Author(s): Roux C, Ravaud P, Cohen-Solal M, de Vernejoul MC, Guillemant S, Cherruau B, Delmas P, Dougados M, Amor B. Source: Bone. 1994 January-February; 15(1): 41-9. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=8024850

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Bisphosphonate risedronate prevents bone loss in women with artificial menopause due to chemotherapy of breast cancer: a double-blind, placebo-controlled study. Author(s): Delmas PD, Balena R, Confravreux E, Hardouin C, Hardy P, Bremond A. Source: Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology. 1997 March; 15(3): 955-62. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=9060533

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Bisphosphonate risedronate reduces metastatic human breast cancer burden in bone in nude mice. Author(s): Sasaki A, Boyce BF, Story B, Wright KR, Chapman M, Boyce R, Mundy GR, Yoneda T. Source: Cancer Research. 1995 August 15; 55(16): 3551-7. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=7627963

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Bone density changes with once weekly risedronate in postmenopausal women. Author(s): Delaney MF, Hurwitz S, Shaw J, LeBoff MS. Source: Journal of Clinical Densitometry : the Official Journal of the International Society for Clinical Densitometry. 2003 Spring; 6(1): 45-50. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=12665701

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Changes in bone mineral density in patients with Paget's disease treated with risedronate. Author(s): Patel S, Pearson D, Bhallah A, Maslanka W, White DA, Hosking DJ. Source: Annals of the Rheumatic Diseases. 1997 July; 56(7): 405-9. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=9486001

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Comparison of change in bone resorption and bone mineral density with onceweekly alendronate and daily risedronate: a randomised, placebo-controlled study. Author(s): Hosking D, Adami S, Felsenberg D, Andia JC, Valimaki M, Benhamou L, Reginster JY, Yacik C, Rybak-Feglin A, Petruschke RA, Zaru L, Santora AC. Source: Current Medical Research and Opinion. 2003; 19(5): 383-94. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=13678475

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Direct stereological estimation of three-dimensional connectivity in rat vertebrae: effect of estrogen, etidronate and risedronate following ovariectomy. Author(s): Boyce RW, Wronski TJ, Ebert DC, Stevens ML, Paddock CL, Youngs TA, Gundersen HJ. Source: Bone. 1995 February; 16(2): 209-13. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=7756049

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Dose-proportional pharmacokinetics of risedronate on single-dose oral administration to healthy volunteers. Author(s): Mitchell DY, Eusebio RA, Sacco-Gibson NA, Pallone KA, Kelly SC, Nesbitt JD, Brezovic CP, Thompson GA, Powell JH. Source: Journal of Clinical Pharmacology. 2000 March; 40(3): 258-65. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=10709154

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Effect of combined risedronate and hormone replacement therapies on bone mineral density in postmenopausal women. Author(s): Harris ST, Eriksen EF, Davidson M, Ettinger MP, Moffett Jr AH Jr, Baylink DJ, Crusan CE, Chines AA. Source: The Journal of Clinical Endocrinology and Metabolism. 2001 May; 86(5): 1890-7. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11344179

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Effect of high doses of oral risedronate (20 mg/day) on serum parathyroid hormone levels and urinary collagen cross-link excretion in postmenopausal women with spinal osteoporosis. Author(s): Zegels B, Eastell R, Russell RG, Ethgen D, Roumagnac I, Collette J, Reginster JY. Source: Bone. 2001 January; 28(1): 108-12. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11165950

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Effect of renal function on risedronate pharmacokinetics after a single oral dose. Author(s): Mitchell DY, St Peter JV, Eusebio RA, Pallone KA, Kelly SC, Russell DA, Nesbitt JD, Thompson GA, Powell JH. Source: British Journal of Clinical Pharmacology. 2000 March; 49(3): 215-22. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=10718776

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Effect of risedronate on the risk of hip fracture in elderly women. Hip Intervention Program Study Group. Author(s): McClung MR, Geusens P, Miller PD, Zippel H, Bensen WG, Roux C, Adami S, Fogelman I, Diamond T, Eastell R, Meunier PJ, Reginster JY; Hip Intervention Program Study Group. Source: The New England Journal of Medicine. 2001 February 1; 344(5): 333-40. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11172164

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Effects of intermittent hPTH(1-34) alone and in combination with 1,25(OH)(2)D(3) or risedronate on endosteal bone remodeling in canine cancellous and cortical bone. Author(s): Boyce RW, Paddock CL, Franks AF, Jankowsky ML, Eriksen EF. Source: Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research. 1996 May; 11(5): 600-13. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=9157775

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Effects of long-term risedronate on bone quality and bone turnover in women with postmenopausal osteoporosis. Author(s): Eriksen EF, Melsen F, Sod E, Barton I, Chines A. Source: Bone. 2002 November; 31(5): 620-5. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=12477578

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Effects of prostaglandin E2 and risedronate administration on cancellous bone in older female rats. Author(s): Lin BY, Jee WS, Ma YF, Ke HZ, Kimmel DB, Li XJ. Source: Bone. 1994 September-October; 15(5): 489-96. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=7980959

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Effects of risedronate treatment on bone density and vertebral fracture in patients on corticosteroid therapy. Author(s): Wallach S, Cohen S, Reid DM, Hughes RA, Hosking DJ, Laan RF, Doherty SM, Maricic M, Rosen C, Brown J, Barton I, Chines AA. Source: Calcified Tissue International. 2000 October; 67(4): 277-85. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11000340

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Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. Vertebral Efficacy With Risedronate Therapy (VERT) Study Group. Author(s): Harris ST, Watts NB, Genant HK, McKeever CD, Hangartner T, Keller M, Chesnut CH 3rd, Brown J, Eriksen EF, Hoseyni MS, Axelrod DW, Miller PD. Source: Jama : the Journal of the American Medical Association. 1999 October 13; 282(14): 1344-52. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=10527181

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Efficacy and safety of daily risedronate in the treatment of corticosteroid-induced osteoporosis in men and women: a randomized trial. European CorticosteroidInduced Osteoporosis Treatment Study. Author(s): Reid DM, Hughes RA, Laan RF, Sacco-Gibson NA, Wenderoth DH, Adami S, Eusebio RA, Devogelaer JP. Source: Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research. 2000 June; 15(6): 1006-13. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=10841169

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Endoscopic comparison of esophageal and gastroduodenal effects of risedronate and alendronate in postmenopausal women. Author(s): Lanza FL, Hunt RH, Thomson AB, Provenza JM, Blank MA. Source: Gastroenterology. 2000 September; 119(3): 631-8. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=10982755

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Esophageal transit of risedronate cellulose-coated tablet and gelatin capsule formulations. Author(s): Perkins AC, Wilson CG, Frier M, Vincent RM, Blackshaw PE, Dansereau RJ, Juhlin KD, Bekker PJ, Spiller RC. Source: International Journal of Pharmaceutics. 1999 September 20; 186(2): 169-75. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=10486435

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Extra cancellous bone induced by combined prostaglandin E2 and risedronate administration is maintained after their withdrawal in older female rats. Author(s): Jee WS, Lin BY, Ma YF, Ke HZ. Source: Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research. 1995 June; 10(6): 963-70. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=7572321

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Histomorphometric effect of six month treatment with oral Risedronate in patients with multiple myeloma. Author(s): Cohen-Solal ME, Roux C, Valentin-Opran A, Dougados M, Amor B, De Vernejoul MC. Source: Bone. 1993 May-June; 14(3): 505-9. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=8363900

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Improvement of pagetic bone lesions with risedronate treatment: a radiologic study. Author(s): Brown JP, Chines AA, Myers WR, Eusebio RA, Ritter-Hrncirik C, Hayes CW. Source: Bone. 2000 March; 26(3): 263-7. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=10709999

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Intermittent on/off prostaglandin E2 and risedronate are equally anabolic as daily PGE2 alone treatment in cortical bone of ovariectomized rats. Author(s): Ma YF, Pan Z, Jee WS, Lin CH, Liang HH, Chen H, Pun S, Li XJ. Source: Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research. 1997 December; 12(12): 2108-12. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=9421244

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Long-term efficacy of risedronate: a 5-year placebo-controlled clinical experience. Author(s): Sorensen OH, Crawford GM, Mulder H, Hosking DJ, Gennari C, Mellstrom D, Pack S, Wenderoth D, Cooper C, Reginster JY. Source: Bone. 2003 February; 32(2): 120-6. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=12633783

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Meta-analyses of therapies for postmenopausal osteoporosis. III. Meta-analysis of risedronate for the treatment of postmenopausal osteoporosis. Author(s): Cranney A, Tugwell P, Adachi J, Weaver B, Zytaruk N, Papaioannou A, Robinson V, Shea B, Wells G, Guyatt G; Osteoporosis Methodology Group and The Osteoporosis Research Advisory Group. Source: Endocrine Reviews. 2002 August; 23(4): 517-23. Review. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=12202466

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Oesophageal transit, disintegration and gastric emptying of a film-coated risedronate placebo tablet in gastro-oesophageal reflux disease and normal control subjects. Author(s): Perkins AC, Wilson CG, Frier M, Blackshaw PE, Juan D, Dansereau RJ, Hathaway S, Li Z, Long P, Spiller RC. Source: Alimentary Pharmacology & Therapeutics. 2001 January; 15(1): 115-21. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11136284

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Paget's disease of bone: reduction of disease activity with oral risedronate. Author(s): Hosking DJ, Eusebio RA, Chines AA. Source: Bone. 1998 January; 22(1): 51-5. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=9437513

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Placebo-controlled, randomized, evaluator-blinded endoscopy study of risedronate vs. aspirin in healthy postmenopausal women. Author(s): Lanza FL, Rack MF, Li Z, Krajewski SA, Blank MA. Source: Alimentary Pharmacology & Therapeutics. 2000 December; 14(12): 1663-70. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11121916

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Prevention of bone loss with risedronate in glucocorticoid-treated rheumatoid arthritis patients. Author(s): Eastell R, Devogelaer JP, Peel NF, Chines AA, Bax DE, Sacco-Gibson N, Nagant de Deuxchaisnes C, Russell RG. Source: Osteoporosis International : a Journal Established As Result of Cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the Usa. 2000; 11(4): 331-7. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=10928223

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Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. Author(s): Reginster J, Minne HW, Sorensen OH, Hooper M, Roux C, Brandi ML, Lund B, Ethgen D, Pack S, Roumagnac I, Eastell R. Source: Osteoporosis International : a Journal Established As Result of Cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the Usa. 2000; 11(1): 83-91. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=10663363

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Re: Lanza et al.--Endoscopic comparison of alendronate and risedronate. Author(s): Blank MA, Thomson AB. Source: The American Journal of Gastroenterology. 2001 June; 96(6): 1938-40. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11419858

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Relationship of early changes in bone resorption to the reduction in fracture risk with risedronate. Author(s): Eastell R, Barton I, Hannon RA, Chines A, Garnero P, Delmas PD. Source: Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research. 2003 June; 18(6): 1051-6. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=12817758

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Response of bone mineral density to once-weekly administration of risedronate. Author(s): Gordon MS, Gordon MB. Source: Endocrine Practice : Official Journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists. 2002 May-June; 8(3): 202-7. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=12113633

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Review of risedronate in the treatment of osteoporosis. Author(s): Geusens P, McClung M. Source: Expert Opinion on Pharmacotherapy. 2001 December; 2(12): 2011-25. Review. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11825332

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Risedronate for the prevention and treatment of corticosteroid-induced osteoporosis. Author(s): Dougherty JA. Source: The Annals of Pharmacotherapy. 2002 March; 36(3): 512-6. Review. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11895066

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Risedronate for the prevention and treatment of postmenopausal osteoporosis: results from recent clinical trials. Author(s): Watts NB. Source: Osteoporosis International : a Journal Established As Result of Cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the Usa. 2001 December; 12 Suppl 3: S17-22. Review. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11846337

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Risedronate for the prevention of fractures in postmenopausal osteoporosis. Author(s): Sickels JM, Nip CS. Source: The Annals of Pharmacotherapy. 2002 April; 36(4): 664-70. Review. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11918518

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Risedronate gastrointestinal absorption is independent of site and rate of administration. Author(s): Mitchell DY, Eusebio RA, Dunlap LE, Pallone KA, Nesbitt JD, Russell DA, Clay ME, Bekker PJ. Source: Pharmaceutical Research. 1998 February; 15(2): 228-32. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=9523308

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Risedronate in Paget's disease: preliminary results of a multicenter study. Author(s): Brown JP, Kylstra JW, Bekker PJ, Axelrod DW, Siris ES, Altman RD, Singer FR. Source: Seminars in Arthritis and Rheumatism. 1994 February; 23(4): 272. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=8009253

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Risedronate in the treatment of Paget's disease of bone: an open label, multicenter study. Author(s): Siris ES, Chines AA, Altman RD, Brown JP, Johnston CC Jr, Lang R, McClung MR, Mallette LE, Miller PD, Ryan WG, Singer FR, Tucci JR, Eusebio RA, Bekker PJ. Source: Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research. 1998 June; 13(6): 1032-8. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=9626635

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Risedronate increases bone density and reduces vertebral fracture risk within one year in men on corticosteroid therapy. Author(s): Reid DM, Adami S, Devogelaer JP, Chines AA. Source: Calcified Tissue International. 2001 October; 69(4): 242-7. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11730260

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Risedronate increases bone mass in an early postmenopausal population: two years of treatment plus one year of follow-up. Author(s): Mortensen L, Charles P, Bekker PJ, Digennaro J, Johnston CC Jr. Source: The Journal of Clinical Endocrinology and Metabolism. 1998 February; 83(2): 396-402. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=9467547

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Risedronate increases bone mineral density and reduces the vertebral fracture incidence in postmenopausal women. Author(s): Reginster JY. Source: Clin Exp Rheumatol. 2001 March-April; 19(2): 121-2. No Abstract Available. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11326471

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Risedronate pharmacokinetics and intra- and inter-subject variability upon singledose intravenous and oral administration. Author(s): Mitchell DY, Barr WH, Eusebio RA, Stevens KA, Duke FP, Russell DA, Nesbitt JD, Powell JH, Thompson GA. Source: Pharmaceutical Research. 2001 February; 18(2): 166-70. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11405286

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Risedronate prevents hip fractures, but who should get therapy? Author(s): Deal CL. Source: Cleve Clin J Med. 2002 December; 69(12): 964, 968-70, 973-6. Review. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=12546269

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Risedronate prevents new vertebral fractures in postmenopausal women at high risk. Author(s): Watts NB, Josse RG, Hamdy RC, Hughes RA, Manhart MD, Barton I, Calligeros D, Felsenberg D. Source: The Journal of Clinical Endocrinology and Metabolism. 2003 February; 88(2): 542-9. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=12574177

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Risedronate reduces the risk of first vertebral fracture in osteoporotic women. Author(s): Heaney RP, Zizic TM, Fogelman I, Olszynski WP, Geusens P, Kasibhatla C, Alsayed N, Isaia G, Davie MW, Chesnut CH 3rd. Source: Osteoporosis International : a Journal Established As Result of Cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the Usa. 2002; 13(6): 501-5. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=12107665

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Risedronate reverses bone loss in postmenopausal women with low bone mass: results from a multinational, double-blind, placebo-controlled trial. BMD-MN Study Group. Author(s): Fogelman I, Ribot C, Smith R, Ethgen D, Sod E, Reginster JY. Source: The Journal of Clinical Endocrinology and Metabolism. 2000 May; 85(5): 1895900. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=10843171

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Risedronate therapy prevents corticosteroid-induced bone loss: a twelve-month, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Author(s): Cohen S, Levy RM, Keller M, Boling E, Emkey RD, Greenwald M, Zizic TM, Wallach S, Sewell KL, Lukert BP, Axelrod DW, Chines AA. Source: Arthritis and Rheumatism. 1999 November; 42(11): 2309-18. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=10555025

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Risedronate treatment and extended fracture protection in postmenopausal women. Author(s): Harris ST. Source: Clin Exp Rheumatol. 2001 November-December; 19(6): 625-6. No Abstract Available. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11791630

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Risedronate, a highly effective oral agent in the treatment of patients with severe Paget's disease. Author(s): Singer FR, Clemens TL, Eusebio RA, Bekker PJ. Source: The Journal of Clinical Endocrinology and Metabolism. 1998 June; 83(6): 1906-10. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=9626117

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Risedronate, a highly effective, short-term oral treatment for Paget's disease: a doseresponse study. Author(s): Brown JP, Hosking DJ, Ste-Marie L, Johnston CC Jr, Reginster J, Ryan WG, Johnson TD, Bekker PJ. Source: Calcified Tissue International. 1999 February; 64(2): 93-9. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=9914313

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Risedronate. Author(s): Goa KL, Balfour JA. Source: Drugs & Aging. 1998 July; 13(1): 83-91; Discussion 92. Review. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=9679211

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Risedronate: a clinical review. Author(s): Crandall C. Source: Archives of Internal Medicine. 2001 February 12; 161(3): 353-60. Review. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11176760

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Risedronate: a new bisphosphonate for the treatment of osteoporosis. Author(s): Kessenich CR. Source: The Nurse Practitioner. 2000 March; 25(3): 106-8. Review. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=10750124

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Risedronate: a new oral biophosphonate. Author(s): Roll KT. Source: Clinical Therapeutics. 2002 May; 24(5): 835-6. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=12075950

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Risedronate: a new oral bisphosphonate. Author(s): Umland EM, Boyce EG. Source: Clinical Therapeutics. 2001 September; 23(9): 1409-21. Review. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11589256

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Risedronate: a review of its pharmacological properties and clinical use in resorptive bone disease. Author(s): Dunn CJ, Goa KL. Source: Drugs. 2001; 61(5): 685-712. Review. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11368289

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Risedronate: clinical usage. Author(s): Chapurlat RD, Delmas PD. Source: Int J Clin Pract. 2001 May; 55(4): 275-8. Review. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11406915

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Role of alendronate and risedronate in preventing and treating osteoporosis. Author(s): Peters ML, Leonard M, Licata AA. Source: Cleve Clin J Med. 2001 November; 68(11): 945-51. Review. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11718433

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Short-term risedronate treatment in postmenopausal women: effects on biochemical markers of bone turnover. Author(s): Raisz L, Smith JA, Trahiotis M, Fall P, Shoukri K, Digennaro J, Sacco-Gibson N. Source: Osteoporosis International : a Journal Established As Result of Cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the Usa. 2000; 11(7): 615-20. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11069196

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Skeletal effects of constant and terminated use of sodium risedronate in ovariectomized rats. Author(s): Li QN, Liang NC, Huang LF, Wu T, Hu B, Mo LE. Source: Zhongguo Yao Li Xue Bao. 1998 March; 19(2): 160-3. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=10374643

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The effect of dosing regimen on the pharmacokinetics of risedronate. Author(s): Mitchell DY, Heise MA, Pallone KA, Clay ME, Nesbitt JD, Russell DA, Melson CW. Source: British Journal of Clinical Pharmacology. 1999 October; 48(4): 536-42. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=10583024

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The effect of risedronate on the risk of hip fracture in elderly women. Author(s): Schott AM, Dargent-Molina P, Meunier PJ. Source: The New England Journal of Medicine. 2001 May 31; 344(22): 1721. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11386284

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The effect of risedronate on the risk of hip fracture in elderly women. Author(s): Royce PC. Source: The New England Journal of Medicine. 2001 May 31; 344(22): 1720; Author Reply 1721. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11386283

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The effect of risedronate on the risk of hip fracture in elderly women. Author(s): Goodman RL. Source: The New England Journal of Medicine. 2001 May 31; 344(22): 1720-1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11386282

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The effects of risedronate on canine cancellous bone remodeling: three-dimensional kinetic reconstruction of the remodeling site. Author(s): Boyce RW, Paddock CL, Gleason JR, Sletsema WK, Eriksen EF. Source: Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research. 1995 February; 10(2): 211-21. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=7754801

Studies

21

•

The efficacy and tolerability of risedronate once a week for the treatment of postmenopausal osteoporosis. Author(s): Brown JP, Kendler DL, McClung MR, Emkey RD, Adachi JD, Bolognese MA, Li Z, Balske A, Lindsay R. Source: Calcified Tissue International. 2002 August; 71(2): 103-11. Epub 2002 June 27. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=12085156

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The in-vitro porcine adhesion model is not predictive of the esophageal transit of risedronate tablets in humans. Author(s): McCargar L, Crail D, Dansereau R, Myers W, Lane M. Source: International Journal of Pharmaceutics. 2001 July 17; 222(2): 191-7. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11427349

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The use of risedronate in Paget's disease. Author(s): Miller PD. Source: Bone. 1999 May; 24(5 Suppl): 91S-92S. Review. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=10321937

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The use of scintigraphy to demonstrate the rapid esophageal transit of the oval filmcoated placebo risedronate tablet compared to a round uncoated placebo tablet when administered with minimal volumes of water. Author(s): Perkins AC, Wilson CG, Frier M, Blackshaw PE, Dansereau RJ, Vincent RM, Wenderoth D, Hathaway S, Li Z, Spiller RC. Source: International Journal of Pharmaceutics. 2001 July 17; 222(2): 295-303. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11427359

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Tolerability of risedronate in postmenopausal women intolerant of alendronate. Author(s): Adachi JD, Adami S, Miller PD, Olszynski WP, Kendler DL, Silverman SL, Licata AA, Li Z, Gomez-Panzani E. Source: Aging (Milano). 2001 October; 13(5): 347-54. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11820707

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Upper gastrointestinal tract safety of risedronate: a pooled analysis of 9 clinical trials. Author(s): Taggart H, Bolognese MA, Lindsay R, Ettinger MP, Mulder H, Josse RG, Roberts A, Zippel H, Adami S, Ernst TF, Stevens KP. Source: Mayo Clinic Proceedings. 2002 March; 77(3): 262-70. Erratum In: Mayo Clin Proc 2002 June; 77(6): 601. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=11888030

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Use of matched historical controls to evaluate the anti-fracture efficacy of once-aweek risedronate. Author(s): Watts NB, Lindsay R, Li Z, Kasibhatla C, Brown J. Source: Osteoporosis International : a Journal Established As Result of Cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the Usa. 2003 June; 14(5): 437-41. Epub 2003 April 29. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=A bstract&list_uids=12730756

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CHAPTER 2. NUTRITION AND RISEDRONATE Overview In this chapter, we will show you how to find studies dedicated specifically to nutrition and risedronate.

Finding Nutrition Studies on Risedronate The National Institutes of Health’s Office of Dietary Supplements (ODS) offers a searchable bibliographic database called the IBIDS (International Bibliographic Information on Dietary Supplements; National Institutes of Health, Building 31, Room 1B29, 31 Center Drive, MSC 2086, Bethesda, Maryland 20892-2086, Tel: 301-435-2920, Fax: 301-480-1845, E-mail: [email protected]). The IBIDS contains over 460,000 scientific citations and summaries about dietary supplements and nutrition as well as references to published international, scientific literature on dietary supplements such as vitamins, minerals, and botanicals.4 The IBIDS includes references and citations to both human and animal research studies. As a service of the ODS, access to the IBIDS database is available free of charge at the following Web address: http://ods.od.nih.gov/databases/ibids.html. After entering the search area, you have three choices: (1) IBIDS Consumer Database, (2) Full IBIDS Database, or (3) Peer Reviewed Citations Only. Now that you have selected a database, click on the “Advanced” tab. An advanced search allows you to retrieve up to 100 fully explained references in a comprehensive format. Type “risedronate” (or synonyms) into the search box, and click “Go.” To narrow the search, you can also select the “Title” field.

4

Adapted from http://ods.od.nih.gov. IBIDS is produced by the Office of Dietary Supplements (ODS) at the National Institutes of Health to assist the public, healthcare providers, educators, and researchers in locating credible, scientific information on dietary supplements. IBIDS was developed and will be maintained through an interagency partnership with the Food and Nutrition Information Center of the National Agricultural Library, U.S. Department of Agriculture.

24

Risedronate

The following information is typical of that found when using the “Full IBIDS Database” to search for “risedronate” (or a synonym): •

A 2-year phase II study with 1-year of follow-up of risedronate (NE-58095) in postmenopausal osteoporosis. Author(s): Center for Clinical and Basic Research, Ballerup, Denmark. Source: Clemmesen, B Ravn, P Zegels, B Taquet, A N Christiansen, C Reginster, J Y Osteoporos-Int. 1997; 7(5): 488-95 0937-941X

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A comparison of the effect of risedronate and etidronate on lumbar bone mineral density in Japanese patients with osteoporosis: a randomized controlled trial. Author(s): Department of Nuclear Medicine, Kawasaki Medical School, Okayama, Japan. Source: Fukunaga, M Kushida, K Kishimoto, H Shiraki, M Taketani, Y Minaguchi, H Inoue, T Morita, R Morii, H Yamamoto, K Ohashi, Y Orimo, H Osteoporos-Int. 2002 December; 13(12): 971-9 0937-941X

•

Acute changes in calcium homeostasis during treatment of primary hyperparathyroidism with risedronate. Author(s): Department of Medicine, University of Texas Health Science Center, San Antonio 78284-7877. Source: Reasner, C A Stone, M D Hosking, D J Ballah, A Mundy, G R J-Clin-EndocrinolMetab. 1993 October; 77(4): 1067-71 0021-972X

•

Co-treatment of PGE2 and risedronate is better than PGE2 alone in the long-term treatment of ovariectomized-induced osteopenic rats. Author(s): Radiobiology Division, University of Utah, Salt Lake City 84112, USA. Source: Ma, Y Chen, Y Y Jee, W S Ke, H Z Ijiri, K Bone. 1995 October; 17(4 Suppl): 267S272S 8756-3282

•

Direct stereological estimation of three-dimensional connectivity in rat vertebrae: effect of estrogen, etidronate and risedronate following ovariectomy. Author(s): Procter and Gamble Pharmaceuticals, Norwich, NY, USA. Source: Boyce, R W Wronski, T J Ebert, D C Stevens, M L Paddock, C L Youngs, T A Gundersen, H J Bone. 1995 February; 16(2): 209-13 8756-3282

•

Effect of high doses of oral risedronate (20 mg/day) on serum parathyroid hormone levels and urinary collagen cross-link excretion in postmenopausal women with spinal osteoporosis. Author(s): Bone and Cartilage Metabolism Unit, University of Liege, Liege, Belgium. Source: Zegels, B Eastell, R Russell, R G Ethgen, D Roumagnac, I Collette, J Reginster, J Y Bone. 2001 January; 28(1): 108-12 8756-3282

•

Effects of intermittent hPTH(1-34) alone and in combination with 1,25(OH)(2)D(3) or risedronate on endosteal bone remodeling in canine cancellous and cortical bone. Author(s): Procter and Gamble Pharmaceuticals, Norwich, New York, USA. Source: Boyce, R W Paddock, C L Franks, A F Jankowsky, M L Eriksen, E F J-BoneMiner-Res. 1996 May; 11(5): 600-13 0884-0431

•

Effects of prostaglandin E2 and risedronate administration on cancellous bone in older female rats. Author(s): Division of Radiobiology, University of Utah School of Medicine, Salt Lake City 84112. Source: Lin, B Y Jee, W S Ma, Y F Ke, H Z Kimmel, D B Li, X J Bone. 1994 Sep-October; 15(5): 489-96 8756-3282

Nutrition 25

•

Effects of risedronate treatment on bone density and vertebral fracture in patients on corticosteroid therapy. Author(s): Hospital for Joint Diseases, New York, New York, USA. Source: Wallach, S Cohen, S Reid, D M Hughes, R A Hosking, D J Laan, R F Doherty, S M Maricic, M Rosen, C Brown, J Barton, I Chines, A A Calcif-Tissue-Int. 2000 October; 67(4): 277-85 0171-967X

•

Efficacy and safety of daily risedronate in the treatment of corticosteroid-induced osteoporosis in men and women: a randomized trial. European CorticosteroidInduced Osteoporosis Treatment Study. Author(s): Department of Medicine and Therapeutics, University of Aberdeen, Foresterhill, United Kingdom. Source: Reid, D M Hughes, R A Laan, R F Sacco Gibson, N A Wenderoth, D H Adami, S Eusebio, R A Devogelaer, J P J-Bone-Miner-Res. 2000 June; 15(6): 1006-13 0884-0431

•

Extra cancellous bone induced by combined prostaglandin E2 and risedronate administration is maintained after their withdrawal in older female rats. Author(s): Division of Radiobiology, University of Utah School of Medicine, Salt Lake City, USA. Source: Jee, W S Lin, B Y Ma, Y F Ke, H Z J-Bone-Miner-Res. 1995 June; 10(6): 963-70 0884-0431

•

Intermittent on/off prostaglandin E2 and risedronate are equally anabolic as daily PGE2 alone treatment in cortical bone of ovariectomized rats. Author(s): Radiobiology Division, University of Utah School of Medicine, Salt Lake City 84112, USA. Source: Ma, Y F Pan, Z Jee, W S Lin, C H Liang, H H Chen, H Pun, S Li, X J J-BoneMiner-Res. 1997 December; 12(12): 2108-12 0884-0431

•

Intermittent treatment of prostaglandin E2 with risedronate is more anabolic than prostaglandin E2 alone in the proximal tibial metaphysis of ovariectomized rats. Author(s): Radiobiology Division, University of Utah, Salt Lake City 84112, USA. Source: Chen, H K Jee, W S Ma, Y F Pan, Z McOsker, J E Li, X J Bone. 1995 October; 17(4 Suppl): 285S-289S 8756-3282

•

Prevention of bone loss in ovariectomized rats by combined treatment with risedronate and 1alpha,25-dihydroxyvitamin D3. Author(s): Institute of Physiology, Physiological Chemistry, and Animal Nutrition, Ludwig Maximilians University, Munich, Germany. Source: Erben, R G Mosekilde, L Thomsen, J S Weber, K Stahr, K Leyshon, A Smith, S Y Phipps, R J-Bone-Miner-Res. 2002 August; 17(8): 1498-511 0884-0431

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Prostaglandin E2 (PGE2) and risedronate was superior to PGE2 alone in maintaining newly added bone in the cortical bone site after withdrawal in older intact rats. Author(s): Division of Radiobiology, University of Utah School of Medicine, Salt Lake City, USA. Source: Ma, Y F Lin, B Y Jee, W S Lin, C H Chen, Y Y Ke, H Z Li, X J J-Bone-Miner-Res. 1997 February; 12(2): 267-75 0884-0431

•

Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. Author(s): Centre Universitaire d'Investigation du Metabolisme Osseux et du Cartilage Articulaire, University of Liege, Belgium. Source: Reginster, J Minne, H W Sorensen, O H Hooper, M Roux, C Brandi, M L Lund, B Ethgen, D Pack, S Roumagnac, I Eastell, R Osteoporos-Int. 2000; 11(1): 83-91 0937-941X

26

Risedronate

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Response of bone mineral density to once-weekly administration of risedronate. Author(s): Endocrine-Hypertension Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115, USA. Source: Gordon, M S Gordon, M B Endocr-Pract. 2002 May-June; 8(3): 202-7 1530-891X

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Risedronate increases bone density and reduces vertebral fracture risk within one year in men on corticosteroid therapy. Author(s): University of Aberdeen, Foresterhill, UK. Source: Reid, D M Adami, S Devogelaer, J P Chines, A A Calcif-Tissue-Int. 2001 October; 69(4): 242-7 0171-967X

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Risedronate plus prostaglandin E2 is superior to prostaglandin E2 alone in maintaining the added bone after withdrawal in a non-growing bone site in ovariectomized rats. Author(s): Radiobiology Division, University of Utah, Salt Lake City 84112, USA. Source: Liang, H H Ma, Y F Jee, W S Pan, Z Setterberg, R B McOsker, J E Li, X J Bone. 1995 October; 17(4 Suppl): 335S-339S 8756-3282

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Risedronate pretreatment does not hamper the anabolic effects of prostaglandin E2 in ovx rats. Author(s): Radiobiology Division, University of Utah, Salt Lake City 84112, USA. Source: Li, Q N Jee, W S Ma, Y F Ke, H Z Xie, H Huang, L F Liang, N C Bone. 1995 October; 17(4 Suppl): 261S-266S 8756-3282

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Risedronate reduces the risk of first vertebral fracture in osteoporotic women. Author(s): Creighton University, Omaha, Nebraska 68131, USA. [email protected] Source: Heaney, R P Zizic, T M Fogelman, I Olszynski, W P Geusens, P Kasibhatla, C Alsayed, N Isaia, G Davie, M W Chesnut, C H 3rd Osteoporos-Int. 2002; 13(6): 501-5 0937-941X

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Risedronate reverses bone loss in postmenopausal women with low bone mass: results from a multinational, double-blind, placebo-controlled trial. BMD-MN Study Group. Author(s): Department of Nuclear Medicine, Guy's Hospital, London, United Kingdom. Source: Fogelman, I Ribot, C Smith, R Ethgen, D Sod, E Reginster, J Y J-Clin-EndocrinolMetab. 2000 May; 85(5): 1895-900 0021-972X

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Risedronate, a highly effective oral agent in the treatment of patients with severe Paget's disease. Author(s): John Wayne Cancer Institute, Santa Monica, California 90404, USA. Source: Singer, F R Clemens, T L Eusebio, R A Bekker, P J J-Clin-Endocrinol-Metab. 1998 June; 83(6): 1906-10 0021-972X

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The effect of dosing regimen on the pharmacokinetics of risedronate. Author(s): Procter & Gamble Pharmaceuticals, Mason, Ohio, USA. Source: Mitchell, D Y Heise, M A Pallone, K A Clay, M E Nesbitt, J D Russell, D A Melson, C W Br-J-Clin-Pharmacol. 1999 October; 48(4): 536-42 0306-5251

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The efficacy and tolerability of risedronate once a week for the treatment of postmenopausal osteoporosis. Author(s): Le Centre de recherche du CHUL, Laval University, Sainte-Foy, Quebec, Canada. [email protected] Source: Brown, J P Kendler, D L McClung, M R Emkey, R D Adachi, J D Bolognese, M A Li, Z Balske, A Lindsay, R Calcif-Tissue-Int. 2002 August; 71(2): 103-11 0171-967X

Nutrition 27

Federal Resources on Nutrition In addition to the IBIDS, the United States Department of Health and Human Services (HHS) and the United States Department of Agriculture (USDA) provide many sources of information on general nutrition and health. Recommended resources include: •

healthfinder®, HHS’s gateway to health information, including diet and nutrition: http://www.healthfinder.gov/scripts/SearchContext.asp?topic=238&page=0

•

The United States Department of Agriculture’s Web site dedicated to nutrition information: www.nutrition.gov

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The Food and Drug Administration’s Web site for federal food safety information: www.foodsafety.gov

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The National Action Plan on Overweight and Obesity sponsored by the United States Surgeon General: http://www.surgeongeneral.gov/topics/obesity/

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The Center for Food Safety and Applied Nutrition has an Internet site sponsored by the Food and Drug Administration and the Department of Health and Human Services: http://vm.cfsan.fda.gov/

•

Center for Nutrition Policy and Promotion sponsored by the United States Department of Agriculture: http://www.usda.gov/cnpp/

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Food and Nutrition Information Center, National Agricultural Library sponsored by the United States Department of Agriculture: http://www.nal.usda.gov/fnic/

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Food and Nutrition Service sponsored by the United States Department of Agriculture: http://www.fns.usda.gov/fns/

Additional Web Resources A number of additional Web sites offer encyclopedic information covering food and nutrition. The following is a representative sample: •

AOL: http://search.aol.com/cat.adp?id=174&layer=&from=subcats

•

Family Village: http://www.familyvillage.wisc.edu/med_nutrition.html

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Google: http://directory.google.com/Top/Health/Nutrition/

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Healthnotes: http://www.healthnotes.com/

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Open Directory Project: http://dmoz.org/Health/Nutrition/

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Yahoo.com: http://dir.yahoo.com/Health/Nutrition/

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WebMDHealth: http://my.webmd.com/nutrition

•

WholeHealthMD.com: http://www.wholehealthmd.com/reflib/0,1529,00.html

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Risedronate

The following is a specific Web list relating to risedronate; please note that any particular subject below may indicate either a therapeutic use, or a contraindication (potential danger), and does not reflect an official recommendation: •

Minerals Calcium Source: Healthnotes, Inc.; www.healthnotes.com Iron Source: Healthnotes, Inc.; www.healthnotes.com Magnesium Source: Healthnotes, Inc.; www.healthnotes.com Zinc Source: Healthnotes, Inc.; www.healthnotes.com

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CHAPTER 3. CLINICAL TRIALS AND RISEDRONATE Overview In this chapter, we will show you how to keep informed of the latest clinical trials concerning risedronate.

Recent Trials on Risedronate The following is a list of recent trials dedicated to risedronate.5 Further information on a trial is available at the Web site indicated. •

Calcium With or Without Estrogen and/or Risedronate in Preventing Osteoporosis in Patients with Prostate Cancer Condition(s): Osteoporosis; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer Study Status: This study is currently recruiting patients. Sponsor(s): North Central Cancer Treatment Group; National Cancer Institute (NCI) Purpose - Excerpt: RATIONALE: Preventing bone loss in patients who are undergoing androgen ablation for prostate cancer may decrease the risk of fractures and may help patients live more comfortably. It is not yet known whether calcium is more effective with or without estrogen and/or risedronate in preventing osteoporosis. PURPOSE: Randomizedphase III trial to compare the effectiveness of two forms of calcium with or without estrogen and/or risedronate in preventing osteoporosis in patients with prostate cancer who are receiving androgen ablation therapy. Phase(s): Phase III Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/show/NCT00043069

5

These are listed at www.ClinicalTrials.gov.

30

Risedronate

•

Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer Condition(s): Osteoporosis; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer Study Status: This study is currently recruiting patients. Sponsor(s): North Central Cancer Treatment Group; National Cancer Institute (NCI) Purpose - Excerpt: RATIONALE: Preventing bone loss in patients who are receiving chemotherapy for breast cancer may decrease the risk of fractures and may help patients live more comfortably. It is not yet known whether calcium is more effective with or without risedronate in preventing bone loss. PURPOSE: Randomizedphase III trial to compare the effectiveness of two forms of calcium with or without risedronate in preventing bone loss in premenopausal women who are receiving chemotherapy for primarystage I, stage II, or stage IIIA breast cancer. Phase(s): Phase III Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/show/NCT00054418

Keeping Current on Clinical Trials The U.S. National Institutes of Health, through the National Library of Medicine, has developed ClinicalTrials.gov to provide current information about clinical research across the broadest number of diseases and conditions. The site was launched in February 2000 and currently contains approximately 5,700 clinical studies in over 59,000 locations worldwide, with most studies being conducted in the United States. ClinicalTrials.gov receives about 2 million hits per month and hosts approximately 5,400 visitors daily. To access this database, simply go to the Web site at http://www.clinicaltrials.gov/ and search by “risedronate” (or synonyms). While ClinicalTrials.gov is the most comprehensive listing of NIH-supported clinical trials available, not all trials are in the database. The database is updated regularly, so clinical trials are continually being added. The following is a list of specialty databases affiliated with the National Institutes of Health that offer additional information on trials: •

For clinical studies at the Warren Grant Magnuson Clinical Center located in Bethesda, Maryland, visit their Web site: http://clinicalstudies.info.nih.gov/

•

For clinical studies conducted at the Bayview Campus in Baltimore, Maryland, visit their Web site: http://www.jhbmc.jhu.edu/studies/index.html

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For cancer trials, visit the National Cancer Institute: http://cancertrials.nci.nih.gov/

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For eye-related trials, visit and search the Web page of the National Eye Institute: http://www.nei.nih.gov/neitrials/index.htm

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For heart, lung and blood trials, visit the Web page of the National Heart, Lung and Blood Institute: http://www.nhlbi.nih.gov/studies/index.htm

Clinical Trials 31

•

For trials on aging, visit and search the Web site of the National Institute on Aging: http://www.grc.nia.nih.gov/studies/index.htm

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For rare diseases, visit and search the Web site sponsored by the Office of Rare Diseases: http://ord.aspensys.com/asp/resources/rsch_trials.asp

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For alcoholism, visit the National Institute on Alcohol Abuse and Alcoholism: http://www.niaaa.nih.gov/intramural/Web_dicbr_hp/particip.htm

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For trials on infectious, immune, and allergic diseases, visit the site of the National Institute of Allergy and Infectious Diseases: http://www.niaid.nih.gov/clintrials/

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For trials on arthritis, musculoskeletal and skin diseases, visit newly revised site of the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health: http://www.niams.nih.gov/hi/studies/index.htm

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For hearing-related trials, visit the National Institute on Deafness and Other Communication Disorders: http://www.nidcd.nih.gov/health/clinical/index.htm

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For trials on diseases of the digestive system and kidneys, and diabetes, visit the National Institute of Diabetes and Digestive and Kidney Diseases: http://www.niddk.nih.gov/patient/patient.htm

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For drug abuse trials, visit and search the Web site sponsored by the National Institute on Drug Abuse: http://www.nida.nih.gov/CTN/Index.htm

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For trials on mental disorders, visit and search the Web site of the National Institute of Mental Health: http://www.nimh.nih.gov/studies/index.cfm

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For trials on neurological disorders and stroke, visit and search the Web site sponsored by the National Institute of Neurological Disorders and Stroke of the NIH: http://www.ninds.nih.gov/funding/funding_opportunities.htm#Clinical_Trials

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CHAPTER 4. PATENTS ON RISEDRONATE Overview Patents can be physical innovations (e.g. chemicals, pharmaceuticals, medical equipment) or processes (e.g. treatments or diagnostic procedures). The United States Patent and Trademark Office defines a patent as a grant of a property right to the inventor, issued by the Patent and Trademark Office.6 Patents, therefore, are intellectual property. For the United States, the term of a new patent is 20 years from the date when the patent application was filed. If the inventor wishes to receive economic benefits, it is likely that the invention will become commercially available within 20 years of the initial filing. It is important to understand, therefore, that an inventor’s patent does not indicate that a product or service is or will be commercially available. The patent implies only that the inventor has “the right to exclude others from making, using, offering for sale, or selling” the invention in the United States. While this relates to U.S. patents, similar rules govern foreign patents. In this chapter, we show you how to locate information on patents and their inventors. If you find a patent that is particularly interesting to you, contact the inventor or the assignee for further information. IMPORTANT NOTE: When following the search strategy described below, you may discover non-medical patents that use the generic term “risedronate” (or a synonym) in their titles. To accurately reflect the results that you might find while conducting research on risedronate, we have not necessarily excluded nonmedical patents in this bibliography.

Patents on Risedronate By performing a patent search focusing on risedronate, you can obtain information such as the title of the invention, the names of the inventor(s), the assignee(s) or the company that owns or controls the patent, a short abstract that summarizes the patent, and a few excerpts from the description of the patent. The abstract of a patent tends to be more technical in nature, while the description is often written for the public. Full patent descriptions contain much more information than is presented here (e.g. claims, references, figures, diagrams, etc.). We will tell you how to obtain this information later in the chapter. The following is an 6Adapted

from the United States Patent and Trademark Office: http://www.uspto.gov/web/offices/pac/doc/general/whatis.htm.

34

Risedronate

example of the type of information that you can expect to obtain from a patent search on risedronate: •

Dosage forms of risedronate Inventor(s): Axelrod; Douglas W. (Norwich, NY), Dansereau; Richard J. (Sherburne, NY), Mosher; Russell Y. (Norwich, NY), Sietsema; William K. (Norwich, NY) Assignee(s): The Procter & Gamble Company (cincinnati, Oh) Patent Number: 5,622,721 Date filed: September 14, 1994 Abstract: The present invention is directed to a novel enteric-coated oral dosage form of a risedronate active ingredient comprised of a safe and effective amount of a pharmaceutical composition which is comprised of a risedronate active ingredient and pharmaceutically-acceptable excipients. Said dosage forms prohibit the exposure of the risedronate active ingredient to the epithelial and mucosal tissues of the buccal cavity, pharynx, esophagus, and stomach and thereby protects said tissues from erosion, ulceration or other like irritation. Accordingly, the said dosage forms effect the delivery to the lower gastrointestinal tract of said human or other mammal of a safe and effective amount of the risedronate active ingredient, and substantially alleviate the esophagitis or esophageal irritation which occasionally accompanies the oral administration of risedronate active ingredients. Excerpt(s): The present invention relates to novel oral dosage forms of the diphosphonate compound, 3-pyridyl-1-hydroxyethylidene-1,1-bisphosphonic acid, hereinafter referred to as "risedronate". Said novel dosage forms are enteric-coated and delay the release of the risedronate until the lower gastrointestinal tract is reached, thereby protecting the epithelial and mucosal tissues of the mouth and the buccal cavity, the pharynx, the larynx, and the esophagus from erosion, ulceration, or other like irritation suffered by direct contact of these tissues with the risedronate active ingredient which may sometimes result from the oral administration of risedronate. This invention further relates to a method of treating or preventing diseases characterized by abnormal calcium and phosphate metabolism using the novel enteric coated dosage forms described herein. 1. Conditions which are characterized by anomalous mobilization of calcium and phosphate leading to general or specific bone loss or excessively high calcium and phosphate levels in the fluids of the body. Such conditions are sometimes referred to herein as patholological hard tissue demineralizations. 2. Conditions which cause or result from deposition of calcium and phosphate anomalously in the body. These conditions are sometimes referred to herein as pathological calcifications. Web site: http://www.delphion.com/details?pn=US05622721__

•

Risedronate in oral compositions Inventor(s): Shinoda; Hisashi (Sendai, JP) Assignee(s): The Procter & Gamble Company (cincinnati, Oh) Patent Number: 5,283,057 Date filed: April 24, 1992

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Abstract: The present invention relates to compositions and methods which are effective against alveolar bone resorption and enhance the ability of a tooth moved in orthodontic therapy to remain in its new position or to stay in its original position when adjacent teeth are moved. Excerpt(s): The present invention relates to compositions and methods which are effective against alveolar bone resorption and stabilization of teeth which have been moved in orthodontic therapy. Problems are faced in orthodontic therapy in that when teeth are moved they have the tendency to move back towards their original position or teeth that are not intended to be moved do move. To resist this, the underlying bone structure must not be allowed to be weakened or lost. Bone loss is extremely dangerous and causes the support for the teeth to be lost and subsequently the teeth themselves. In addition, alveolar bone resorption is a problem faced in subjects suffering from periodontal disease. Several different therapy processes have been used to treat alveolar bone resorption. However there is still a need to find improved therapies. The present inventor has found that certain geminal diphosphonic acid compounds, including their salts and esters, in which the diphosphonic acid-containing carbon is linked to a 6 member aromatic ring containing one or more nitrogen atoms are effective against alveolar bone loss and unwanted tooth movement. Web site: http://www.delphion.com/details?pn=US05283057__

Patent Applications on Risedronate As of December 2000, U.S. patent applications are open to public viewing.7 Applications are patent requests which have yet to be granted. (The process to achieve a patent can take several years.) The following patent applications have been filed since December 2000 relating to risedronate: •

Novel dosage forms of risedronate Inventor(s): Axelrod, Douglas Wayne; (Milford, OH), Dansereau, Richard John; (Cincinnati, OH), Mosher, Russell James; (Binghamton, NY), Sietsema, William Kendall; (West Chester, OH) Correspondence: The Procter & Gamble Company; Intellectual Property Division; Winton Hill Technical Center - Box 161; 6110 Center Hill Avenue; Cincinnati; OH; 45224; US Patent Application Number: 20040037884 Date filed: June 6, 2003 Abstract: The present invention is directed to a novel enteric-coated oral dosage form of a risedronate active ingredient comprised of a safe and effective amount of a pharmaceutical compostion which is comprised of a risedronate active ingredient and pharmaceutically-acceptable excipients. Said dosage forms prohibit the exposure of the risedronate active ingredient to the epithelial and mucosal tissues of the buccal cavity, pharynx, esophagus, and stomach and thereby protects said tissues from erosion, ulceration or other like irritation. Accordingly, the said dosage forms effect the delivery to the lower intestinal tract of said human or other mammal of a safe and effective amount of the risedronate active ingredient, and substantially alleviate the esophagitis

7

This has been a common practice outside the United States prior to December 2000.

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Risedronate

or esophageal irritation which sometimes accompanies the oral administration of risedronate active ingredients. Excerpt(s): The present invention relates to novel oral dosage forms of the diphosphonate compound, 3-pyridyl-1-hydroxyethylidene-1,1-bisphosphonic acid, hereinafter referred to as "risedronate". Said novel dosage forms are enteric-coated and delay the release of the risedronate until the lower intestinal tract is reached, thereby protecting the epithelial and mucosal tissues of the mouth and the buccal cavity, the pharynx, the larynx, and the esophagus from erosion, ulceration, or other like irritation suffered by direct contact of these tissues with the risedronate active ingredient which may sometimes result from the oral administration of risedronate. This invention further relates to a method of treating or preventing diseases characterized by abnormal calcium and phosphate metabolism using the novel enteric coated dosage forms described herein. 1. Conditions which are characterized by anomalous mobilization of calcium and phosphate leading to general or specific bone loss or excessively high calcium and phosphate levels in the fluids of the body. Such conditions are sometimes referred to herein as pathological hard tissue demineralizations. The compound risedronate is a more biologically potent diphosphonate compound which can be administered at low dosage levels; these lower dosage levels have resulted in a wider margin of safety and cause little or no mineralization inhibition. It is believed that the decrease in the inhibition of bone mineralization which is exhibited by the low dosage levels occurs because mineralization inhibition is predominately a mass related physiochemical effect, whereas resorption inhibition results from a biological interaction with the cells. In addition, low dosage levels are also desirable to avoid the gastrointestinal discomfort, like nausea, diarrhea, and abdominal pains, which are sometimes associated with the oral administration of disphosphonates. Web site: http://appft1.uspto.gov/netahtml/PTO/search-bool.html •

Novel polymorphs and pseudopolymorphs of risedronate sodium Inventor(s): Aronhime, Judith; (Rehovot, IL), Kovalevski-Ishai, Eti; (Netanya, IL), LidorHadas, Rami; (Kfar Saba, IL), Lifshitz-Liron, Revital; (Herzlia, IL) Correspondence: Kenyon & Kenyon; One Broadway; New York; NY; 10004; US Patent Application Number: 20030195170 Date filed: January 6, 2003 Abstract: Provided are novel polymorphs and pseudopolymorphs of risedronate sodium and risedronate disodium, methods for making them, and pharmaceutical compositions containing them. Excerpt(s): This application claims the benefit of provisional applications Serial No. 60/372,465, filed Apr. 11, 2002; Serial No. 60/404,174, filed Aug. 16, 2002, and Serial No. 60/405,668, filed Aug. 22, 2002. The present invention relates to novel polymorphs and pseudopolymorphs of risedronate sodium and methods of making them. The invention further relates to pharmaceutical compositions containing risedronate sodium in various polymorphic or pseudopolymorphic forms. Osteoporosis is a disease characterized by a progressive loss of bone mineral. Osteoporosis is also characterized by low bone mass and architectural deterioration of bone tissue leading to enhanced bone fragility and increase in the risk of fracture. The goal of therapy in treatment of osteoporosis is to improve calcium absorption and decrease urinary excretion of calcium thus reversing secondary hyperparathyroidism. Calcium supplements are widely used

Patents

37

in managing established osteoporosis but there have been few satisfactory prospective studies of calcium supplementation on bone density or the risk of further fracture. The bisphosphonates, for example etidronate, pamidronate, and risedronate are useful in treating osteoporosis. Risedronate sodium [1-hydroxy-2(3-pyridinyl)ethylidene] bis phosphonic acid monosodium salt), the subject of the present invention, is presently marketed under the tradename Actonel.RTM. for treatment of osteoporosis. Web site: http://appft1.uspto.gov/netahtml/PTO/search-bool.html

Keeping Current In order to stay informed about patents and patent applications dealing with risedronate, you can access the U.S. Patent Office archive via the Internet at the following Web address: http://www.uspto.gov/patft/index.html. You will see two broad options: (1) Issued Patent, and (2) Published Applications. To see a list of issued patents, perform the following steps: Under “Issued Patents,” click “Quick Search.” Then, type “risedronate” (or synonyms) into the “Term 1” box. After clicking on the search button, scroll down to see the various patents which have been granted to date on risedronate. You can also use this procedure to view pending patent applications concerning risedronate. Simply go back to http://www.uspto.gov/patft/index.html. Select “Quick Search” under “Published Applications.” Then proceed with the steps listed above.

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CHAPTER 5. PERIODICALS AND NEWS ON RISEDRONATE Overview In this chapter, we suggest a number of news sources and present various periodicals that cover risedronate.

News Services and Press Releases One of the simplest ways of tracking press releases on risedronate is to search the news wires. In the following sample of sources, we will briefly describe how to access each service. These services only post recent news intended for public viewing. PR Newswire To access the PR Newswire archive, simply go to http://www.prnewswire.com/. Select your country. Type “risedronate” (or synonyms) into the search box. You will automatically receive information on relevant news releases posted within the last 30 days. The search results are shown by order of relevance. Reuters Health The Reuters’ Medical News and Health eLine databases can be very useful in exploring news archives relating to risedronate. While some of the listed articles are free to view, others are available for purchase for a nominal fee. To access this archive, go to http://www.reutershealth.com/en/index.html and search by “risedronate” (or synonyms). The following was recently listed in this archive for risedronate: •

Risedronate seen as well tolerated in alendronate-intolerant patients Source: Reuters Industry Breifing Date: September 28, 2000

•

Fewer gastric ulcers seen with risedronate than with alendronate Source: Reuters Industry Breifing Date: September 26, 2000

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•

Risedronate prevents corticosteroid-induced bone loss Source: Reuters Medical News Date: November 16, 1999

•

Risedronate reduces fracture risk in postmenopausal women with osteoporosis Source: Reuters Medical News Date: October 13, 1999

•

Risedronate reduces fracture risk significantly in osteoporotic women Source: Reuters Medical News Date: June 14, 1999

•

Risedronate superior to etidronate for management of Paget's disease Source: Reuters Medical News Date: May 26, 1999

•

HMR, PG file for US and European approval of Actonel Source: Reuters Medical News Date: December 18, 1998

•

FDA Approves Risedronate For Treating Paget's Disease Source: Reuters Medical News Date: April 03, 1998

•

Risedronate Prevents Bone Loss In Early Postmenopausal Women Source: Reuters Medical News Date: March 06, 1998

•

Procter amp; Gamble, Hoechst To Collaborate On Risedronate Source: Reuters Medical News Date: May 06, 1997

•

Risedronate Increases BMD In Breast Cancer Patients With Artificially Induced Menopause Source: Reuters Medical News Date: March 20, 1997

•

Increased BMD explains only small portion of fracture risk reduction with Actonel Source: Reuters Industry Breifing Date: June 19, 2003

•

Extension study strongly suggests sustained anti-fracture effect of Actonel Source: Reuters Industry Breifing Date: June 19, 2003

•

Risedronate curbs osteoporotic fractures in high-risk postmenopausal women Source: Reuters Industry Breifing Date: March 03, 2003

•

Merck pits Fosamax osteoporosis drug head-to-head with rival Actonel Source: Reuters Industry Breifing Date: February 05, 2003

•

Risedronate cuts risk of severe osteoporotic fracture by nearly 70% within 1 year Source: Reuters Industry Breifing Date: September 23, 2002

•

Weekly risedronate effective in reducing osteoporotic fracture Source: Reuters Medical News Date: June 24, 2002

Periodicals and News 41

•

PG earns FDA approval for once-a-week Actonel Source: Reuters Industry Breifing Date: May 20, 2002

•

FDA approves once-a-week Actonel Source: Reuters Medical News Date: May 20, 2002

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Proctor Gamble's Actonel approved in Japan Source: Reuters Industry Breifing Date: January 17, 2002

•

FDA letter objects to PG Actonel ads Source: Reuters Industry Breifing Date: November 30, 2001

•

Combination of risedronate and HRT improves BMD in postmenopausal women Source: Reuters Industry Breifing Date: June 21, 2001

•

Risedronate primarily benefits elderly women with diagnosed osteoporosis Source: Reuters Industry Breifing Date: January 31, 2001 The NIH

Within MEDLINEplus, the NIH has made an agreement with the New York Times Syndicate, the AP News Service, and Reuters to deliver news that can be browsed by the public. Search news releases at http://www.nlm.nih.gov/medlineplus/alphanews_a.html. MEDLINEplus allows you to browse across an alphabetical index. Or you can search by date at the following Web page: http://www.nlm.nih.gov/medlineplus/newsbydate.html. Often, news items are indexed by MEDLINEplus within its search engine. Business Wire Business Wire is similar to PR Newswire. To access this archive, simply go to http://www.businesswire.com/. You can scan the news by industry category or company name. Market Wire Market Wire is more focused on technology than the other wires. To browse the latest press releases by topic, such as alternative medicine, biotechnology, fitness, healthcare, legal, nutrition, and pharmaceuticals, access Market Wire’s Medical/Health channel at http://www.marketwire.com/mw/release_index?channel=MedicalHealth. Or simply go to Market Wire’s home page at http://www.marketwire.com/mw/home, type “risedronate” (or synonyms) into the search box, and click on “Search News.” As this service is technology oriented, you may wish to use it when searching for press releases covering diagnostic procedures or tests.

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Search Engines Medical news is also available in the news sections of commercial Internet search engines. See the health news page at Yahoo (http://dir.yahoo.com/Health/News_and_Media/), or you can use this Web site’s general news search page at http://news.yahoo.com/. Type in “risedronate” (or synonyms). If you know the name of a company that is relevant to risedronate, you can go to any stock trading Web site (such as http://www.etrade.com/) and search for the company name there. News items across various news sources are reported on indicated hyperlinks. Google offers a similar service at http://news.google.com/. BBC Covering news from a more European perspective, the British Broadcasting Corporation (BBC) allows the public free access to their news archive located at http://www.bbc.co.uk/. Search by “risedronate” (or synonyms).

Newsletter Articles Use the Combined Health Information Database, and limit your search criteria to “newsletter articles.” Again, you will need to use the “Detailed Search” option. Go directly to the following hyperlink: http://chid.nih.gov/detail/detail.html. Go to the bottom of the search page where “You may refine your search by.” Select the dates and language that you prefer. For the format option, select “Newsletter Article.” Type “risedronate” (or synonyms) into the “For these words:” box. You should check back periodically with this database as it is updated every three months. The following is a typical result when searching for newsletter articles on risedronate: •

Glucocorticoid-Induced Osteoporosis in SLE Source: Lupus News. 23(1): 24-25. Spring 2003. Contact: Available from Lupus Foundation of America. 1300 Piccard Drive, Suite 200, Rockville, MD 20850-4303. (800) 558-0121 or (301) 670-9486. Website: www.lupus.org/lupus. Summary: This newsletter article discusses glucocorticoid-induced osteoporosis (GIOP), a less recognized but serious side effect of glucocorticoids, in patients with systemic lupus erythematosus (SLE). Glucocorticoids (steroids) have long been used in the treatment of patients with SLE. Steroids lower bone mass by slowing the function of osteoblasts which leads to a reduction of bone formation, increasing bone resorption, disrupting the metabolism of calcium, and affecting the hormones which lead to bone loss. To prevent GIOP, patients should take the lowest dosage of steroids that is effective or stop taking steroids altogether, consume 1500 mg of calcium per day, supplement vitamin D consumption to 800 IU per day, take biphosphonates such as alendronate, risedronate, and pamidronate to prevent bone resorption, use hormone replacement therapy if female, start an exercise program, stop smoking, and use alcohol and caffeine in moderation or not at all.

•

Osteopenia: When You Have Weak Bones, but Not Osteoporosis Source: Harvard Health Letter. 28(12): 6. October 2003.

Periodicals and News 43

Contact: Available from Harvard Health Publications. P.O. Box 421073, Palm Coast, FL 32141-1073. (800) 829-9045. Email: [email protected]. Summary: This newsletter article discusses osteopenia, a condition in which bone mineral density is lower than normal. This condition affects about half of Americans over the age of 50. Although women are more likely to have low bone density, approximately one-third of all white and Asian men over 50 are affected. Bone mineral density is measured by dual-energy x-ray absorptiometry. The bigger the negative number in the 'T-score' (the measurement of bone density) the more below standard and the more porous the bones are. There is also a greater chance that a fracture will occur. Risk factors for developing weak bones include not getting enough calcium or vitamin D, smoking, drinking too much, using certain medications such as corticosteroids and anticonvulsants, and not getting enough weight-bearing exercise. Osteopenia can be treated with exercise, nutrition, or medications. Medications used to treat osteopenia include alendronate, risedronate, and raloxifene. The National Osteoporosis Foundation recommends that women aged 65 years and older, postmenopausal women younger than 65 with at least one risk factor, and postmenopausal women who already have had a fracture should get a bone mineral density test.

Academic Periodicals covering Risedronate Numerous periodicals are currently indexed within the National Library of Medicine’s PubMed database that are known to publish articles relating to risedronate. In addition to these sources, you can search for articles covering risedronate that have been published by any of the periodicals listed in previous chapters. To find the latest studies published, go to http://www.ncbi.nlm.nih.gov/pubmed, type the name of the periodical into the search box, and click “Go.” If you want complete details about the historical contents of a journal, you can also visit the following Web site: http://www.ncbi.nlm.nih.gov/entrez/jrbrowser.cgi. Here, type in the name of the journal or its abbreviation, and you will receive an index of published articles. At http://locatorplus.gov/, you can retrieve more indexing information on medical periodicals (e.g. the name of the publisher). Select the button “Search LOCATORplus.” Then type in the name of the journal and select the advanced search option “Journal Title Search.”

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CHAPTER 6. RESEARCHING MEDICATIONS Overview While a number of hard copy or CD-ROM resources are available for researching medications, a more flexible method is to use Internet-based databases. Broadly speaking, there are two sources of information on approved medications: public sources and private sources. We will emphasize free-to-use public sources.

U.S. Pharmacopeia Because of historical investments by various organizations and the emergence of the Internet, it has become rather simple to learn about the medications recommended for risedronate. One such source is the United States Pharmacopeia. In 1820, eleven physicians met in Washington, D.C. to establish the first compendium of standard drugs for the United States. They called this compendium the U.S. Pharmacopeia (USP). Today, the USP is a nonprofit organization consisting of 800 volunteer scientists, eleven elected officials, and 400 representatives of state associations and colleges of medicine and pharmacy. The USP is located in Rockville, Maryland, and its home page is located at http://www.usp.org/. The USP currently provides standards for over 3,700 medications. The resulting USP DI Advice for the Patient can be accessed through the National Library of Medicine of the National Institutes of Health. The database is partially derived from lists of federally approved medications in the Food and Drug Administration’s (FDA) Drug Approvals database, located at http://www.fda.gov/cder/da/da.htm. While the FDA database is rather large and difficult to navigate, the Phamacopeia is both user-friendly and free to use. It covers more than 9,000 prescription and over-the-counter medications. To access this database, simply type the following hyperlink into your Web browser: http://www.nlm.nih.gov/medlineplus/druginformation.html. To view examples of a given medication (brand names, category, description, preparation, proper use, precautions, side effects, etc.), simply follow the hyperlinks indicated within the United States Pharmacopeia (USP). Below, we have compiled a list of medications associated with risedronate. If you would like more information on a particular medication, the provided hyperlinks will direct you to ample documentation (e.g. typical dosage, side effects, drug-interaction risks, etc.). The

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following drugs have been mentioned in the Pharmacopeia and other sources as being potentially applicable to risedronate: Risedronate •

Systemic - U.S. Brands: Actonel http://www.nlm.nih.gov/medlineplus/druginfo/uspdi/203554.html

Commercial Databases In addition to the medications listed in the USP above, a number of commercial sites are available by subscription to physicians and their institutions. Or, you may be able to access these sources from your local medical library.

Mosby’s Drug Consult Mosby’s Drug Consult database (also available on CD-ROM and book format) covers 45,000 drug products including generics and international brands. It provides prescribing information, drug interactions, and patient information. Subscription information is available at the following hyperlink: http://www.mosbysdrugconsult.com/. PDRhealth The PDRhealth database is a free-to-use, drug information search engine that has been written for the public in layman’s terms. It contains FDA-approved drug information adapted from the Physicians’ Desk Reference (PDR) database. PDRhealth can be searched by brand name, generic name, or indication. It features multiple drug interactions reports. Search PDRhealth at http://www.pdrhealth.com/drug_info/index.html. Other Web Sites Drugs.com (www.drugs.com) reproduces the information in the Pharmacopeia as well as commercial information. You may also want to consider the Web site of the Medical Letter, Inc. (http://www.medletter.com/) which allows users to download articles on various drugs and therapeutics for a nominal fee. If you have any questions about a medical treatment, the FDA may have an office near you. Look for their number in the blue pages of the phone book. You can also contact the FDA through its toll-free number, 1-888-INFO-FDA (1-888-463-6332), or on the World Wide Web at www.fda.gov.

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APPENDICES

49

APPENDIX A. PHYSICIAN RESOURCES Overview In this chapter, we focus on databases and Internet-based guidelines and information resources created or written for a professional audience.

NIH Guidelines Commonly referred to as “clinical” or “professional” guidelines, the National Institutes of Health publish physician guidelines for the most common diseases. Publications are available at the following by relevant Institute8: •

Office of the Director (OD); guidelines consolidated across agencies available at http://www.nih.gov/health/consumer/conkey.htm

•

National Institute of General Medical Sciences (NIGMS); fact sheets available at http://www.nigms.nih.gov/news/facts/

•

National Library of Medicine (NLM); extensive encyclopedia (A.D.A.M., Inc.) with guidelines: http://www.nlm.nih.gov/medlineplus/healthtopics.html

•

National Cancer Institute (NCI); guidelines available at http://www.cancer.gov/cancerinfo/list.aspx?viewid=5f35036e-5497-4d86-8c2c714a9f7c8d25

•

National Eye Institute (NEI); guidelines available at http://www.nei.nih.gov/order/index.htm

•

National Heart, Lung, and Blood Institute (NHLBI); guidelines available at http://www.nhlbi.nih.gov/guidelines/index.htm

•

National Human Genome Research Institute (NHGRI); research available at http://www.genome.gov/page.cfm?pageID=10000375

•

National Institute on Aging (NIA); guidelines available at http://www.nia.nih.gov/health/

8

These publications are typically written by one or more of the various NIH Institutes.

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•

National Institute on Alcohol Abuse and Alcoholism (NIAAA); guidelines available at http://www.niaaa.nih.gov/publications/publications.htm

•

National Institute of Allergy and Infectious Diseases (NIAID); guidelines available at http://www.niaid.nih.gov/publications/

•

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); fact sheets and guidelines available at http://www.niams.nih.gov/hi/index.htm

•

National Institute of Child Health and Human Development (NICHD); guidelines available at http://www.nichd.nih.gov/publications/pubskey.cfm

•

National Institute on Deafness and Other Communication Disorders (NIDCD); fact sheets and guidelines at http://www.nidcd.nih.gov/health/

•

National Institute of Dental and Craniofacial Research (NIDCR); guidelines available at http://www.nidr.nih.gov/health/

•

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); guidelines available at http://www.niddk.nih.gov/health/health.htm

•

National Institute on Drug Abuse (NIDA); guidelines available at http://www.nida.nih.gov/DrugAbuse.html

•

National Institute of Environmental Health Sciences (NIEHS); environmental health information available at http://www.niehs.nih.gov/external/facts.htm

•

National Institute of Mental Health (NIMH); guidelines available at http://www.nimh.nih.gov/practitioners/index.cfm

•

National Institute of Neurological Disorders and Stroke (NINDS); neurological disorder information pages available at http://www.ninds.nih.gov/health_and_medical/disorder_index.htm

•

National Institute of Nursing Research (NINR); publications on selected illnesses at http://www.nih.gov/ninr/news-info/publications.html

•

National Institute of Biomedical Imaging and Bioengineering; general information at http://grants.nih.gov/grants/becon/becon_info.htm

•

Center for Information Technology (CIT); referrals to other agencies based on keyword searches available at http://kb.nih.gov/www_query_main.asp

•

National Center for Complementary and Alternative Medicine (NCCAM); health information available at http://nccam.nih.gov/health/

•

National Center for Research Resources (NCRR); various information directories available at http://www.ncrr.nih.gov/publications.asp

•

Office of Rare Diseases; various fact sheets available at http://rarediseases.info.nih.gov/html/resources/rep_pubs.html

•

Centers for Disease Control and Prevention; various fact sheets on infectious diseases available at http://www.cdc.gov/publications.htm

Physician Resources 51

NIH Databases In addition to the various Institutes of Health that publish professional guidelines, the NIH has designed a number of databases for professionals.9 Physician-oriented resources provide a wide variety of information related to the biomedical and health sciences, both past and present. The format of these resources varies. Searchable databases, bibliographic citations, full-text articles (when available), archival collections, and images are all available. The following are referenced by the National Library of Medicine:10 •

Bioethics: Access to published literature on the ethical, legal, and public policy issues surrounding healthcare and biomedical research. This information is provided in conjunction with the Kennedy Institute of Ethics located at Georgetown University, Washington, D.C.: http://www.nlm.nih.gov/databases/databases_bioethics.html

•

HIV/AIDS Resources: Describes various links and databases dedicated to HIV/AIDS research: http://www.nlm.nih.gov/pubs/factsheets/aidsinfs.html

•

NLM Online Exhibitions: Describes “Exhibitions in the History of Medicine”: http://www.nlm.nih.gov/exhibition/exhibition.html. Additional resources for historical scholarship in medicine: http://www.nlm.nih.gov/hmd/hmd.html

•

Biotechnology Information: Access to public databases. The National Center for Biotechnology Information conducts research in computational biology, develops software tools for analyzing genome data, and disseminates biomedical information for the better understanding of molecular processes affecting human health and disease: http://www.ncbi.nlm.nih.gov/

•

Population Information: The National Library of Medicine provides access to worldwide coverage of population, family planning, and related health issues, including family planning technology and programs, fertility, and population law and policy: http://www.nlm.nih.gov/databases/databases_population.html

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Cancer Information: Access to cancer-oriented databases: http://www.nlm.nih.gov/databases/databases_cancer.html

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Profiles in Science: Offering the archival collections of prominent twentieth-century biomedical scientists to the public through modern digital technology: http://www.profiles.nlm.nih.gov/

•

Chemical Information: Provides links to various chemical databases and references: http://sis.nlm.nih.gov/Chem/ChemMain.html

•

Clinical Alerts: Reports the release of findings from the NIH-funded clinical trials where such release could significantly affect morbidity and mortality: http://www.nlm.nih.gov/databases/alerts/clinical_alerts.html

•

Space Life Sciences: Provides links and information to space-based research (including NASA): http://www.nlm.nih.gov/databases/databases_space.html

•

MEDLINE: Bibliographic database covering the fields of medicine, nursing, dentistry, veterinary medicine, the healthcare system, and the pre-clinical sciences: http://www.nlm.nih.gov/databases/databases_medline.html

9

Remember, for the general public, the National Library of Medicine recommends the databases referenced in MEDLINEplus (http://medlineplus.gov/ or http://www.nlm.nih.gov/medlineplus/databases.html). 10 See http://www.nlm.nih.gov/databases/databases.html.

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•

Toxicology and Environmental Health Information (TOXNET): Databases covering toxicology and environmental health: http://sis.nlm.nih.gov/Tox/ToxMain.html

•

Visible Human Interface: Anatomically detailed, three-dimensional representations of normal male and female human bodies: http://www.nlm.nih.gov/research/visible/visible_human.html

The NLM Gateway11 The NLM (National Library of Medicine) Gateway is a Web-based system that lets users search simultaneously in multiple retrieval systems at the U.S. National Library of Medicine (NLM). It allows users of NLM services to initiate searches from one Web interface, providing one-stop searching for many of NLM’s information resources or databases.12 To use the NLM Gateway, simply go to the search site at http://gateway.nlm.nih.gov/gw/Cmd. Type “risedronate” (or synonyms) into the search box and click “Search.” The results will be presented in a tabular form, indicating the number of references in each database category. Results Summary Category Journal Articles Books / Periodicals / Audio Visual Consumer Health Meeting Abstracts Other Collections Total

Items Found 379 0 24 0 2 405

HSTAT13 HSTAT is a free, Web-based resource that provides access to full-text documents used in healthcare decision-making.14 These documents include clinical practice guidelines, quickreference guides for clinicians, consumer health brochures, evidence reports and technology assessments from the Agency for Healthcare Research and Quality (AHRQ), as well as AHRQ’s Put Prevention Into Practice.15 Simply search by “risedronate” (or synonyms) at the following Web site: http://text.nlm.nih.gov.

11

Adapted from NLM: http://gateway.nlm.nih.gov/gw/Cmd?Overview.x.

12

The NLM Gateway is currently being developed by the Lister Hill National Center for Biomedical Communications (LHNCBC) at the National Library of Medicine (NLM) of the National Institutes of Health (NIH). 13 Adapted from HSTAT: http://www.nlm.nih.gov/pubs/factsheets/hstat.html. 14 15

The HSTAT URL is http://hstat.nlm.nih.gov/.

Other important documents in HSTAT include: the National Institutes of Health (NIH) Consensus Conference Reports and Technology Assessment Reports; the HIV/AIDS Treatment Information Service (ATIS) resource documents; the Substance Abuse and Mental Health Services Administration's Center for Substance Abuse Treatment (SAMHSA/CSAT) Treatment Improvement Protocols (TIP) and Center for Substance Abuse Prevention (SAMHSA/CSAP) Prevention Enhancement Protocols System (PEPS); the Public Health Service (PHS) Preventive Services Task Force's Guide to Clinical Preventive Services; the independent, nonfederal Task Force on Community Services’ Guide to Community Preventive Services; and the Health Technology Advisory Committee (HTAC) of the Minnesota Health Care Commission (MHCC) health technology evaluations.

Physician Resources 53

Coffee Break: Tutorials for Biologists16 Coffee Break is a general healthcare site that takes a scientific view of the news and covers recent breakthroughs in biology that may one day assist physicians in developing treatments. Here you will find a collection of short reports on recent biological discoveries. Each report incorporates interactive tutorials that demonstrate how bioinformatics tools are used as a part of the research process. Currently, all Coffee Breaks are written by NCBI staff.17 Each report is about 400 words and is usually based on a discovery reported in one or more articles from recently published, peer-reviewed literature.18 This site has new articles every few weeks, so it can be considered an online magazine of sorts. It is intended for general background information. You can access the Coffee Break Web site at the following hyperlink: http://www.ncbi.nlm.nih.gov/Coffeebreak/.

Other Commercial Databases In addition to resources maintained by official agencies, other databases exist that are commercial ventures addressing medical professionals. Here are some examples that may interest you: •

CliniWeb International: Index and table of contents to selected clinical information on the Internet; see http://www.ohsu.edu/cliniweb/.

•

Medical World Search: Searches full text from thousands of selected medical sites on the Internet; see http://www.mwsearch.com/.

16 Adapted 17

from http://www.ncbi.nlm.nih.gov/Coffeebreak/Archive/FAQ.html.

The figure that accompanies each article is frequently supplied by an expert external to NCBI, in which case the source of the figure is cited. The result is an interactive tutorial that tells a biological story. 18 After a brief introduction that sets the work described into a broader context, the report focuses on how a molecular understanding can provide explanations of observed biology and lead to therapies for diseases. Each vignette is accompanied by a figure and hypertext links that lead to a series of pages that interactively show how NCBI tools and resources are used in the research process.

55

APPENDIX B. PATIENT RESOURCES Overview Official agencies, as well as federally funded institutions supported by national grants, frequently publish a variety of guidelines written with the patient in mind. These are typically called “Fact Sheets” or “Guidelines.” They can take the form of a brochure, information kit, pamphlet, or flyer. Often they are only a few pages in length. Since new guidelines on risedronate can appear at any moment and be published by a number of sources, the best approach to finding guidelines is to systematically scan the Internet-based services that post them.

Patient Guideline Sources The remainder of this chapter directs you to sources which either publish or can help you find additional guidelines on topics related to risedronate. Due to space limitations, these sources are listed in a concise manner. Do not hesitate to consult the following sources by either using the Internet hyperlink provided, or, in cases where the contact information is provided, contacting the publisher or author directly. The National Institutes of Health The NIH gateway to patients is located at http://health.nih.gov/. From this site, you can search across various sources and institutes, a number of which are summarized below. Topic Pages: MEDLINEplus The National Library of Medicine has created a vast and patient-oriented healthcare information portal called MEDLINEplus. Within this Internet-based system are “health topic pages” which list links to available materials relevant to risedronate. To access this system, log on to http://www.nlm.nih.gov/medlineplus/healthtopics.html. From there you can either search using the alphabetical index or browse by broad topic areas. Recently, MEDLINEplus listed the following when searched for “risedronate”:

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Bone Diseases http://www.nlm.nih.gov/medlineplus/bonediseases.html Fractures http://www.nlm.nih.gov/medlineplus/fractures.html Hormone Replacement Therapy http://www.nlm.nih.gov/medlineplus/hormonereplacementtherapy.html Osteogenesis Imperfecta http://www.nlm.nih.gov/medlineplus/osteogenesisimperfecta.html Osteoporosis http://www.nlm.nih.gov/medlineplus/osteoporosis.html Paget's Disease of Bone http://www.nlm.nih.gov/medlineplus/pagetsdiseaseofbone.html You may also choose to use the search utility provided by MEDLINEplus at the following Web address: http://www.nlm.nih.gov/medlineplus/. Simply type a keyword into the search box and click “Search.” This utility is similar to the NIH search utility, with the exception that it only includes materials that are linked within the MEDLINEplus system (mostly patient-oriented information). It also has the disadvantage of generating unstructured results. We recommend, therefore, that you use this method only if you have a very targeted search. The Combined Health Information Database (CHID) CHID Online is a reference tool that maintains a database directory of thousands of journal articles and patient education guidelines on risedronate. CHID offers summaries that describe the guidelines available, including contact information and pricing. CHID’s general Web site is http://chid.nih.gov/. To search this database, go to http://chid.nih.gov/detail/detail.html. In particular, you can use the advanced search options to look up pamphlets, reports, brochures, and information kits. The following was recently posted in this archive: •

Questions and Answers About Bisphosphonates Source: Osteogenesis Imperfecta Foundation. October 2002. 3 p. Contact: Available online from Osteogenesis Imperfecta Foundation. Website: www.oif.org. Summary: This fact sheet discusses using bisphosphonate therapy to treat children and adults with osteogenesis imperfecta (OI). Bisphosphonates are drugs that slow the process of bone resorption and promote bone growth. Early studies with the bisphosphonates pamidronate, alendronate, risedronate, and zoledronate show increases in bone density and cortical bone width, decreases in bone porosity, and reduction of bone pain. Side effects of pamidronate include flu-like symptoms, temporary decreases in blood cell count, and slow healing of osteotomy cuts. Alendronate and risedronate may cause gastric discomfort, severe esophageal burning, muscle pain, eye irritation, and headaches. Bisphosphonates may cause birth defects if taken during pregnancy or at the time of conception. These drugs work best when used in conjunction with nutritional supplements and exercise. Research with bisphosphonate therapy is ongoing.

Patient Resources 57

The National Guideline Clearinghouse™ The National Guideline Clearinghouse™ offers hundreds of evidence-based clinical practice guidelines published in the United States and other countries. You can search this site located at http://www.guideline.gov/ by using the keyword “risedronate” (or synonyms). The following was recently posted: •

American Gastroenterological Association medical position statement: guidelines on osteoporosis in gastrointestinal diseases Source: American Gastroenterological Association - Medical Specialty Society; 2003 March; 4 pages http://www.guideline.gov/summary/summary.aspx?doc_id=3697&nbr=2923&a mp;string=risedronate

•

Diagnosis and treatment of osteoporosis Source: Institute for Clinical Systems Improvement - Private Nonprofit Organization; 2002 August; 67 pages http://www.guideline.gov/summary/summary.aspx?doc_id=3411&nbr=2637&a mp;string=risedronate

•

Management of postmenopausal osteoporosis: position statement of The North American Menopause Society Source: The North American Menopause Society - Private Nonprofit Organization; 2002 March; 18 pages http://www.guideline.gov/summary/summary.aspx?doc_id=3179&nbr=2405&a mp;string=risedronate

•

Osteoporosis Source: Singapore Ministry of Health - National Government Agency [Non-U.S.]; 2002 February; 63 pages http://www.guideline.gov/summary/summary.aspx?doc_id=3435&nbr=2661&a mp;string=risedronate

•

Osteoporosis prevention, diagnosis, and therapy Source: National Institutes of Health (NIH) Consensus Development Panel on Osteoporosis Prevention, Diagnosis, and Therapy - Independent Expert Panel; 2000 March 27-29; 36 pages http://www.guideline.gov/summary/summary.aspx?doc_id=2535&nbr=1761&a mp;string=risedronate

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•

Osteoporosis. Guide to prevention, diagnosis, and treatment Source: Brigham and Women's Hospital (Boston) - Hospital/Medical Center; 1999 (revised 2001); 11 pages http://www.guideline.gov/summary/summary.aspx?doc_id=3430&nbr=2656&a mp;string=risedronate

•

Osteoporosis: prevention and treatment Source: University of Michigan Health System - Academic Institution; 2002 March; 12 pages http://www.guideline.gov/summary/summary.aspx?doc_id=3541&nbr=2767&a mp;string=risedronate

•

Physician's guide to prevention and treatment of osteoporosis Source: American Academy of Orthopaedic Surgeons - Medical Specialty Society; 1999 (revised 2003 Apr); 37 pages http://www.guideline.gov/summary/summary.aspx?doc_id=3862&nbr=3073&a mp;string=risedronate

•

Prevention and management of hip fracture in older people. A national clinical guideline Source: Scottish Intercollegiate Guidelines Network - National Government Agency [Non-U.S.]; 2002 January; 40 pages http://www.guideline.gov/summary/summary.aspx?doc_id=3184&nbr=2410&a mp;string=risedronate

•

Recommendations for the prevention and treatment of glucocorticoid-induced osteoporosis: 2001 update Source: American College of Rheumatology - Medical Specialty Society; 1996 September 3 (updated 2001); 8 pages http://www.guideline.gov/summary/summary.aspx?doc_id=2934&nbr=2160&a mp;string=risedronate

•

Screening for osteoporosis in postmenopausal women: recommendations and rationale Source: United States Preventive Services Task Force - Independent Expert Panel; 1996 (revised 2002 September 17); 12 pages http://www.guideline.gov/summary/summary.aspx?doc_id=3417&nbr=2643&a mp;string=risedronate

Patient Resources 59

The NIH Search Utility The NIH search utility allows you to search for documents on over 100 selected Web sites that comprise the NIH-WEB-SPACE. Each of these servers is “crawled” and indexed on an ongoing basis. Your search will produce a list of various documents, all of which will relate in some way to risedronate. The drawbacks of this approach are that the information is not organized by theme and that the references are often a mix of information for professionals and patients. Nevertheless, a large number of the listed Web sites provide useful background information. We can only recommend this route, therefore, for relatively rare or specific disorders, or when using highly targeted searches. To use the NIH search utility, visit the following Web page: http://search.nih.gov/index.html. Additional Web Sources A number of Web sites are available to the public that often link to government sites. These can also point you in the direction of essential information. The following is a representative sample: •

AOL: http://search.aol.com/cat.adp?id=168&layer=&from=subcats

•

Family Village: http://www.familyvillage.wisc.edu/specific.htm

•

Google: http://directory.google.com/Top/Health/Conditions_and_Diseases/

•

Med Help International: http://www.medhelp.org/HealthTopics/A.html

•

Open Directory Project: http://dmoz.org/Health/Conditions_and_Diseases/

•

Yahoo.com: http://dir.yahoo.com/Health/Diseases_and_Conditions/

•

WebMDHealth: http://my.webmd.com/health_topics

Finding Associations There are several Internet directories that provide lists of medical associations with information on or resources relating to risedronate. By consulting all of associations listed in this chapter, you will have nearly exhausted all sources for patient associations concerned with risedronate. The National Health Information Center (NHIC) The National Health Information Center (NHIC) offers a free referral service to help people find organizations that provide information about risedronate. For more information, see the NHIC’s Web site at http://www.health.gov/NHIC/ or contact an information specialist by calling 1-800-336-4797. Directory of Health Organizations The Directory of Health Organizations, provided by the National Library of Medicine Specialized Information Services, is a comprehensive source of information on associations. The Directory of Health Organizations database can be accessed via the Internet at

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Risedronate

http://www.sis.nlm.nih.gov/Dir/DirMain.html. It is composed of two parts: DIRLINE and Health Hotlines. The DIRLINE database comprises some 10,000 records of organizations, research centers, and government institutes and associations that primarily focus on health and biomedicine. To access DIRLINE directly, go to the following Web site: http://dirline.nlm.nih.gov/. Simply type in “risedronate” (or a synonym), and you will receive information on all relevant organizations listed in the database. Health Hotlines directs you to toll-free numbers to over 300 organizations. You can access this database directly at http://www.sis.nlm.nih.gov/hotlines/. On this page, you are given the option to search by keyword or by browsing the subject list. When you have received your search results, click on the name of the organization for its description and contact information. The Combined Health Information Database Another comprehensive source of information on healthcare associations is the Combined Health Information Database. Using the “Detailed Search” option, you will need to limit your search to “Organizations” and “risedronate”. Type the following hyperlink into your Web browser: http://chid.nih.gov/detail/detail.html. To find associations, use the drop boxes at the bottom of the search page where “You may refine your search by.” For publication date, select “All Years.” Then, select your preferred language and the format option “Organization Resource Sheet.” Type “risedronate” (or synonyms) into the “For these words:” box. You should check back periodically with this database since it is updated every three months. The National Organization for Rare Disorders, Inc. The National Organization for Rare Disorders, Inc. has prepared a Web site that provides, at no charge, lists of associations organized by health topic. You can access this database at the following Web site: http://www.rarediseases.org/search/orgsearch.html. Type “risedronate” (or a synonym) into the search box, and click “Submit Query.”

61

APPENDIX C. FINDING MEDICAL LIBRARIES Overview In this Appendix, we show you how to quickly find a medical library in your area.

Preparation Your local public library and medical libraries have interlibrary loan programs with the National Library of Medicine (NLM), one of the largest medical collections in the world. According to the NLM, most of the literature in the general and historical collections of the National Library of Medicine is available on interlibrary loan to any library. If you would like to access NLM medical literature, then visit a library in your area that can request the publications for you.19

Finding a Local Medical Library The quickest method to locate medical libraries is to use the Internet-based directory published by the National Network of Libraries of Medicine (NN/LM). This network includes 4626 members and affiliates that provide many services to librarians, health professionals, and the public. To find a library in your area, simply visit http://nnlm.gov/members/adv.html or call 1-800-338-7657.

Medical Libraries in the U.S. and Canada In addition to the NN/LM, the National Library of Medicine (NLM) lists a number of libraries with reference facilities that are open to the public. The following is the NLM’s list and includes hyperlinks to each library’s Web site. These Web pages can provide information on hours of operation and other restrictions. The list below is a small sample of

19

Adapted from the NLM: http://www.nlm.nih.gov/psd/cas/interlibrary.html.

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libraries recommended by the National Library of Medicine (sorted alphabetically by name of the U.S. state or Canadian province where the library is located)20: •

Alabama: Health InfoNet of Jefferson County (Jefferson County Library Cooperative, Lister Hill Library of the Health Sciences), http://www.uab.edu/infonet/

•

Alabama: Richard M. Scrushy Library (American Sports Medicine Institute)

•

Arizona: Samaritan Regional Medical Center: The Learning Center (Samaritan Health System, Phoenix, Arizona), http://www.samaritan.edu/library/bannerlibs.htm

•

California: Kris Kelly Health Information Center (St. Joseph Health System, Humboldt), http://www.humboldt1.com/~kkhic/index.html

•

California: Community Health Library of Los Gatos, http://www.healthlib.org/orgresources.html

•

California: Consumer Health Program and Services (CHIPS) (County of Los Angeles Public Library, Los Angeles County Harbor-UCLA Medical Center Library) - Carson, CA, http://www.colapublib.org/services/chips.html

•

California: Gateway Health Library (Sutter Gould Medical Foundation)

•

California: Health Library (Stanford University Medical Center), http://wwwmed.stanford.edu/healthlibrary/

•

California: Patient Education Resource Center - Health Information and Resources (University of California, San Francisco), http://sfghdean.ucsf.edu/barnett/PERC/default.asp

•

California: Redwood Health Library (Petaluma Health Care District), http://www.phcd.org/rdwdlib.html

•

California: Los Gatos PlaneTree Health Library, http://planetreesanjose.org/

•

California: Sutter Resource Library (Sutter Hospitals Foundation, Sacramento), http://suttermedicalcenter.org/library/

•

California: Health Sciences Libraries (University of California, Davis), http://www.lib.ucdavis.edu/healthsci/

•

California: ValleyCare Health Library & Ryan Comer Cancer Resource Center (ValleyCare Health System, Pleasanton), http://gaelnet.stmarysca.edu/other.libs/gbal/east/vchl.html

•

California: Washington Community Health Resource Library (Fremont), http://www.healthlibrary.org/

•

Colorado: William V. Gervasini Memorial Library (Exempla Healthcare), http://www.saintjosephdenver.org/yourhealth/libraries/

•

Connecticut: Hartford Hospital Health Science Libraries (Hartford Hospital), http://www.harthosp.org/library/

•

Connecticut: Healthnet: Connecticut Consumer Health Information Center (University of Connecticut Health Center, Lyman Maynard Stowe Library), http://library.uchc.edu/departm/hnet/

20

Abstracted from http://www.nlm.nih.gov/medlineplus/libraries.html.

Finding Medical Libraries 63

•

Connecticut: Waterbury Hospital Health Center Library (Waterbury Hospital, Waterbury), http://www.waterburyhospital.com/library/consumer.shtml

•

Delaware: Consumer Health Library (Christiana Care Health System, Eugene du Pont Preventive Medicine & Rehabilitation Institute, Wilmington), http://www.christianacare.org/health_guide/health_guide_pmri_health_info.cfm

•

Delaware: Lewis B. Flinn Library (Delaware Academy of Medicine, Wilmington), http://www.delamed.org/chls.html

•

Georgia: Family Resource Library (Medical College of Georgia, Augusta), http://cmc.mcg.edu/kids_families/fam_resources/fam_res_lib/frl.htm

•

Georgia: Health Resource Center (Medical Center of Central Georgia, Macon), http://www.mccg.org/hrc/hrchome.asp

•

Hawaii: Hawaii Medical Library: Consumer Health Information Service (Hawaii Medical Library, Honolulu), http://hml.org/CHIS/

•

Idaho: DeArmond Consumer Health Library (Kootenai Medical Center, Coeur d’Alene), http://www.nicon.org/DeArmond/index.htm

•

Illinois: Health Learning Center of Northwestern Memorial Hospital (Chicago), http://www.nmh.org/health_info/hlc.html

•

Illinois: Medical Library (OSF Saint Francis Medical Center, Peoria), http://www.osfsaintfrancis.org/general/library/

•

Kentucky: Medical Library - Services for Patients, Families, Students & the Public (Central Baptist Hospital, Lexington), http://www.centralbap.com/education/community/library.cfm

•

Kentucky: University of Kentucky - Health Information Library (Chandler Medical Center, Lexington), http://www.mc.uky.edu/PatientEd/

•

Louisiana: Alton Ochsner Medical Foundation Library (Alton Ochsner Medical Foundation, New Orleans), http://www.ochsner.org/library/

•

Louisiana: Louisiana State University Health Sciences Center Medical LibraryShreveport, http://lib-sh.lsuhsc.edu/

•

Maine: Franklin Memorial Hospital Medical Library (Franklin Memorial Hospital, Farmington), http://www.fchn.org/fmh/lib.htm

•

Maine: Gerrish-True Health Sciences Library (Central Maine Medical Center, Lewiston), http://www.cmmc.org/library/library.html

•

Maine: Hadley Parrot Health Science Library (Eastern Maine Healthcare, Bangor), http://www.emh.org/hll/hpl/guide.htm

•

Maine: Maine Medical Center Library (Maine Medical Center, Portland), http://www.mmc.org/library/

•

Maine: Parkview Hospital (Brunswick), http://www.parkviewhospital.org/

•

Maine: Southern Maine Medical Center Health Sciences Library (Southern Maine Medical Center, Biddeford), http://www.smmc.org/services/service.php3?choice=10

•

Maine: Stephens Memorial Hospital’s Health Information Library (Western Maine Health, Norway), http://www.wmhcc.org/Library/

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•

Manitoba, Canada: Consumer & Patient Health Information Service (University of Manitoba Libraries), http://www.umanitoba.ca/libraries/units/health/reference/chis.html

•

Manitoba, Canada: J.W. Crane Memorial Library (Deer Lodge Centre, Winnipeg), http://www.deerlodge.mb.ca/crane_library/about.asp

•

Maryland: Health Information Center at the Wheaton Regional Library (Montgomery County, Dept. of Public Libraries, Wheaton Regional Library), http://www.mont.lib.md.us/healthinfo/hic.asp

•

Massachusetts: Baystate Medical Center Library (Baystate Health System), http://www.baystatehealth.com/1024/

•

Massachusetts: Boston University Medical Center Alumni Medical Library (Boston University Medical Center), http://med-libwww.bu.edu/library/lib.html

•

Massachusetts: Lowell General Hospital Health Sciences Library (Lowell General Hospital, Lowell), http://www.lowellgeneral.org/library/HomePageLinks/WWW.htm

•

Massachusetts: Paul E. Woodard Health Sciences Library (New England Baptist Hospital, Boston), http://www.nebh.org/health_lib.asp

•

Massachusetts: St. Luke’s Hospital Health Sciences Library (St. Luke’s Hospital, Southcoast Health System, New Bedford), http://www.southcoast.org/library/

•

Massachusetts: Treadwell Library Consumer Health Reference Center (Massachusetts General Hospital), http://www.mgh.harvard.edu/library/chrcindex.html

•

Massachusetts: UMass HealthNet (University of Massachusetts Medical School, Worchester), http://healthnet.umassmed.edu/

•

Michigan: Botsford General Hospital Library - Consumer Health (Botsford General Hospital, Library & Internet Services), http://www.botsfordlibrary.org/consumer.htm

•

Michigan: Helen DeRoy Medical Library (Providence Hospital and Medical Centers), http://www.providence-hospital.org/library/

•

Michigan: Marquette General Hospital - Consumer Health Library (Marquette General Hospital, Health Information Center), http://www.mgh.org/center.html

•

Michigan: Patient Education Resouce Center - University of Michigan Cancer Center (University of Michigan Comprehensive Cancer Center, Ann Arbor), http://www.cancer.med.umich.edu/learn/leares.htm

•

Michigan: Sladen Library & Center for Health Information Resources - Consumer Health Information (Detroit), http://www.henryford.com/body.cfm?id=39330

•

Montana: Center for Health Information (St. Patrick Hospital and Health Sciences Center, Missoula)

•

National: Consumer Health Library Directory (Medical Library Association, Consumer and Patient Health Information Section), http://caphis.mlanet.org/directory/index.html

•

National: National Network of Libraries of Medicine (National Library of Medicine) provides library services for health professionals in the United States who do not have access to a medical library, http://nnlm.gov/

•

National: NN/LM List of Libraries Serving the Public (National Network of Libraries of Medicine), http://nnlm.gov/members/

Finding Medical Libraries 65

•

Nevada: Health Science Library, West Charleston Library (Las Vegas-Clark County Library District, Las Vegas), http://www.lvccld.org/special_collections/medical/index.htm

•

New Hampshire: Dartmouth Biomedical Libraries (Dartmouth College Library, Hanover), http://www.dartmouth.edu/~biomed/resources.htmld/conshealth.htmld/

•

New Jersey: Consumer Health Library (Rahway Hospital, Rahway), http://www.rahwayhospital.com/library.htm

•

New Jersey: Dr. Walter Phillips Health Sciences Library (Englewood Hospital and Medical Center, Englewood), http://www.englewoodhospital.com/links/index.htm

•

New Jersey: Meland Foundation (Englewood Hospital and Medical Center, Englewood), http://www.geocities.com/ResearchTriangle/9360/

•

New York: Choices in Health Information (New York Public Library) - NLM Consumer Pilot Project participant, http://www.nypl.org/branch/health/links.html

•

New York: Health Information Center (Upstate Medical University, State University of New York, Syracuse), http://www.upstate.edu/library/hic/

•

New York: Health Sciences Library (Long Island Jewish Medical Center, New Hyde Park), http://www.lij.edu/library/library.html

•

New York: ViaHealth Medical Library (Rochester General Hospital), http://www.nyam.org/library/

•

Ohio: Consumer Health Library (Akron General Medical Center, Medical & Consumer Health Library), http://www.akrongeneral.org/hwlibrary.htm

•

Oklahoma: The Health Information Center at Saint Francis Hospital (Saint Francis Health System, Tulsa), http://www.sfh-tulsa.com/services/healthinfo.asp

•

Oregon: Planetree Health Resource Center (Mid-Columbia Medical Center, The Dalles), http://www.mcmc.net/phrc/

•

Pennsylvania: Community Health Information Library (Milton S. Hershey Medical Center, Hershey), http://www.hmc.psu.edu/commhealth/

•

Pennsylvania: Community Health Resource Library (Geisinger Medical Center, Danville), http://www.geisinger.edu/education/commlib.shtml

•

Pennsylvania: HealthInfo Library (Moses Taylor Hospital, Scranton), http://www.mth.org/healthwellness.html

•

Pennsylvania: Hopwood Library (University of Pittsburgh, Health Sciences Library System, Pittsburgh), http://www.hsls.pitt.edu/guides/chi/hopwood/index_html

•

Pennsylvania: Koop Community Health Information Center (College of Physicians of Philadelphia), http://www.collphyphil.org/kooppg1.shtml

•

Pennsylvania: Learning Resources Center - Medical Library (Susquehanna Health System, Williamsport), http://www.shscares.org/services/lrc/index.asp

•

Pennsylvania: Medical Library (UPMC Health System, Pittsburgh), http://www.upmc.edu/passavant/library.htm

•

Quebec, Canada: Medical Library (Montreal General Hospital), http://www.mghlib.mcgill.ca/

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•

South Dakota: Rapid City Regional Hospital Medical Library (Rapid City Regional Hospital), http://www.rcrh.org/Services/Library/Default.asp

•

Texas: Houston HealthWays (Houston Academy of Medicine-Texas Medical Center Library), http://hhw.library.tmc.edu/

•

Washington: Community Health Library (Kittitas Valley Community Hospital), http://www.kvch.com/

•

Washington: Southwest Washington Medical Center Library (Southwest Washington Medical Center, Vancouver), http://www.swmedicalcenter.com/body.cfm?id=72

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ONLINE GLOSSARIES The Internet provides access to a number of free-to-use medical dictionaries. The National Library of Medicine has compiled the following list of online dictionaries: •

ADAM Medical Encyclopedia (A.D.A.M., Inc.), comprehensive medical reference: http://www.nlm.nih.gov/medlineplus/encyclopedia.html

•

MedicineNet.com Medical Dictionary (MedicineNet, Inc.): http://www.medterms.com/Script/Main/hp.asp

•

Merriam-Webster Medical Dictionary (Inteli-Health, Inc.): http://www.intelihealth.com/IH/

•

Multilingual Glossary of Technical and Popular Medical Terms in Eight European Languages (European Commission) - Danish, Dutch, English, French, German, Italian, Portuguese, and Spanish: http://allserv.rug.ac.be/~rvdstich/eugloss/welcome.html

•

On-line Medical Dictionary (CancerWEB): http://cancerweb.ncl.ac.uk/omd/

•

Rare Diseases Terms (Office of Rare Diseases): http://ord.aspensys.com/asp/diseases/diseases.asp

•

Technology Glossary (National Library of Medicine) - Health Care Technology: http://www.nlm.nih.gov/nichsr/ta101/ta10108.htm

Beyond these, MEDLINEplus contains a very patient-friendly encyclopedia covering every aspect of medicine (licensed from A.D.A.M., Inc.). The ADAM Medical Encyclopedia can be accessed at http://www.nlm.nih.gov/medlineplus/encyclopedia.html. ADAM is also available on commercial Web sites such as drkoop.com (http://www.drkoop.com/) and Web MD (http://my.webmd.com/adam/asset/adam_disease_articles/a_to_z/a).

Online Dictionary Directories The following are additional online directories compiled by the National Library of Medicine, including a number of specialized medical dictionaries: •

Medical Dictionaries: Medical & Biological (World Health Organization): http://www.who.int/hlt/virtuallibrary/English/diction.htm#Medical

•

MEL-Michigan Electronic Library List of Online Health and Medical Dictionaries (Michigan Electronic Library): http://mel.lib.mi.us/health/health-dictionaries.html

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Patient Education: Glossaries (DMOZ Open Directory Project): http://dmoz.org/Health/Education/Patient_Education/Glossaries/

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Web of Online Dictionaries (Bucknell University): http://www.yourdictionary.com/diction5.html#medicine

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RISEDRONATE DICTIONARY The definitions below are derived from official public sources, including the National Institutes of Health [NIH] and the European Union [EU]. Abdomen: That portion of the body that lies between the thorax and the pelvis. [NIH] Abdominal: Having to do with the abdomen, which is the part of the body between the chest and the hips that contains the pancreas, stomach, intestines, liver, gallbladder, and other organs. [NIH] Abdominal Pain: Sensation of discomfort, distress, or agony in the abdominal region. [NIH] Ablation: The removal of an organ by surgery. [NIH] Adenosine: A nucleoside that is composed of adenine and d-ribose. Adenosine or adenosine derivatives play many important biological roles in addition to being components of DNA and RNA. Adenosine itself is a neurotransmitter. [NIH] Adjuvant: A substance which aids another, such as an auxiliary remedy; in immunology, nonspecific stimulator (e.g., BCG vaccine) of the immune response. [EU] Adrenal Cortex: The outer layer of the adrenal gland. It secretes mineralocorticoids, androgens, and glucocorticoids. [NIH] Adverse Effect: An unwanted side effect of treatment. [NIH] Affinity: 1. Inherent likeness or relationship. 2. A special attraction for a specific element, organ, or structure. 3. Chemical affinity; the force that binds atoms in molecules; the tendency of substances to combine by chemical reaction. 4. The strength of noncovalent chemical binding between two substances as measured by the dissociation constant of the complex. 5. In immunology, a thermodynamic expression of the strength of interaction between a single antigen-binding site and a single antigenic determinant (and thus of the stereochemical compatibility between them), most accurately applied to interactions among simple, uniform antigenic determinants such as haptens. Expressed as the association constant (K litres mole -1), which, owing to the heterogeneity of affinities in a population of antibody molecules of a given specificity, actually represents an average value (mean intrinsic association constant). 6. The reciprocal of the dissociation constant. [EU] Agonist: In anatomy, a prime mover. In pharmacology, a drug that has affinity for and stimulates physiologic activity at cell receptors normally stimulated by naturally occurring substances. [EU] Alendronate: A nonhormonal medication for the treatment of postmenopausal osteoporosis in women. This drug builds healthy bone, restoring some of the bone loss as a result of osteoporosis. [NIH] Alertness: A state of readiness to detect and respond to certain specified small changes occurring at random intervals in the environment. [NIH] Algorithms: A procedure consisting of a sequence of algebraic formulas and/or logical steps to calculate or determine a given task. [NIH] Alkaline: Having the reactions of an alkali. [EU] Alkaline Phosphatase: An enzyme that catalyzes the conversion of an orthophosphoric monoester and water to an alcohol and orthophosphate. EC 3.1.3.1. [NIH] Alternative medicine: Practices not generally recognized by the medical community as standard or conventional medical approaches and used instead of standard treatments.

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Alternative medicine includes the taking of dietary supplements, megadose vitamins, and herbal preparations; the drinking of special teas; and practices such as massage therapy, magnet therapy, spiritual healing, and meditation. [NIH] Alveolar Bone Loss: The resorption of bone in the supporting structures of the maxilla or mandible as a result of periodontal disease. [NIH] Alveolar Process: The thickest and spongiest part of the maxilla and mandible hollowed out into deep cavities for the teeth. [NIH] Ampulla: A sac-like enlargement of a canal or duct. [NIH] Anabolic: Relating to, characterized by, or promoting anabolism. [EU] Analgesics: Compounds capable of relieving pain without the loss of consciousness or without producing anesthesia. [NIH] Androgens: A class of sex hormones associated with the development and maintenance of the secondary male sex characteristics, sperm induction, and sexual differentiation. In addition to increasing virility and libido, they also increase nitrogen and water retention and stimulate skeletal growth. [NIH] Anemia: A reduction in the number of circulating erythrocytes or in the quantity of hemoglobin. [NIH] Anesthesia: A state characterized by loss of feeling or sensation. This depression of nerve function is usually the result of pharmacologic action and is induced to allow performance of surgery or other painful procedures. [NIH] Antagonism: Interference with, or inhibition of, the growth of a living organism by another living organism, due either to creation of unfavorable conditions (e. g. exhaustion of food supplies) or to production of a specific antibiotic substance (e. g. penicillin). [NIH] Antiallergic: Counteracting allergy or allergic conditions. [EU] Antibiotic: A drug used to treat infections caused by bacteria and other microorganisms. [NIH]

Anticonvulsants: Drugs used to prevent seizures or reduce their severity. [NIH] Anti-inflammatory: Having to do with reducing inflammation. [NIH] Anti-Inflammatory Agents: Substances that reduce or suppress inflammation. [NIH] Antineoplastic: Inhibiting or preventing the development of neoplasms, checking the maturation and proliferation of malignant cells. [EU] Arachidonic Acid: An unsaturated, essential fatty acid. It is found in animal and human fat as well as in the liver, brain, and glandular organs, and is a constituent of animal phosphatides. It is formed by the synthesis from dietary linoleic acid and is a precursor in the biosynthesis of prostaglandins, thromboxanes, and leukotrienes. [NIH] Aromatic: Having a spicy odour. [EU] Arteries: The vessels carrying blood away from the heart. [NIH] Ascorbic Acid: A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Vitamin C is considered an antioxidant. [NIH] Aspirin: A drug that reduces pain, fever, inflammation, and blood clotting. Aspirin belongs to the family of drugs called nonsteroidal anti-inflammatory agents. It is also being studied in cancer prevention. [NIH]

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Asymptomatic: Having no signs or symptoms of disease. [NIH] Bacteria: Unicellular prokaryotic microorganisms which generally possess rigid cell walls, multiply by cell division, and exhibit three principal forms: round or coccal, rodlike or bacillary, and spiral or spirochetal. [NIH] Base: In chemistry, the nonacid part of a salt; a substance that combines with acids to form salts; a substance that dissociates to give hydroxide ions in aqueous solutions; a substance whose molecule or ion can combine with a proton (hydrogen ion); a substance capable of donating a pair of electrons (to an acid) for the formation of a coordinate covalent bond. [EU] Biochemical: Relating to biochemistry; characterized by, produced by, or involving chemical reactions in living organisms. [EU] Biosynthesis: The building up of a chemical compound in the physiologic processes of a living organism. [EU] Biotechnology: Body of knowledge related to the use of organisms, cells or cell-derived constituents for the purpose of developing products which are technically, scientifically and clinically useful. Alteration of biologic function at the molecular level (i.e., genetic engineering) is a central focus; laboratory methods used include transfection and cloning technologies, sequence and structure analysis algorithms, computer databases, and gene and protein structure function analysis and prediction. [NIH] Biotransformation: The chemical alteration of an exogenous substance by or in a biological system. The alteration may inactivate the compound or it may result in the production of an active metabolite of an inactive parent compound. The alteration may be either nonsynthetic (oxidation-reduction, hydrolysis) or synthetic (glucuronide formation, sulfate conjugation, acetylation, methylation). This also includes metabolic detoxication and clearance. [NIH] Bladder: The organ that stores urine. [NIH] Blastocyst: The mammalian embryo in the post-morula stage in which a fluid-filled cavity, enclosed primarily by trophoblast, contains an inner cell mass which becomes the embryonic disc. [NIH] Blood Cell Count: A count of the number of leukocytes and erythrocytes per unit volume in a sample of venous blood. A complete blood count (CBC) also includes measurement of the hemoglobin, hematocrit, and erythrocyte indices. [NIH] Blood Coagulation: The process of the interaction of blood coagulation factors that results in an insoluble fibrin clot. [NIH] Blood pressure: The pressure of blood against the walls of a blood vessel or heart chamber. Unless there is reference to another location, such as the pulmonary artery or one of the heart chambers, it refers to the pressure in the systemic arteries, as measured, for example, in the forearm. [NIH] Blood vessel: A tube in the body through which blood circulates. Blood vessels include a network of arteries, arterioles, capillaries, venules, and veins. [NIH] Body Composition: The relative amounts of various components in the body, such as percent body fat. [NIH] Body Fluids: Liquid components of living organisms. [NIH] Body Mass Index: One of the anthropometric measures of body mass; it has the highest correlation with skinfold thickness or body density. [NIH] Bone Cements: Adhesives used to fix prosthetic devices to bones and to cement bone to bone in difficult fractures. Synthetic resins are commonly used as cements. A mixture of

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monocalcium phosphate, monohydrate, alpha-tricalcium phosphate, and calcium carbonate with a sodium phosphate solution is also a useful bone paste. [NIH] Bone Density: The amount of mineral per square centimeter of bone. This is the definition used in clinical practice. Actual bone density would be expressed in grams per milliliter. It is most frequently measured by photon absorptiometry or x-ray computed tomography. [NIH] Bone Marrow: The soft tissue filling the cavities of bones. Bone marrow exists in two types, yellow and red. Yellow marrow is found in the large cavities of large bones and consists mostly of fat cells and a few primitive blood cells. Red marrow is a hematopoietic tissue and is the site of production of erythrocytes and granular leukocytes. Bone marrow is made up of a framework of connective tissue containing branching fibers with the frame being filled with marrow cells. [NIH] Bone Remodeling: The continuous turnover of bone matrix and mineral that involves first, an increase in resorption (osteoclastic activity) and later, reactive bone formation (osteoblastic activity). The process of bone remodeling takes place in the adult skeleton at discrete foci. The process ensures the mechanical integrity of the skeleton throughout life and plays an important role in calcium homeostasis. An imbalance in the regulation of bone remodeling's two contrasting events, bone resorption and bone formation, results in many of the metabolic bone diseases, such as osteoporosis. [NIH] Bone Resorption: Bone loss due to osteoclastic activity. [NIH] Bowel: The long tube-shaped organ in the abdomen that completes the process of digestion. There is both a small and a large bowel. Also called the intestine. [NIH] Bowel Movement: Body wastes passed through the rectum and anus. [NIH] Branch: Most commonly used for branches of nerves, but applied also to other structures. [NIH]

Buccal: Pertaining to or directed toward the cheek. In dental anatomy, used to refer to the buccal surface of a tooth. [EU] Caffeine: A methylxanthine naturally occurring in some beverages and also used as a pharmacological agent. Caffeine's most notable pharmacological effect is as a central nervous system stimulant, increasing alertness and producing agitation. It also relaxes smooth muscle, stimulates cardiac muscle, stimulates diuresis, and appears to be useful in the treatment of some types of headache. Several cellular actions of caffeine have been observed, but it is not entirely clear how each contributes to its pharmacological profile. Among the most important are inhibition of cyclic nucleotide phosphodiesterases, antagonism of adenosine receptors, and modulation of intracellular calcium handling. [NIH] Calcitonin: A peptide hormone that lowers calcium concentration in the blood. In humans, it is released by thyroid cells and acts to decrease the formation and absorptive activity of osteoclasts. Its role in regulating plasma calcium is much greater in children and in certain diseases than in normal adults. [NIH] Calcium: A basic element found in nearly all organized tissues. It is a member of the alkaline earth family of metals with the atomic symbol Ca, atomic number 20, and atomic weight 40. Calcium is the most abundant mineral in the body and combines with phosphorus to form calcium phosphate in the bones and teeth. It is essential for the normal functioning of nerves and muscles and plays a role in blood coagulation (as factor IV) and in many enzymatic processes. [NIH] Capsules: Hard or soft soluble containers used for the oral administration of medicine. [NIH] Carbohydrate: An aldehyde or ketone derivative of a polyhydric alcohol, particularly of the pentahydric and hexahydric alcohols. They are so named because the hydrogen and oxygen are usually in the proportion to form water, (CH2O)n. The most important carbohydrates

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are the starches, sugars, celluloses, and gums. They are classified into mono-, di-, tri-, polyand heterosaccharides. [EU] Cardiac: Having to do with the heart. [NIH] Cell: The individual unit that makes up all of the tissues of the body. All living things are made up of one or more cells. [NIH] Cell Count: A count of the number of cells of a specific kind, usually measured per unit volume of sample. [NIH] Cellobiose: A disaccharide consisting of two glucose units in beta (1-4) glycosidic linkage. Obtained from the partial hydrolysis of cellulose. [NIH] Cellulose: A polysaccharide with glucose units linked as in cellobiose. It is the chief constituent of plant fibers, cotton being the purest natural form of the substance. As a raw material, it forms the basis for many derivatives used in chromatography, ion exchange materials, explosives manufacturing, and pharmaceutical preparations. [NIH] Central Nervous System: The main information-processing organs of the nervous system, consisting of the brain, spinal cord, and meninges. [NIH] Chemotherapy: Treatment with anticancer drugs. [NIH] Chin: The anatomical frontal portion of the mandible, also known as the mentum, that contains the line of fusion of the two separate halves of the mandible (symphysis menti). This line of fusion divides inferiorly to enclose a triangular area called the mental protuberance. On each side, inferior to the second premolar tooth, is the mental foramen for the passage of blood vessels and a nerve. [NIH] Cholesterol: The principal sterol of all higher animals, distributed in body tissues, especially the brain and spinal cord, and in animal fats and oils. [NIH] Chronic: A disease or condition that persists or progresses over a long period of time. [NIH] Clinical trial: A research study that tests how well new medical treatments or other interventions work in people. Each study is designed to test new methods of screening, prevention, diagnosis, or treatment of a disease. [NIH] Cloning: The production of a number of genetically identical individuals; in genetic engineering, a process for the efficient replication of a great number of identical DNA molecules. [NIH] Collagen: A polypeptide substance comprising about one third of the total protein in mammalian organisms. It is the main constituent of skin, connective tissue, and the organic substance of bones and teeth. Different forms of collagen are produced in the body but all consist of three alpha-polypeptide chains arranged in a triple helix. Collagen is differentiated from other fibrous proteins, such as elastin, by the content of proline, hydroxyproline, and hydroxylysine; by the absence of tryptophan; and particularly by the high content of polar groups which are responsible for its swelling properties. [NIH] Computational Biology: A field of biology concerned with the development of techniques for the collection and manipulation of biological data, and the use of such data to make biological discoveries or predictions. This field encompasses all computational methods and theories applicable to molecular biology and areas of computer-based techniques for solving biological problems including manipulation of models and datasets. [NIH] Conception: The onset of pregnancy, marked by implantation of the blastocyst; the formation of a viable zygote. [EU] Connective Tissue: Tissue that supports and binds other tissues. It consists of connective tissue cells embedded in a large amount of extracellular matrix. [NIH]

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Connective Tissue: Tissue that supports and binds other tissues. It consists of connective tissue cells embedded in a large amount of extracellular matrix. [NIH] Consciousness: Sense of awareness of self and of the environment. [NIH] Consumption: Pulmonary tuberculosis. [NIH] Contraindications: Any factor or sign that it is unwise to pursue a certain kind of action or treatment, e. g. giving a general anesthetic to a person with pneumonia. [NIH] Controlled study: An experiment or clinical trial that includes a comparison (control) group. [NIH]

Coronary: Encircling in the manner of a crown; a term applied to vessels; nerves, ligaments, etc. The term usually denotes the arteries that supply the heart muscle and, by extension, a pathologic involvement of them. [EU] Coronary Thrombosis: Presence of a thrombus in a coronary artery, often causing a myocardial infarction. [NIH] Cortex: The outer layer of an organ or other body structure, as distinguished from the internal substance. [EU] Cortical: Pertaining to or of the nature of a cortex or bark. [EU] Corticosteroid: Any of the steroids elaborated by the adrenal cortex (excluding the sex hormones of adrenal origin) in response to the release of corticotrophin (adrenocorticotropic hormone) by the pituitary gland, to any of the synthetic equivalents of these steroids, or to angiotensin II. They are divided, according to their predominant biological activity, into three major groups: glucocorticoids, chiefly influencing carbohydrate, fat, and protein metabolism; mineralocorticoids, affecting the regulation of electrolyte and water balance; and C19 androgens. Some corticosteroids exhibit both types of activity in varying degrees, and others exert only one type of effect. The corticosteroids are used clinically for hormonal replacement therapy, for suppression of ACTH secretion by the anterior pituitary, as antineoplastic, antiallergic, and anti-inflammatory agents, and to suppress the immune response. Called also adrenocortical hormone and corticoid. [EU] Curative: Tending to overcome disease and promote recovery. [EU] Cutaneous: Having to do with the skin. [NIH] Cyclic: Pertaining to or occurring in a cycle or cycles; the term is applied to chemical compounds that contain a ring of atoms in the nucleus. [EU] Databases, Bibliographic: Extensive collections, reputedly complete, of references and citations to books, articles, publications, etc., generally on a single subject or specialized subject area. Databases can operate through automated files, libraries, or computer disks. The concept should be differentiated from factual databases which is used for collections of data and facts apart from bibliographic references to them. [NIH] Density: The logarithm to the base 10 of the opacity of an exposed and processed film. [NIH] Deprivation: Loss or absence of parts, organs, powers, or things that are needed. [EU] Diagnostic Imaging: Any visual display of structural or functional patterns of organs or tissues for diagnostic evaluation. It includes measuring physiologic and metabolic responses to physical and chemical stimuli, as well as ultramicroscopy. [NIH] Diagnostic procedure: A method used to identify a disease. [NIH] Diarrhea: Passage of excessively liquid or excessively frequent stools. [NIH] Digestion: The process of breakdown of food for metabolism and use by the body. [NIH] Digestive system: The organs that take in food and turn it into products that the body can

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use to stay healthy. Waste products the body cannot use leave the body through bowel movements. The digestive system includes the salivary glands, mouth, esophagus, stomach, liver, pancreas, gallbladder, small and large intestines, and rectum. [NIH] Direct: 1. Straight; in a straight line. 2. Performed immediately and without the intervention of subsidiary means. [EU] Discrete: Made up of separate parts or characterized by lesions which do not become blended; not running together; separate. [NIH] Distal: Remote; farther from any point of reference; opposed to proximal. In dentistry, used to designate a position on the dental arch farther from the median line of the jaw. [EU] Diuresis: Increased excretion of urine. [EU] Dosage Forms: Completed forms of the pharmaceutical preparation in which prescribed doses of medication are included. They are designed to resist action by gastric fluids, prevent vomiting and nausea, reduce or alleviate the undesirable taste and smells associated with oral administration, achieve a high concentration of drug at target site, or produce a delayed or long-acting drug effect. They include capsules, liniments, ointments, pharmaceutical solutions, powders, tablets, etc. [NIH] Double-blind: Pertaining to a clinical trial or other experiment in which neither the subject nor the person administering treatment knows which treatment any particular subject is receiving. [EU] Drug Interactions: The action of a drug that may affect the activity, metabolism, or toxicity of another drug. [NIH] Duodenum: The first part of the small intestine. [NIH] Eating Disorders: A group of disorders characterized by physiological and psychological disturbances in appetite or food intake. [NIH] Efficacy: The extent to which a specific intervention, procedure, regimen, or service produces a beneficial result under ideal conditions. Ideally, the determination of efficacy is based on the results of a randomized control trial. [NIH] Elastin: The protein that gives flexibility to tissues. [NIH] Electrolyte: A substance that dissociates into ions when fused or in solution, and thus becomes capable of conducting electricity; an ionic solute. [EU] Embryo: The prenatal stage of mammalian development characterized by rapid morphological changes and the differentiation of basic structures. [NIH] Endoscope: A thin, lighted tube used to look at tissues inside the body. [NIH] Endoscopic: A technique where a lateral-view endoscope is passed orally to the duodenum for visualization of the ampulla of Vater. [NIH] Endoscopy: Endoscopic examination, therapy or surgery performed on interior parts of the body. [NIH] Enteric-coated: A term designating a special coating applied to tablets or capsules which prevents release and absorption of their contents until they reach the intestines. [EU] Environmental Health: The science of controlling or modifying those conditions, influences, or forces surrounding man which relate to promoting, establishing, and maintaining health. [NIH]

Enzymatic: Phase where enzyme cuts the precursor protein. [NIH] Enzyme: A protein that speeds up chemical reactions in the body. [NIH] Epithelial: Refers to the cells that line the internal and external surfaces of the body. [NIH]

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Erythrocyte Indices: Quantification of size and cell hemoglobin content or concentration of the erythrocyte, usually derived from erythrocyte count, blood hemoglobin concentration, and hematocrit. Includes the mean cell volume (MCV), mean cell hemoglobin (MCH), and mean cell hemoglobin concentration (MCHC). Use also for cell diameter and thickness. [NIH] Erythrocytes: Red blood cells. Mature erythrocytes are non-nucleated, biconcave disks containing hemoglobin whose function is to transport oxygen. [NIH] Esophageal: Having to do with the esophagus, the muscular tube through which food passes from the throat to the stomach. [NIH] Esophageal Stricture: A narrowing of the esophagus often caused by acid flowing back from the stomach. This condition may require surgery. [NIH] Esophagitis: Inflammation, acute or chronic, of the esophagus caused by bacteria, chemicals, or trauma. [NIH] Esophagus: The muscular tube through which food passes from the throat to the stomach. [NIH]

Estrogen: One of the two female sex hormones. [NIH] Estrogen receptor: ER. Protein found on some cancer cells to which estrogen will attach. [NIH]

Estrogen receptor positive: ER+. Breast cancer cells that have a protein (receptor molecule) to which estrogen will attach. Breast cancer cells that are ER+ need the hormone estrogen to grow and will usually respond to hormone (antiestrogen) therapy that blocks these receptor sites. [NIH] Etidronate: A drug that belongs to the family of drugs called bisphosphonates. Bisphosphonates are used as treatment for hypercalcemia (abnormally high levels of calcium in the blood) and for cancer that has spread to the bone (bone metastases). [NIH] Evacuation: An emptying, as of the bowels. [EU] Excipients: Usually inert substances added to a prescription in order to provide suitable consistency to the dosage form; a binder, matrix, base or diluent in pills, tablets, creams, salves, etc. [NIH] Exogenous: Developed or originating outside the organism, as exogenous disease. [EU] Extracellular: Outside a cell or cells. [EU] Extracellular Matrix: A meshwork-like substance found within the extracellular space and in association with the basement membrane of the cell surface. It promotes cellular proliferation and provides a supporting structure to which cells or cell lysates in culture dishes adhere. [NIH] Family Planning: Programs or services designed to assist the family in controlling reproduction by either improving or diminishing fertility. [NIH] Fat: Total lipids including phospholipids. [NIH] Fatty acids: A major component of fats that are used by the body for energy and tissue development. [NIH] Femoral: Pertaining to the femur, or to the thigh. [EU] Femoral Neck Fractures: Fractures of the short, constricted portion of the thigh bone between the femur head and the trochanters. It excludes intertrochanteric fractures which are hip fractures. [NIH] Femur: The longest and largest bone of the skeleton, it is situated between the hip and the knee. [NIH]

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Fibula: The bone of the lower leg lateral to and smaller than the tibia. In proportion to its length, it is the most slender of the long bones. [NIH] Fistula: Abnormal communication most commonly seen between two internal organs, or between an internal organ and the surface of the body. [NIH] Forearm: The part between the elbow and the wrist. [NIH] Gallbladder: The pear-shaped organ that sits below the liver. Bile is concentrated and stored in the gallbladder. [NIH] Gas: Air that comes from normal breakdown of food. The gases are passed out of the body through the rectum (flatus) or the mouth (burp). [NIH] Gastric: Having to do with the stomach. [NIH] Gastric Emptying: The evacuation of food from the stomach into the duodenum. [NIH] Gastrin: A hormone released after eating. Gastrin causes the stomach to produce more acid. [NIH]

Gastroduodenal: Pertaining to or communicating with the stomach and duodenum, as a gastroduodenal fistula. [EU] Gastrointestinal: Refers to the stomach and intestines. [NIH] Gastrointestinal tract: The stomach and intestines. [NIH] Gelatin: A product formed from skin, white connective tissue, or bone collagen. It is used as a protein food adjuvant, plasma substitute, hemostatic, suspending agent in pharmaceutical preparations, and in the manufacturing of capsules and suppositories. [NIH] Gene: The functional and physical unit of heredity passed from parent to offspring. Genes are pieces of DNA, and most genes contain the information for making a specific protein. [NIH]

Gland: An organ that produces and releases one or more substances for use in the body. Some glands produce fluids that affect tissues or organs. Others produce hormones or participate in blood production. [NIH] Glucocorticoid: A compound that belongs to the family of compounds called corticosteroids (steroids). Glucocorticoids affect metabolism and have anti-inflammatory and immunosuppressive effects. They may be naturally produced (hormones) or synthetic (drugs). [NIH] Glucose: D-Glucose. A primary source of energy for living organisms. It is naturally occurring and is found in fruits and other parts of plants in its free state. It is used therapeutically in fluid and nutrient replacement. [NIH] Governing Board: The group in which legal authority is vested for the control of healthrelated institutions and organizations. [NIH] Growth: The progressive development of a living being or part of an organism from its earliest stage to maturity. [NIH] Headache: Pain in the cranial region that may occur as an isolated and benign symptom or as a manifestation of a wide variety of conditions including subarachnoid hemorrhage; craniocerebral trauma; central nervous system infections; intracranial hypertension; and other disorders. In general, recurrent headaches that are not associated with a primary disease process are referred to as headache disorders (e.g., migraine). [NIH] Hematocrit: Measurement of the volume of packed red cells in a blood specimen by centrifugation. The procedure is performed using a tube with graduated markings or with automated blood cell counters. It is used as an indicator of erythrocyte status in disease. For example, anemia shows a low hematocrit, polycythemia, high values. [NIH]

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Hemoglobin: One of the fractions of glycosylated hemoglobin A1c. Glycosylated hemoglobin is formed when linkages of glucose and related monosaccharides bind to hemoglobin A and its concentration represents the average blood glucose level over the previous several weeks. HbA1c levels are used as a measure of long-term control of plasma glucose (normal, 4 to 6 percent). In controlled diabetes mellitus, the concentration of glycosylated hemoglobin A is within the normal range, but in uncontrolled cases the level may be 3 to 4 times the normal conentration. Generally, complications are substantially lower among patients with Hb levels of 7 percent or less than in patients with HbA1c levels of 9 percent or more. [NIH] Hemorrhage: Bleeding or escape of blood from a vessel. [NIH] Hip Fractures: Fractures of the femur head, the femur neck, the trochanters, or the inter- or subtrochanteric region. Excludes fractures of the acetabulum and fractures of the femoral shaft below the subtrochanteric region. For the fractures of the femur neck the specific term femoral neck fractures is available. [NIH] Homeostasis: The processes whereby the internal environment of an organism tends to remain balanced and stable. [NIH] Hormonal: Pertaining to or of the nature of a hormone. [EU] Hormone: A substance in the body that regulates certain organs. Hormones such as gastrin help in breaking down food. Some hormones come from cells in the stomach and small intestine. [NIH] Hormone Replacement Therapy: Therapeutic use of hormones to alleviate the effects of hormone deficiency. [NIH] Hydroxylysine: A hydroxylated derivative of the amino acid lysine that is present in certain collagens. [NIH] Hydroxyproline: A hydroxylated form of the imino acid proline. A deficiency in ascorbic acid can result in impaired hydroxyproline formation. [NIH] Hypercalcemia: Abnormally high level of calcium in the blood. [NIH] Hypersensitivity: Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen. [NIH] Id: The part of the personality structure which harbors the unconscious instinctive desires and strivings of the individual. [NIH] Immune response: The activity of the immune system against foreign substances (antigens). [NIH]

Immunosuppressive: Describes the ability to lower immune system responses. [NIH] Impairment: In the context of health experience, an impairment is any loss or abnormality of psychological, physiological, or anatomical structure or function. [NIH] Implantation: The insertion or grafting into the body of biological, living, inert, or radioactive material. [EU] In situ: In the natural or normal place; confined to the site of origin without invasion of neighbouring tissues. [EU] Indigestion: Poor digestion. Symptoms include heartburn, nausea, bloating, and gas. Also called dyspepsia. [NIH] Infarction: A pathological process consisting of a sudden insufficient blood supply to an area, which results in necrosis of that area. It is usually caused by a thrombus, an embolus, or a vascular torsion. [NIH] Infection: 1. Invasion and multiplication of microorganisms in body tissues, which may be

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clinically unapparent or result in local cellular injury due to competitive metabolism, toxins, intracellular replication, or antigen-antibody response. The infection may remain localized, subclinical, and temporary if the body's defensive mechanisms are effective. A local infection may persist and spread by extension to become an acute, subacute, or chronic clinical infection or disease state. A local infection may also become systemic when the microorganisms gain access to the lymphatic or vascular system. 2. An infectious disease. [EU]

Inflammation: A pathological process characterized by injury or destruction of tissues caused by a variety of cytologic and chemical reactions. It is usually manifested by typical signs of pain, heat, redness, swelling, and loss of function. [NIH] Intermittent: Occurring at separated intervals; having periods of cessation of activity. [EU] Intestinal: Having to do with the intestines. [NIH] Intestines: The section of the alimentary canal from the stomach to the anus. It includes the large intestine and small intestine. [NIH] Intoxication: Poisoning, the state of being poisoned. [EU] Intracellular: Inside a cell. [NIH] Intravenous: IV. Into a vein. [NIH] Joint: The point of contact between elements of an animal skeleton with the parts that surround and support it. [NIH] Kb: A measure of the length of DNA fragments, 1 Kb = 1000 base pairs. The largest DNA fragments are up to 50 kilobases long. [NIH] Kinetic: Pertaining to or producing motion. [EU] Lactose Intolerance: The disease state resulting from the absence of lactase enzyme in the musocal cells of the gastrointestinal tract, and therefore an inability to break down the disaccharide lactose in milk for absorption from the gastrointestinal tract. It is manifested by indigestion of a mild nature to severe diarrhea. It may be due to inborn defect genetically conditioned or may be acquired. [NIH] Large Intestine: The part of the intestine that goes from the cecum to the rectum. The large intestine absorbs water from stool and changes it from a liquid to a solid form. The large intestine is 5 feet long and includes the appendix, cecum, colon, and rectum. Also called colon. [NIH] Larynx: An irregularly shaped, musculocartilaginous tubular structure, lined with mucous membrane, located at the top of the trachea and below the root of the tongue and the hyoid bone. It is the essential sphincter guarding the entrance into the trachea and functioning secondarily as the organ of voice. [NIH] Leukocytes: White blood cells. These include granular leukocytes (basophils, eosinophils, and neutrophils) as well as non-granular leukocytes (lymphocytes and monocytes). [NIH] Library Services: Services offered to the library user. They include reference and circulation. [NIH]

Life Expectancy: A figure representing the number of years, based on known statistics, to which any person of a given age may reasonably expect to live. [NIH] Ligament: A band of fibrous tissue that connects bones or cartilages, serving to support and strengthen joints. [EU] Liver: A large, glandular organ located in the upper abdomen. The liver cleanses the blood and aids in digestion by secreting bile. [NIH] Lumbar: Pertaining to the loins, the part of the back between the thorax and the pelvis. [EU]

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Lupus: A form of cutaneous tuberculosis. It is seen predominantly in women and typically involves the nasal, buccal, and conjunctival mucosa. [NIH] Malignant: Cancerous; a growth with a tendency to invade and destroy nearby tissue and spread to other parts of the body. [NIH] Malignant tumor: A tumor capable of metastasizing. [NIH] Mammary: Pertaining to the mamma, or breast. [EU] Mandible: The largest and strongest bone of the face constituting the lower jaw. It supports the lower teeth. [NIH] Medial: Lying near the midsaggital plane of the body; opposed to lateral. [NIH] MEDLINE: An online database of MEDLARS, the computerized bibliographic Medical Literature Analysis and Retrieval System of the National Library of Medicine. [NIH] Membrane: A very thin layer of tissue that covers a surface. [NIH] Menopause: Permanent cessation of menstruation. [NIH] Menstruation: The normal physiologic discharge through the vagina of blood and mucosal tissues from the nonpregnant uterus. [NIH] Mental: Pertaining to the mind; psychic. 2. (L. mentum chin) pertaining to the chin. [EU] Mental Disorders: Psychiatric illness or diseases manifested by breakdowns in the adaptational process expressed primarily as abnormalities of thought, feeling, and behavior producing either distress or impairment of function. [NIH] Metastasis: The spread of cancer from one part of the body to another. Tumors formed from cells that have spread are called "secondary tumors" and contain cells that are like those in the original (primary) tumor. The plural is metastases. [NIH] Metastatic: Having to do with metastasis, which is the spread of cancer from one part of the body to another. [NIH] MI: Myocardial infarction. Gross necrosis of the myocardium as a result of interruption of the blood supply to the area; it is almost always caused by atherosclerosis of the coronary arteries, upon which coronary thrombosis is usually superimposed. [NIH] Microbe: An organism which cannot be observed with the naked eye; e. g. unicellular animals, lower algae, lower fungi, bacteria. [NIH] Microorganism: An organism that can be seen only through a microscope. Microorganisms include bacteria, protozoa, algae, and fungi. Although viruses are not considered living organisms, they are sometimes classified as microorganisms. [NIH] Milligram: A measure of weight. A milligram is approximately 450,000-times smaller than a pound and 28,000-times smaller than an ounce. [NIH] Milliliter: A measure of volume for a liquid. A milliliter is approximately 950-times smaller than a quart and 30-times smaller than a fluid ounce. A milliliter of liquid and a cubic centimeter (cc) of liquid are the same. [NIH] Mineralization: The action of mineralizing; the state of being mineralized. [EU] Mineralocorticoids: A group of corticosteroids primarily associated with the regulation of water and electrolyte balance. This is accomplished through the effect on ion transport in renal tubules, resulting in retention of sodium and loss of potassium. Mineralocorticoid secretion is itself regulated by plasma volume, serum potassium, and angiotensin II. [NIH] Mobilization: The process of making a fixed part or stored substance mobile, as by separating a part from surrounding structures to make it accessible for an operative procedure or by causing release into the circulation for body use of a substance stored in the

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body. [EU] Modulator: A specific inductor that brings out characteristics peculiar to a definite region. [EU]

Molecular: Of, pertaining to, or composed of molecules : a very small mass of matter. [EU] Molecule: A chemical made up of two or more atoms. The atoms in a molecule can be the same (an oxygen molecule has two oxygen atoms) or different (a water molecule has two hydrogen atoms and one oxygen atom). Biological molecules, such as proteins and DNA, can be made up of many thousands of atoms. [NIH] Motion Sickness: Sickness caused by motion, as sea sickness, train sickness, car sickness, and air sickness. [NIH] Mucosa: A mucous membrane, or tunica mucosa. [EU] Multicenter study: A clinical trial that is carried out at more than one medical institution. [NIH]

Multiple Myeloma: A malignant tumor of plasma cells usually arising in the bone marrow; characterized by diffuse involvement of the skeletal system, hyperglobulinemia, Bence-Jones proteinuria, and anemia. [NIH] Myocardium: The muscle tissue of the heart composed of striated, involuntary muscle known as cardiac muscle. [NIH] Nausea: An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Common causes are early pregnancy, sea and motion sickness, emotional stress, intense pain, food poisoning, and various enteroviruses. [NIH] NCI: National Cancer Institute. NCI, part of the National Institutes of Health of the United States Department of Health and Human Services, is the federal government's principal agency for cancer research. NCI conducts, coordinates, and funds cancer research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer. Access the NCI Web site at http://cancer.gov. [NIH] Necrosis: A pathological process caused by the progressive degradative action of enzymes that is generally associated with severe cellular trauma. It is characterized by mitochondrial swelling, nuclear flocculation, uncontrolled cell lysis, and ultimately cell death. [NIH] Need: A state of tension or dissatisfaction felt by an individual that impels him to action toward a goal he believes will satisfy the impulse. [NIH] Nitrogen: An element with the atomic symbol N, atomic number 7, and atomic weight 14. Nitrogen exists as a diatomic gas and makes up about 78% of the earth's atmosphere by volume. It is a constituent of proteins and nucleic acids and found in all living cells. [NIH] Nucleic acid: Either of two types of macromolecule (DNA or RNA) formed by polymerization of nucleotides. Nucleic acids are found in all living cells and contain the information (genetic code) for the transfer of genetic information from one generation to the next. [NIH] Odour: A volatile emanation that is perceived by the sense of smell. [EU] Ointments: Semisolid preparations used topically for protective emollient effects or as a vehicle for local administration of medications. Ointment bases are various mixtures of fats, waxes, animal and plant oils and solid and liquid hydrocarbons. [NIH] Opacity: Degree of density (area most dense taken for reading). [NIH] Ossification: The formation of bone or of a bony substance; the conversion of fibrous tissue or of cartilage into bone or a bony substance. [EU] Osteoblasts: Bone-forming cells which secrete an extracellular matrix. Hydroxyapatite

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crystals are then deposited into the matrix to form bone. [NIH] Osteoclasts: A large multinuclear cell associated with the absorption and removal of bone. An odontoclast, also called cementoclast, is cytomorphologically the same as an osteoclast and is involved in cementum resorption. [NIH] Osteogenesis: The histogenesis of bone including ossification. It occurs continuously but particularly in the embryo and child and during fracture repair. [NIH] Osteogenesis Imperfecta: A collagen disorder resulting from defective biosynthesis of type I collagen and characterized by brittle, osteoporotic, and easily fractured bones. It may also present with blue sclerae, loose joints, and imperfect dentin formation. There are four major types, I-IV. [NIH] Osteoporosis: Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis and age-related (or senile) osteoporosis. [NIH] Osteotomy: The surgical cutting of a bone. [EU] Ovariectomy: The surgical removal of one or both ovaries. [NIH] Ovaries: The pair of female reproductive glands in which the ova, or eggs, are formed. The ovaries are located in the pelvis, one on each side of the uterus. [NIH] Palliative: 1. Affording relief, but not cure. 2. An alleviating medicine. [EU] Pamidronate: A drug that belongs to the family of drugs called bisphosphonates. Pamidronate is used as treatment for abnormally high levels of calcium in the blood. [NIH] Pancreas: A mixed exocrine and endocrine gland situated transversely across the posterior abdominal wall in the epigastric and hypochondriac regions. The endocrine portion is comprised of the Islets of Langerhans, while the exocrine portion is a compound acinar gland that secretes digestive enzymes. [NIH] Parathyroid: 1. Situated beside the thyroid gland. 2. One of the parathyroid glands. 3. A sterile preparation of the water-soluble principle(s) of the parathyroid glands, ad-ministered parenterally as an antihypocalcaemic, especially in the treatment of acute hypoparathyroidism with tetany. [EU] Parathyroid Glands: Two small paired endocrine glands in the region of the thyroid gland. They secrete parathyroid hormone and are concerned with the metabolism of calcium and phosphorus. [NIH] Parathyroid hormone: A substance made by the parathyroid gland that helps the body store and use calcium. Also called parathormone, parathyrin, or PTH. [NIH] Pathologic: 1. Indicative of or caused by a morbid condition. 2. Pertaining to pathology (= branch of medicine that treats the essential nature of the disease, especially the structural and functional changes in tissues and organs of the body caused by the disease). [EU] Patient Education: The teaching or training of patients concerning their own health needs. [NIH]

Pelvic: Pertaining to the pelvis. [EU] Pelvis: The lower part of the abdomen, located between the hip bones. [NIH] Peptide: Any compound consisting of two or more amino acids, the building blocks of proteins. Peptides are combined to make proteins. [NIH] Pericardium: The fibroserous sac surrounding the heart and the roots of the great vessels. [NIH]

Periodontal disease: Disease involving the supporting structures of the teeth (as the gums and periodontal membranes). [NIH]

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Periodontal disease: Disease involving the supporting structures of the teeth (as the gums and periodontal membranes). [NIH] PH: The symbol relating the hydrogen ion (H+) concentration or activity of a solution to that of a given standard solution. Numerically the pH is approximately equal to the negative logarithm of H+ concentration expressed in molarity. pH 7 is neutral; above it alkalinity increases and below it acidity increases. [EU] Pharmaceutical Preparations: Drugs intended for human or veterinary use, presented in their finished dosage form. Included here are materials used in the preparation and/or formulation of the finished dosage form. [NIH] Pharmaceutical Solutions: Homogeneous liquid preparations that contain one or more chemical substances dissolved, i.e., molecularly dispersed, in a suitable solvent or mixture of mutually miscible solvents. For reasons of their ingredients, method of preparation, or use, they do not fall into another group of products. [NIH] Pharmacokinetic: The mathematical analysis of the time courses of absorption, distribution, and elimination of drugs. [NIH] Pharmacologic: Pertaining to pharmacology or to the properties and reactions of drugs. [EU] Pharynx: The hollow tube about 5 inches long that starts behind the nose and ends at the top of the trachea (windpipe) and esophagus (the tube that goes to the stomach). [NIH] Phosphorus: A non-metallic element that is found in the blood, muscles, nevers, bones, and teeth, and is a component of adenosine triphosphate (ATP; the primary energy source for the body's cells.) [NIH] Physiologic: Having to do with the functions of the body. When used in the phrase "physiologic age," it refers to an age assigned by general health, as opposed to calendar age. [NIH]

Pituitary Gland: A small, unpaired gland situated in the sella turcica tissue. It is connected to the hypothalamus by a short stalk. [NIH] Plasma: The clear, yellowish, fluid part of the blood that carries the blood cells. The proteins that form blood clots are in plasma. [NIH] Plasma cells: A type of white blood cell that produces antibodies. [NIH] Plicamycin: A tricyclic pentaglycosidic antibiotic from Streptomyces strains that inhibits RNA and protein synthesis by adhering to DNA. It is used as a fluorescent dye and as an antineoplastic agent, especially in bone and testicular tumors. Plicamycin is also used to reduce hypercalcemia, especially that due to malignancies. [NIH] Poisoning: A condition or physical state produced by the ingestion, injection or inhalation of, or exposure to a deleterious agent. [NIH] Polymorphic: Occurring in several or many forms; appearing in different forms at different stages of development. [EU] Polypeptide: A peptide which on hydrolysis yields more than two amino acids; called tripeptides, tetrapeptides, etc. according to the number of amino acids contained. [EU] Polysaccharide: A type of carbohydrate. It contains sugar molecules that are linked together chemically. [NIH] Porosity: Condition of having pores or open spaces. This often refers to bones, bone implants, or bone cements, but can refer to the porous state of any solid substance. [NIH] Postmenopausal: Refers to the time after menopause. Menopause is the time in a woman's life when menstrual periods stop permanently; also called "change of life." [NIH] Practice Guidelines: Directions or principles presenting current or future rules of policy for

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the health care practitioner to assist him in patient care decisions regarding diagnosis, therapy, or related clinical circumstances. The guidelines may be developed by government agencies at any level, institutions, professional societies, governing boards, or by the convening of expert panels. The guidelines form a basis for the evaluation of all aspects of health care and delivery. [NIH] Preclinical: Before a disease becomes clinically recognizable. [EU] Premenopausal: Refers to the time before menopause. Menopause is the time of life when a women's menstrual periods stop permanently; also called "change of life." [NIH] Progressive: Advancing; going forward; going from bad to worse; increasing in scope or severity. [EU] Proline: A non-essential amino acid that is synthesized from glutamic acid. It is an essential component of collagen and is important for proper functioning of joints and tendons. [NIH] Proportional: Being in proportion : corresponding in size, degree, or intensity, having the same or a constant ratio; of, relating to, or used in determining proportions. [EU] Prospective Studies: Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. [NIH] Prostaglandin: Any of a group of components derived from unsaturated 20-carbon fatty acids, primarily arachidonic acid, via the cyclooxygenase pathway that are extremely potent mediators of a diverse group of physiologic processes. The abbreviation for prostaglandin is PG; specific compounds are designated by adding one of the letters A through I to indicate the type of substituents found on the hydrocarbon skeleton and a subscript (1, 2 or 3) to indicate the number of double bonds in the hydrocarbon skeleton e.g., PGE2. The predominant naturally occurring prostaglandins all have two double bonds and are synthesized from arachidonic acid (5,8,11,14-eicosatetraenoic acid) by the pathway shown in the illustration. The 1 series and 3 series are produced by the same pathway with fatty acids having one fewer double bond (8,11,14-eicosatrienoic acid or one more double bond (5,8,11,14,17-eicosapentaenoic acid) than arachidonic acid. The subscript a or ß indicates the configuration at C-9 (a denotes a substituent below the plane of the ring, ß, above the plane). The naturally occurring PGF's have the a configuration, e.g., PGF2a. All of the prostaglandins act by binding to specific cell-surface receptors causing an increase in the level of the intracellular second messenger cyclic AMP (and in some cases cyclic GMP also). The effect produced by the cyclic AMP increase depends on the specific cell type. In some cases there is also a positive feedback effect. Increased cyclic AMP increases prostaglandin synthesis leading to further increases in cyclic AMP. [EU] Prostaglandins A: (13E,15S)-15-Hydroxy-9-oxoprosta-10,13-dien-1-oic acid (PGA(1)); (5Z,13E,15S)-15-hydroxy-9-oxoprosta-5,10,13-trien-1-oic acid (PGA(2)); (5Z,13E,15S,17Z)-15hydroxy-9-oxoprosta-5,10,13,17-tetraen-1-oic acid (PGA(3)). A group of naturally occurring secondary prostaglandins derived from PGE. PGA(1) and PGA(2) as well as their 19hydroxy derivatives are found in many organs and tissues. [NIH] Prostate: A gland in males that surrounds the neck of the bladder and the urethra. It secretes a substance that liquifies coagulated semen. It is situated in the pelvic cavity behind the lower part of the pubic symphysis, above the deep layer of the triangular ligament, and rests upon the rectum. [NIH] Protein S: The vitamin K-dependent cofactor of activated protein C. Together with protein C, it inhibits the action of factors VIIIa and Va. A deficiency in protein S can lead to recurrent venous and arterial thrombosis. [NIH] Proteins: Polymers of amino acids linked by peptide bonds. The specific sequence of amino

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acids determines the shape and function of the protein. [NIH] Proteinuria: The presence of protein in the urine, indicating that the kidneys are not working properly. [NIH] Proximal: Nearest; closer to any point of reference; opposed to distal. [EU] Psychic: Pertaining to the psyche or to the mind; mental. [EU] Public Policy: A course or method of action selected, usually by a government, from among alternatives to guide and determine present and future decisions. [NIH] Radiation: Emission or propagation of electromagnetic energy (waves/rays), or the waves/rays themselves; a stream of electromagnetic particles (electrons, neutrons, protons, alpha particles) or a mixture of these. The most common source is the sun. [NIH] Radius: The lateral bone of the forearm. [NIH] Raloxifene: A second generation selective estrogen receptor modulator (SERM) used to prevent osteoporosis in postmenopausal women. It has estrogen agonist effects on bone and cholesterol metabolism but behaves as a complete estrogen antagonist on mammary gland and uterine tissue. [NIH] Random Allocation: A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects. [NIH] Randomization: Also called random allocation. Is allocation of individuals to groups, e.g., for experimental and control regimens, by chance. Within the limits of chance variation, random allocation should make the control and experimental groups similar at the start of an investigation and ensure that personal judgment and prejudices of the investigator do not influence allocation. [NIH] Randomized: Describes an experiment or clinical trial in which animal or human subjects are assigned by chance to separate groups that compare different treatments. [NIH] Receptor: A molecule inside or on the surface of a cell that binds to a specific substance and causes a specific physiologic effect in the cell. [NIH] Rectum: The last 8 to 10 inches of the large intestine. [NIH] Refer: To send or direct for treatment, aid, information, de decision. [NIH] Reflux: The term used when liquid backs up into the esophagus from the stomach. [NIH] Regimen: A treatment plan that specifies the dosage, the schedule, and the duration of treatment. [NIH] Resorption: The loss of substance through physiologic or pathologic means, such as loss of dentin and cementum of a tooth, or of the alveolar process of the mandible or maxilla. [EU] Retrospective: Looking back at events that have already taken place. [NIH] Rheumatism: A group of disorders marked by inflammation or pain in the connective tissue structures of the body. These structures include bone, cartilage, and fat. [NIH] Rheumatoid: Resembling rheumatism. [EU] Rheumatoid arthritis: A form of arthritis, the cause of which is unknown, although infection, hypersensitivity, hormone imbalance and psychologic stress have been suggested as possible causes. [NIH] Risk factor: A habit, trait, condition, or genetic alteration that increases a person's chance of developing a disease. [NIH] Salivary: The duct that convey saliva to the mouth. [NIH]

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Salivary glands: Glands in the mouth that produce saliva. [NIH] Schizoid: Having qualities resembling those found in greater degree in schizophrenics; a person of schizoid personality. [NIH] Schizophrenia: A mental disorder characterized by a special type of disintegration of the personality. [NIH] Schizotypal Personality Disorder: A personality disorder in which there are oddities of thought (magical thinking, paranoid ideation, suspiciousness), perception (illusions, depersonalization), speech (digressive, vague, overelaborate), and behavior (inappropriate affect in social interactions, frequently social isolation) that are not severe enough to characterize schizophrenia. [NIH] Sclerae: A circular furrow between the sclerocorneal junction and the iris. [NIH] Screening: Checking for disease when there are no symptoms. [NIH] Secretion: 1. The process of elaborating a specific product as a result of the activity of a gland; this activity may range from separating a specific substance of the blood to the elaboration of a new chemical substance. 2. Any substance produced by secretion. [EU] Seizures: Clinical or subclinical disturbances of cortical function due to a sudden, abnormal, excessive, and disorganized discharge of brain cells. Clinical manifestations include abnormal motor, sensory and psychic phenomena. Recurrent seizures are usually referred to as epilepsy or "seizure disorder." [NIH] Selective estrogen receptor modulator: SERM. A drug that acts like estrogen on some tissues, but blocks the effect of estrogen on other tissues. Tamoxifen and raloxifene are SERMs. [NIH] Semen: The thick, yellowish-white, viscid fluid secretion of male reproductive organs discharged upon ejaculation. In addition to reproductive organ secretions, it contains spermatozoa and their nutrient plasma. [NIH] Senile: Relating or belonging to old age; characteristic of old age; resulting from infirmity of old age. [NIH] Sequential treatment: One treatment after the other. [NIH] Serum: The clear liquid part of the blood that remains after blood cells and clotting proteins have been removed. [NIH] Sex Characteristics: Those characteristics that distinguish one sex from the other. The primary sex characteristics are the ovaries and testes and their related hormones. Secondary sex characteristics are those which are masculine or feminine but not directly related to reproduction. [NIH] Side effect: A consequence other than the one(s) for which an agent or measure is used, as the adverse effects produced by a drug, especially on a tissue or organ system other than the one sought to be benefited by its administration. [EU] Skeletal: Having to do with the skeleton (boney part of the body). [NIH] Skeleton: The framework that supports the soft tissues of vertebrate animals and protects many of their internal organs. The skeletons of vertebrates are made of bone and/or cartilage. [NIH] Skull: The skeleton of the head including the bones of the face and the bones enclosing the brain. [NIH] Small intestine: The part of the digestive tract that is located between the stomach and the large intestine. [NIH] Smooth muscle: Muscle that performs automatic tasks, such as constricting blood vessels.

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[NIH]

Sodium: An element that is a member of the alkali group of metals. It has the atomic symbol Na, atomic number 11, and atomic weight 23. With a valence of 1, it has a strong affinity for oxygen and other nonmetallic elements. Sodium provides the chief cation of the extracellular body fluids. Its salts are the most widely used in medicine. (From Dorland, 27th ed) Physiologically the sodium ion plays a major role in blood pressure regulation, maintenance of fluid volume, and electrolyte balance. [NIH] Soft tissue: Refers to muscle, fat, fibrous tissue, blood vessels, or other supporting tissue of the body. [NIH] Specialist: In medicine, one who concentrates on 1 special branch of medical science. [NIH] Sphincter: A ringlike band of muscle fibres that constricts a passage or closes a natural orifice; called also musculus sphincter. [EU] Stabilization: The creation of a stable state. [EU] Sterile: Unable to produce children. [NIH] Steroids: Drugs used to relieve swelling and inflammation. [NIH] Stimulant: 1. Producing stimulation; especially producing stimulation by causing tension on muscle fibre through the nervous tissue. 2. An agent or remedy that produces stimulation. [EU]

Stomach: An organ of digestion situated in the left upper quadrant of the abdomen between the termination of the esophagus and the beginning of the duodenum. [NIH] Stress: Forcibly exerted influence; pressure. Any condition or situation that causes strain or tension. Stress may be either physical or psychologic, or both. [NIH] Stricture: The abnormal narrowing of a body opening. Also called stenosis. [NIH] Stroke: Sudden loss of function of part of the brain because of loss of blood flow. Stroke may be caused by a clot (thrombosis) or rupture (hemorrhage) of a blood vessel to the brain. [NIH] Subtrochanteric: Below a trochanter. [NIH] Supplementation: Adding nutrients to the diet. [NIH] Suppositories: A small cone-shaped medicament having cocoa butter or gelatin at its basis and usually intended for the treatment of local conditions in the rectum. [NIH] Suppression: A conscious exclusion of disapproved desire contrary with repression, in which the process of exclusion is not conscious. [NIH] Symphysis: A secondary cartilaginous joint. [NIH] Symptomatic: Having to do with symptoms, which are signs of a condition or disease. [NIH] Synergistic: Acting together; enhancing the effect of another force or agent. [EU] Systemic: Affecting the entire body. [NIH] Systemic lupus erythematosus: SLE. A chronic inflammatory connective tissue disease marked by skin rashes, joint pain and swelling, inflammation of the kidneys, inflammation of the fibrous tissue surrounding the heart (i.e., the pericardium), as well as other problems. Not all affected individuals display all of these problems. May be referred to as lupus. [NIH] Talus: The second largest of the tarsal bones and occupies the middle and upper part of the tarsus. [NIH] Tamoxifen: A first generation selective estrogen receptor modulator (SERM). It acts as an agonist for bone tissue and cholesterol metabolism but is an estrogen antagonist in mammary and uterine. [NIH]

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Testicular: Pertaining to a testis. [EU] Testosterone: A hormone that promotes the development and maintenance of male sex characteristics. [NIH] Tetany: 1. Hyperexcitability of nerves and muscles due to decrease in concentration of extracellular ionized calcium, which may be associated with such conditions as parathyroid hypofunction, vitamin D deficiency, and alkalosis or result from ingestion of alkaline salts; it is characterized by carpopedal spasm, muscular twitching and cramps, laryngospasm with inspiratory stridor, hyperreflexia and choreiform movements. 2. Tetanus. [EU] Therapeutics: The branch of medicine which is concerned with the treatment of diseases, palliative or curative. [NIH] Thigh: A leg; in anatomy, any elongated process or part of a structure more or less comparable to a leg. [NIH] Thorax: A part of the trunk between the neck and the abdomen; the chest. [NIH] Thrombosis: The formation or presence of a blood clot inside a blood vessel. [NIH] Thyroid: A gland located near the windpipe (trachea) that produces thyroid hormone, which helps regulate growth and metabolism. [NIH] Thyroid Gland: A highly vascular endocrine gland consisting of two lobes, one on either side of the trachea, joined by a narrow isthmus; it produces the thyroid hormones which are concerned in regulating the metabolic rate of the body. [NIH] Tibia: The second longest bone of the skeleton. It is located on the medial side of the lower leg, articulating with the fibula laterally, the talus distally, and the femur proximally. [NIH] Tissue: A group or layer of cells that are alike in type and work together to perform a specific function. [NIH] Tomography: Imaging methods that result in sharp images of objects located on a chosen plane and blurred images located above or below the plane. [NIH] Tooth Movement: Orthodontic techniques used to correct the malposition of a single tooth. [NIH]

Topical: On the surface of the body. [NIH] Toxic: Having to do with poison or something harmful to the body. Toxic substances usually cause unwanted side effects. [NIH] Toxicity: The quality of being poisonous, especially the degree of virulence of a toxic microbe or of a poison. [EU] Toxicokinetics: Study of the absorption, distribution, metabolism, and excretion of test substances. [NIH] Toxicology: The science concerned with the detection, chemical composition, and pharmacologic action of toxic substances or poisons and the treatment and prevention of toxic manifestations. [NIH] Trachea: The cartilaginous and membranous tube descending from the larynx and branching into the right and left main bronchi. [NIH] Transfection: The uptake of naked or purified DNA into cells, usually eukaryotic. It is analogous to bacterial transformation. [NIH] Trauma: Any injury, wound, or shock, must frequently physical or structural shock, producing a disturbance. [NIH] Tricyclic: Containing three fused rings or closed chains in the molecular structure. [EU] Tryptophan: An essential amino acid that is necessary for normal growth in infants and for

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nitrogen balance in adults. It is a precursor serotonin and niacin. [NIH] Tuberculosis: Any of the infectious diseases of man and other animals caused by species of Mycobacterium. [NIH] Ulcer: A localized necrotic lesion of the skin or a mucous surface. [NIH] Ulceration: 1. The formation or development of an ulcer. 2. An ulcer. [EU] Ulcerogenic: Causing ulceration; leading to the production of ulcers. [EU] Unconscious: Experience which was once conscious, but was subsequently rejected, as the "personal unconscious". [NIH] Urethra: The tube through which urine leaves the body. It empties urine from the bladder. [NIH]

Urinary: Having to do with urine or the organs of the body that produce and get rid of urine. [NIH] Urine: Fluid containing water and waste products. Urine is made by the kidneys, stored in the bladder, and leaves the body through the urethra. [NIH] Vein: Vessel-carrying blood from various parts of the body to the heart. [NIH] Venous: Of or pertaining to the veins. [EU] Venous blood: Blood that has given up its oxygen to the tissues and carries carbon dioxide back for gas exchange. [NIH] Vertebrae: A bony unit of the segmented spinal column. [NIH] Vertebral: Of or pertaining to a vertebra. [EU] Veterinary Medicine: The medical science concerned with the prevention, diagnosis, and treatment of diseases in animals. [NIH] Virulence: The degree of pathogenicity within a group or species of microorganisms or viruses as indicated by case fatality rates and/or the ability of the organism to invade the tissues of the host. [NIH] Vitro: Descriptive of an event or enzyme reaction under experimental investigation occurring outside a living organism. Parts of an organism or microorganism are used together with artificial substrates and/or conditions. [NIH] Weight-Bearing: The physical state of supporting an applied load. This often refers to the weight-bearing bones or joints that support the body's weight, especially those in the spine, hip, knee, and foot. [NIH] Windpipe: A rigid tube, 10 cm long, extending from the cricoid cartilage to the upper border of the fifth thoracic vertebra. [NIH] Withdrawal: 1. A pathological retreat from interpersonal contact and social involvement, as may occur in schizophrenia, depression, or schizoid avoidant and schizotypal personality disorders. 2. (DSM III-R) A substance-specific organic brain syndrome that follows the cessation of use or reduction in intake of a psychoactive substance that had been regularly used to induce a state of intoxication. [EU] X-ray: High-energy radiation used in low doses to diagnose diseases and in high doses to treat cancer. [NIH] Zoledronate: A drug that belongs to the family of drugs called bisphosphonates. It is used to prevent bone fractures and reduce bone pain in people who have cancer that has spread to the bone. [NIH] Zygote: The fertilized ovum. [NIH]

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91

INDEX A Abdomen, 69, 72, 79, 82, 87, 88 Abdominal, 36, 69, 82 Abdominal Pain, 36, 69 Ablation, 29, 69 Adenosine, 69, 72, 83 Adjuvant, 69, 77 Adrenal Cortex, 69, 74 Adverse Effect, 69, 86 Affinity, 69, 87 Agonist, 69, 85, 87 Alendronate, 3, 4, 6, 9, 10, 11, 13, 15, 19, 21, 39, 42, 43, 56, 69 Alertness, 69, 72 Algorithms, 69, 71 Alkaline, 4, 69, 72, 88 Alkaline Phosphatase, 4, 69 Alternative medicine, 41, 69 Alveolar Bone Loss, 35, 70 Alveolar Process, 70, 85 Ampulla, 70, 75 Anabolic, 7, 14, 25, 26, 70 Analgesics, 5, 70 Androgens, 69, 70, 74 Anemia, 70, 77, 81 Anesthesia, 70 Antagonism, 70, 72 Antiallergic, 70, 74 Antibiotic, 70, 83 Anticonvulsants, 43, 70 Anti-inflammatory, 70, 74, 77 Anti-Inflammatory Agents, 70, 74 Antineoplastic, 70, 74, 83 Arachidonic Acid, 70, 84 Aromatic, 35, 70 Arteries, 70, 71, 74, 80 Ascorbic Acid, 70, 78 Aspirin, 14, 70 Asymptomatic, 4, 71 B Bacteria, 70, 71, 76, 80 Base, 71, 74, 76, 79 Biochemical, 6, 20, 71 Biosynthesis, 70, 71, 82 Biotechnology, 8, 41, 51, 71 Biotransformation, 71 Bladder, 71, 84, 89 Blastocyst, 71, 73

Blood Cell Count, 56, 71, 77 Blood Coagulation, 71, 72 Blood pressure, 71, 87 Blood vessel, 71, 73, 86, 87, 88 Body Composition, 6, 71 Body Fluids, 71, 87 Body Mass Index, 7, 71 Bone Cements, 71, 83 Bone Density, 5, 12, 17, 25, 26, 37, 43, 56, 72 Bone Marrow, 7, 72, 81 Bone Remodeling, 4, 12, 20, 24, 72 Bone Resorption, 11, 15, 35, 42, 56, 72 Bowel, 72, 75 Bowel Movement, 72, 75 Branch, 65, 72, 82, 87, 88 Buccal, 34, 35, 36, 72, 80 C Caffeine, 42, 72 Calcitonin, 5, 72 Calcium, 4, 5, 6, 7, 9, 24, 28, 29, 30, 34, 36, 42, 43, 72, 76, 78, 82, 88 Capsules, 72, 75, 77 Carbohydrate, 72, 74, 83 Cardiac, 72, 73, 81 Cell, 56, 69, 71, 73, 76, 79, 81, 82, 83, 84, 85 Cell Count, 56, 73 Cellobiose, 73 Cellulose, 13, 73 Central Nervous System, 72, 73, 77 Chemotherapy, 7, 10, 30, 73 Chin, 73, 80 Cholesterol, 73, 85, 87 Chronic, 73, 76, 79, 87 Clinical trial, 5, 6, 10, 16, 21, 29, 30, 51, 73, 74, 75, 81, 85 Cloning, 71, 73 Collagen, 4, 11, 24, 73, 77, 82, 84 Computational Biology, 51, 73 Conception, 56, 73 Connective Tissue, 70, 72, 73, 74, 77, 85, 87 Consciousness, 70, 74 Consumption, 42, 74 Contraindications, ii, 74 Controlled study, 10, 11, 74 Coronary, 74, 80 Coronary Thrombosis, 74, 80 Cortex, 74

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Cortical, 12, 14, 24, 25, 56, 74, 86 Corticosteroid, 12, 13, 16, 17, 18, 25, 26, 40, 74 Curative, 74, 88 Cutaneous, 74, 80 Cyclic, 72, 74, 84 D Databases, Bibliographic, 51, 74 Density, 5, 6, 7, 9, 10, 11, 15, 17, 24, 25, 26, 37, 43, 56, 71, 72, 74, 81 Deprivation, 6, 74 Diagnostic Imaging, 4, 74 Diagnostic procedure, 33, 41, 74 Diarrhea, 36, 74, 79 Digestion, 72, 74, 78, 79, 87 Digestive system, 31, 74 Direct, iii, 11, 24, 34, 36, 45, 75, 85 Discrete, 5, 72, 75 Distal, 75, 85 Diuresis, 72, 75 Dosage Forms, 34, 35, 36, 75 Double-blind, 6, 9, 10, 18, 26, 75 Drug Interactions, 46, 75 Duodenum, 75, 77, 87 E Eating Disorders, 4, 75 Efficacy, 6, 7, 13, 14, 15, 21, 22, 25, 26, 75 Elastin, 73, 75 Electrolyte, 74, 75, 80, 87 Embryo, 71, 75, 82 Endoscope, 75 Endoscopic, 4, 10, 13, 15, 75 Endoscopy, 9, 14, 75 Enteric-coated, 34, 35, 36, 75 Environmental Health, 50, 52, 75 Enzymatic, 72, 75 Enzyme, 69, 75, 79, 89 Epithelial, 34, 35, 36, 75 Erythrocyte Indices, 71, 76 Erythrocytes, 70, 71, 72, 76 Esophageal, 3, 13, 14, 21, 34, 36, 56, 76 Esophageal Stricture, 3, 76 Esophagitis, 3, 34, 35, 76 Esophagus, 34, 35, 36, 75, 76, 83, 85, 87 Estrogen, 4, 6, 7, 8, 11, 24, 29, 76, 85, 86, 87 Estrogen receptor, 6, 7, 76 Estrogen receptor positive, 7, 76 Etidronate, 4, 9, 11, 24, 37, 40, 76 Evacuation, 76, 77 Excipients, 34, 35, 76 Exogenous, 71, 76 Extracellular, 73, 74, 76, 81, 87, 88

Extracellular Matrix, 73, 74, 76, 81 F Family Planning, 51, 76 Fat, 70, 71, 72, 74, 76, 85, 87 Fatty acids, 76, 84 Femoral, 8, 76, 78 Femoral Neck Fractures, 76, 78 Femur, 4, 76, 78, 88 Fibula, 77, 88 Fistula, 77 Forearm, 7, 71, 77, 85 G Gallbladder, 69, 75, 77 Gas, 77, 78, 81, 89 Gastric, 4, 14, 39, 56, 75, 77 Gastric Emptying, 14, 77 Gastrin, 77, 78 Gastroduodenal, 13, 77 Gastrointestinal, 3, 4, 9, 10, 16, 21, 34, 36, 57, 77, 79 Gastrointestinal tract, 9, 21, 34, 77, 79 Gelatin, 13, 77, 87 Gene, 71, 77 Gland, 69, 77, 82, 83, 84, 85, 86, 88 Glucocorticoid, 15, 42, 58, 77 Glucose, 70, 73, 77, 78 Governing Board, 77, 84 Growth, 56, 70, 77, 80, 88 H Headache, 72, 77 Hematocrit, 71, 76, 77 Hemoglobin, 70, 71, 76, 78 Hemorrhage, 77, 78, 87 Hip Fractures, 17, 76, 78 Homeostasis, 9, 24, 72, 78 Hormonal, 74, 78 Hormone, 6, 7, 11, 24, 42, 56, 72, 74, 76, 77, 78, 85, 88 Hormone Replacement Therapy, 6, 7, 42, 56, 78 Hydroxylysine, 73, 78 Hydroxyproline, 4, 73, 78 Hypercalcemia, 76, 78, 83 Hypersensitivity, 78, 85 I Id, 27, 57, 58, 59, 64, 66, 78 Immune response, 69, 74, 78 Immunosuppressive, 77, 78 Impairment, 78, 80 Implantation, 73, 78 In situ, 7, 78 Indigestion, 78, 79

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Infarction, 74, 78, 80 Infection, 78, 85 Inflammation, 70, 76, 79, 85, 87 Intermittent, 12, 14, 24, 25, 79 Intestinal, 35, 36, 79 Intestines, 69, 75, 77, 79 Intoxication, 79, 89 Intracellular, 72, 79, 84 Intravenous, 17, 79 J Joint, 25, 79, 87 K Kb, 50, 79 Kinetic, 20, 79 L Lactose Intolerance, 4, 79 Large Intestine, 75, 79, 85, 86 Larynx, 34, 36, 79, 88 Leukocytes, 71, 72, 79 Library Services, 64, 79 Life Expectancy, 6, 79 Ligament, 79, 84 Liver, 69, 70, 75, 77, 79 Lumbar, 8, 9, 24, 79 Lupus, 42, 80, 87 M Malignant, 70, 80, 81 Malignant tumor, 80, 81 Mammary, 80, 85, 87 Mandible, 70, 73, 80, 85 Medial, 80, 88 MEDLINE, 51, 80 Membrane, 76, 79, 80, 81 Menopause, 7, 10, 40, 57, 80, 83, 84 Menstruation, 80 Mental, iv, 5, 31, 50, 52, 73, 80, 85, 86 Mental Disorders, 31, 80 Metastasis, 80 Metastatic, 10, 80 MI, 7, 67, 80 Microbe, 80, 88 Microorganism, 80, 89 Milligram, 4, 80 Milliliter, 72, 80 Mineralization, 36, 80 Mineralocorticoids, 69, 74, 80 Mobilization, 34, 36, 80 Modulator, 6, 81 Molecular, 51, 53, 71, 73, 81, 88 Molecule, 71, 76, 81, 85 Motion Sickness, 81 Mucosa, 80, 81

Multicenter study, 16, 81 Multiple Myeloma, 10, 13, 81 Myocardium, 80, 81 N Nausea, 36, 75, 78, 81 NCI, 1, 29, 30, 49, 81 Necrosis, 78, 80, 81 Need, 3, 9, 35, 42, 60, 76, 81 Nitrogen, 35, 70, 81, 89 Nucleic acid, 81 O Odour, 70, 81 Ointments, 75, 81 Opacity, 74, 81 Ossification, 81, 82 Osteoblasts, 42, 81 Osteoclasts, 72, 82 Osteogenesis, 56, 82 Osteogenesis Imperfecta, 56, 82 Osteoporosis, 3, 4, 5, 6, 7, 8, 24, 25, 26, 29, 30, 36, 40, 41, 42, 43, 56, 57, 58 Osteotomy, 56, 82 Ovariectomy, 11, 24, 82 Ovaries, 82, 86 P Palliative, 82, 88 Pamidronate, 5, 37, 42, 56, 82 Pancreas, 69, 75, 82 Parathyroid, 11, 24, 82, 88 Parathyroid Glands, 82 Parathyroid hormone, 11, 24, 82 Pathologic, 74, 78, 82, 85 Patient Education, 56, 62, 64, 67, 82 Pelvic, 82, 84 Pelvis, 4, 69, 79, 82 Peptide, 72, 82, 83, 84 Pericardium, 82, 87 Periodontal disease, 35, 70, 82, 83 PH, 72, 83 Pharmaceutical Preparations, 73, 77, 83 Pharmaceutical Solutions, 75, 83 Pharmacokinetic, 83 Pharmacologic, 70, 83, 88 Pharynx, 34, 35, 36, 83 Phosphorus, 72, 82, 83 Physiologic, 69, 71, 74, 80, 83, 84, 85 Pituitary Gland, 74, 83 Plasma, 72, 77, 78, 80, 81, 83, 86 Plasma cells, 81, 83 Plicamycin, 5, 83 Poisoning, 79, 81, 83 Polymorphic, 36, 83

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Polypeptide, 73, 83 Polysaccharide, 73, 83 Porosity, 56, 83 Postmenopausal, 4, 24, 25, 26, 40, 41, 43, 57, 58 Practice Guidelines, 52, 57, 83 Preclinical, 7, 84 Premenopausal, 30, 84 Progressive, 36, 77, 81, 84 Proline, 73, 78, 84 Proportional, 11, 84 Prospective Studies, 37, 84 Prostaglandin, 12, 13, 14, 24, 25, 26, 84 Prostaglandins A, 84 Prostate, 6, 29, 84 Protein S, 71, 83, 84 Proteins, 73, 81, 82, 83, 84, 86 Proteinuria, 81, 85 Proximal, 8, 25, 75, 85 Psychic, 80, 85, 86 Public Policy, 51, 85 R Radiation, 85, 89 Radius, 7, 85 Raloxifene, 6, 43, 85, 86 Random Allocation, 85 Randomization, 6, 85 Randomized, 6, 9, 13, 14, 15, 18, 24, 25, 75, 85 Receptor, 7, 76, 85 Rectum, 72, 75, 77, 79, 84, 85, 87 Refer, 1, 72, 83, 85 Reflux, 14, 85 Regimen, 20, 26, 75, 85 Resorption, 35, 36, 42, 56, 70, 72, 82, 85 Retrospective, 10, 85 Rheumatism, 16, 18, 85 Rheumatoid, 15, 85 Rheumatoid arthritis, 15, 85 Risk factor, 4, 43, 85 S Salivary, 75, 85, 86 Salivary glands, 75, 86 Schizoid, 86, 89 Schizophrenia, 86, 89 Schizotypal Personality Disorder, 86, 89 Sclerae, 82, 86 Screening, 58, 73, 86 Secretion, 74, 80, 86 Seizures, 70, 86 Selective estrogen receptor modulator, 6, 85, 86, 87

Semen, 84, 86 Senile, 82, 86 Sequential treatment, 7, 86 Serum, 4, 11, 24, 80, 86 Sex Characteristics, 70, 86, 88 Side effect, 5, 42, 45, 56, 69, 86, 88 Skeletal, 8, 20, 70, 81, 86 Skeleton, 7, 72, 76, 79, 84, 86, 88 Skull, 4, 86 Small intestine, 75, 78, 79, 86 Smooth muscle, 72, 86 Sodium, 20, 36, 72, 80, 87 Soft tissue, 72, 86, 87 Specialist, 59, 87 Sphincter, 79, 87 Stabilization, 35, 87 Sterile, 82, 87 Steroids, 42, 74, 77, 87 Stimulant, 72, 87 Stomach, 4, 34, 35, 69, 75, 76, 77, 78, 79, 81, 83, 85, 86, 87 Stress, 81, 85, 87 Stricture, 4, 87 Stroke, 31, 50, 87 Subtrochanteric, 78, 87 Supplementation, 6, 37, 87 Suppositories, 77, 87 Suppression, 74, 87 Symphysis, 73, 84, 87 Symptomatic, 4, 87 Synergistic, 4, 87 Systemic, 42, 46, 71, 79, 87 Systemic lupus erythematosus, 42, 87 T Talus, 87, 88 Tamoxifen, 7, 86, 87 Testicular, 83, 88 Testosterone, 6, 88 Tetany, 82, 88 Therapeutics, 14, 19, 25, 46, 88 Thigh, 76, 88 Thorax, 69, 79, 88 Thrombosis, 84, 87, 88 Thyroid, 72, 82, 88 Thyroid Gland, 82, 88 Tibia, 4, 77, 88 Tissue, 8, 12, 17, 18, 21, 25, 26, 34, 36, 72, 73, 74, 76, 79, 80, 81, 83, 85, 86, 87, 88 Tomography, 72, 88 Tooth Movement, 35, 88 Topical, 4, 88 Toxic, iv, 88

95

Toxicity, 9, 75, 88 Toxicokinetics, 88 Toxicology, 10, 52, 88 Trachea, 79, 83, 88 Transfection, 71, 88 Trauma, 76, 77, 81, 88 Tricyclic, 83, 88 Tryptophan, 73, 88 Tuberculosis, 74, 80, 89 U Ulcer, 89 Ulceration, 34, 35, 36, 89 Ulcerogenic, 4, 89 Unconscious, 78, 89 Urethra, 84, 89 Urinary, 4, 11, 24, 36, 89 Urine, 71, 75, 85, 89

V Vein, 79, 89 Venous, 71, 84, 89 Venous blood, 71, 89 Vertebrae, 11, 24, 89 Vertebral, 8, 12, 13, 15, 17, 18, 25, 26, 89 Veterinary Medicine, 51, 89 Virulence, 88, 89 Vitro, 21, 89 W Weight-Bearing, 43, 89 Windpipe, 83, 88, 89 Withdrawal, 13, 25, 26, 89 X X-ray, 4, 43, 72, 89 Z Zoledronate, 56, 89 Zygote, 73, 89

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