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Clinical Trials in Osteoporosis by Derek Pearson,Colin G. Miller Pdf
Clinical Trials in Osteoporosis is a practical handbook on clinical trials in the growing field of osteoporosis. Topics covered include study design, technical issues, data collection, quality assurance, data analysis and presentation. It aims to take the user through the process step-by-step from start to finish, also providing a background on regulatory guidelines, ethical implications, endpoints, current therapies and the ideal drug to use. There are no other books at present that specifically address the issue of clinical trials in osteoporosis. A number of issues dealt with in this book have been brought together in one publication for the first time. Clinical Trials in Osteoporosis is intended to serve as a practical manual for clinicians and scientists coming to the subject new and to provide a standard for existing centers to measure themselves against.
Guidelines for Preclinical Evaluation and Clinical Trials in Osteoporosis by World Health Organization Pdf
This book provides comprehensive guidelines for the design, implementation, and interpretation of preclinical studies and clinical trials of agents undergoing investigation for the management of osteoporosis. Noting the magnitude of the public health problem caused by osteoporosis and related fractures, the book responds to the urgent need for a cohesive and rational approach to the search for new therapeutic or preventive agents. Recommended principles and methods reflect the consensus reached by a large number of international experts, representatives of the pharmaceutical industry, and drug regulatory authorities. The book opens with a brief discussion of the current and future public health problem caused by osteoporotic fractures, followed by conceptual and operational definitions of osteoporosis and a recommended classification of four intervention categories that facilitate the definition of treatment objectives and the design of targetted studies. Against this background, the next chapter offers a detailed guide to the aims, design, conduct and interpretation of preclinical studies. Specific recommendations are given for the selection of in vitro and animal models, the design of the study, including dose ranges and duration of treatment, and the most appropriate end-points for assessing efficacy. The most extensive chapter provides a comprehensive description of basic principles and methods to follow during clinical trials. Information ranges from a discussion of problems with the use of bone mineral density to predict fracture risk, through advice on the choice of tests and techniques for measuring the effects of interventions, to a discussion of general principles of trial design, including selection of study population, treatment regimen, duration of studies, sample size, and frequency of measurement. Drawing on these detailed principles and methods, subsequent chapters offer concise guidance specific to phase I and phase II studies, phase III studies in severe osteoporosis, phase III studies in osteoporosis without fragility fractures, and phase III studies in osteopenia. The book concludes with chapters outlining principles and methods for phase III clinical trials in subjects with normal bone mass, and for phase IV studies.
Osteoporosis in Men by Eric S. Orwoll,John P. Bilezikian,Dirk Vanderschueren Pdf
Since the publication of the first edition, the U.S. Surgeon General released the first-ever report on bone health and osteoporosis in October 2004. This report focuses even more attention on the devastating impact osteoporosis has on millions of lives. According to the National Osteoporosis Foundation, 2 million American men have osteoporosis, and another 12 million are at risk for this disease. Yet despite the large number of men affected, the lack of awareness by doctors and their patients puts men at a higher risk that the condition may go undiagnosed and untreated. It is estimated that one-fifth to one-third of all hip fractures occur in men. This second edition brings on board John Bilezikian and Dirk Vanderschueren as editors with Eric Orwoll. The table of contents is more than doubling with 58 planned chapters. The format is larger – 8.5 x 11. This edition of Osteoporosis in Men brings together even more eminent investigators and clinicians to interpret developments in this growing field, and describe state-of-the-art research as well as practical approaches to diagnosis, prevention and therapy. Brings together more eminent investigators and clinicians to interpret developments in this growing field Describes state-of-the-art research as well as practical approaches to diagnosis, prevention and therapy There is no book on the market that covers osteoporosis in men as comprehensively as this book
Prevention and Treatment of Osteoporosis in the High-Risk Patient by Cyrus Cooper,Stephen H. Gehlbach,Robert Lindsay Pdf
The outcome of recent clinical trials in osteoporosis was the impetus for this volume. In these studies of two bisphosphonates, an interaction between bone mineral density (BMD) and the treatment effect was seen, such that these agents appeared to lose their effect as BMD increased. To practitioners this is counter-intuitive. Why should treatment w
Osteoporosis by Steven R. Cummings,Felicia Cosman,Sophie A. Jamal Pdf
Until recently considered an inevitable part of aging, osteoporosis is typically diagnosed only after a serious complication such as a fracture. It is now possible, however, to diagnose high-risk patients beforehand. Easily performed noninvasive tests estimate bone mass, and patients at risk can be treated with new drugs whose efficacy for fracture reduction has been proven in clinical trials. Osteoporosis: An Evidence-Based Guide to Prevention and Management, the newest volume in the acclaimed ACP Women's Health series, addresses every important facet of this common disease. The latest scientific evidence and the extensive clinical experience of the authors provide essential information on the origins and progress of osteoporosis. Treatment options are thoroughly reviewed.
United States. Food and Drug Administration. Division of Metabolism and Endocrine Drug Products
Author : United States. Food and Drug Administration. Division of Metabolism and Endocrine Drug Products Publisher : Unknown Page : 16 pages File Size : 46,5 Mb Release : 1979 Category : Drugs ISBN : MINN:31951003056736G
Guidelines for the Clinical Evaluation of Drugs Used in the Treatment of Osteoporosis by United States. Food and Drug Administration. Division of Metabolism and Endocrine Drug Products Pdf
United States Public Health Service,Surgeon General of the United States
Author : United States Public Health Service,Surgeon General of the United States Publisher : Unknown Page : 0 pages File Size : 50,5 Mb Release : 2004-12 Category : Health & Fitness ISBN : 1410219275
Bone Health and Osteoporosis by United States Public Health Service,Surgeon General of the United States Pdf
This first-ever Surgeon General's Report on bone health and osteoporosis illustrates the large burden that bone disease places on our Nation and its citizens. Like other chronic diseases that disproportionately affect the elderly, the prevalence of bone disease and fractures is projected to increase markedly as the population ages. If these predictions come true, bone disease and fractures will have a tremendous negative impact on the future well-being of Americans. But as this report makes clear, they need not come true: by working together we can change the picture of aging in America. Osteoporosis, fractures, and other chronic diseases no longer should be thought of as an inevitable part of growing old. By focusing on prevention and lifestyle changes, including physical activity and nutrition, as well as early diagnosis and appropriate treatment, Americans can avoid much of the damaging impact of bone disease and other chronic diseases. This Surgeon General's Report brings together for the first time the scientific evidence related to the prevention, assessment, diagnosis, and treatment of bone disease. More importantly, it provides a framework for moving forward. The report will be another effective tool in educating Americans about how they can promote bone health throughout their lives. This first-ever Surgeon General's Report on bone health and osteoporosis provides much needed information on bone health, an often overlooked aspect of physical health. This report follows in the tradition of previous Surgeon Generals' reports by identifying the relevant scientific data, rigorously evaluating and summarizing the evidence, and determining conclusions.
The Duration and Safety of Osteoporosis Treatment by Stuart Silverman,Bo Abrahamsen Pdf
Providing a comprehensive review of short-and long-term adverse events of both antiresorptive and anabolic drugs, this practical guide updates the clinician on the pathophysiology of osteoporosis and the principles behind our present and future pharmaceuticals. Leading practitioners in the field examine all current literature and data regarding the duration and safety of these therapies, with recommendations for clinicians on decision-making and best practices for osteoporosis patients. An overview of the pathophysiology and epidemiology of osteoporosis and discussion of both anabolic and antiresorptive drugs is followed by fracture risk assessment and an examination of treatment failures. Next, a number of chapters are dedicated to the diagnosis, presentation and management of atypical femur fractures and osteonecrosis of the jaw (ONJ), each of which are significant patient concerns when using these osteoporosis treatments. The introduction and utilization of drug holidays is also discussed, as well as the long-term outlook for management of osteoporotic patients. Written and edited by experts in the field, The Duration and Safety of Osteoporosis Treatment is a balanced resource for researchers, practitioners and policy-makers alike for clinical decision-making and patient care.
Osteoporosis by Robert Marcus,David Feldman,Dorothy Nelson,Clifford Rosen Pdf
Now in its third edition, Osteoporosis, is the most comprehensive, authoritative reference on this disease. Written by renowned experts in the field, this two-volume reference is a must-have for academic and medical libraries, physicians, researchers, and any company involved in osteoporosis research and development. Worldwide, 200 million women between 60-80 suffer from osteoporosis and have a lifetime risk of fracture between 30 and 40 percent continuing to make osteoporosis a hot topic in medicine. This newest edition covers everything from basic anatomy and physiology to diagnosis, management and treatment in a field where direct care costs for osteoporitic fractures in the U.S. reach up to $18 billion each year. NEW TO THIS EDITION: *Recognizes the critical importance of the Wnt signaling pathway for bone health *Incorporates new chapters on osteocytes, phosphatonins, mouse genetics, and CNS and bone *Examines essential updates on estrogen prevention and treatment and the recent results from the WHI *Discusses the controversial topics of screening and clinical trial design for drug registration *Includes essential updates on therapeutic uses of calcium, vitamin D, SERMS, bisphosphonates, and parathyroid hormone * Offers critical reviews of reproductive and hormonal risk factors, ethnicity, nutrition, therapeutics, management, and economics comprising a tremendous wealth of knowledge in a single source not found elsewhere
Diagnosis and Management of Osteoporosis by Kenneth G. Saag,Sarah L. Morgan,Gregory A. Clines Pdf
Diagnosis and Management of Osteoporosis by Ken Saag, MD. PhD, Sarah Morgan, MD, MS, RD and Gregory A. Clines, M.D., Ph.D. provides practitioners with practical and authoritative guidance on state of the art management of this condition. The pathophysiology of osteoporosis is reviewed. The diagnosis and screening for osteoporosis is discussed at length, including the proper use of bone densitometry and qualitative bone ultrasound, as well as risk assessment tools. Proper clinical evaluation is delineated and nondrug therapy is reviewed. Pharmacologic treatment options with antiresorptive agents and bone formation stimulants are discussed in detail including results of key clinical trials. A separate chapter review evolving pathways and therapeutic targets
Medifocus Guidebook On: Osteoporosis by Medifocus.com, Inc. Staff Pdf
The MediFocus Guidebook on Osteoporosis is the most comprehensive, up-to-date source of information available. You will get answers to your questions, including risk factors of Osteoporosis, standard and alternative treatment options, leading doctors, hospitals and medical centers that specialize in Osteoporosis, results of the latest clinical trials, support groups and additional resources, and promising new treatments on the horizon. This one of a kind Guidebook offers answers to your critical health questions including the latest treatments, clinical trials, and expert research; high quality, professional level information you can trust and understand culled from the latest peer-reviewed journals; and a unique resource to find leading experts, institutions, and support organizations including contact information and hyperlinks. This Guidebook was updated on January 24, 2012.
Anabolic Treatments for Osteoporosis by James F. Whitfield,Paul Morley Pdf
Osteoporosis, a growing epidemic among women in North America, Europe, and Japan, is a painful, costly disease that has presented a treatment challenge to healthcare professionals. Until recently, therapies have focused on agents that slow bone resorption, and have had only limited success at increasing bone mass. However, exciting new developments are on the verge of changing the treatment of this debilitating disorder. Two anabolic agents, the parathyroid hormone (PTH) and the fluoride ion, show tremendous promise as tools for building and retaining bone - with no adverse side effects. Anabolic Treatments for Osteoporosis is a comprehensive account of the latest studies that have been carried out on these two agents, and a thorough assessment of their prospects as osteoporosis therapeutics. This unique book combines basic science and up-to-date clinical data to present a complete picture of this breakthrough in the treatment of a globally significant health issue.
Current Topics In Osteoporosis by Hong-wen Deng,Yao-zhong Liu,Chun-yuan Guo,Di Chen Pdf
This book reviews important topics in osteoporosis, with the emphasis on both clinical management and basic research of the disease. From the clinical perspective, topics covering pathogenesis, diagnosis, and treatment of osteoporosis are extensively elaborated. Several more chapters complement clinical overview of osteoporosis, that discuss the effects of nutrition and exercise to bone health, the application of biochemical markers in osteoporosis diagnosis, novel potential drug targets for osteoporosis treatment, and osteoporosis in males and in children. As the prevalence of osteoporosis now reaches epidemiological levels, epidemiology and social impacts of osteoporosis is also reviewed in the book. Basic research on osteoporosis is also highlighted in the book, with a number of chapters dedicated to the review of genetics of osteoporosis, animal models for osteoporosis, and statistical methods in osteoporosis study.
Osteoporosis in Clinical Practice by Piet Geusens Pdf
A concise review of the current knowledge of osteoporosis, aimed at the busy pratitioner who is increasingly involved in the management of osteoporosis and who wants accurate and practical answers to questions that arise in daily clinical practice. All the major aspects are covered including diagnosis, fractures, prevention and treatment. Each chapter has been written by a recognised expert in the field to provide readers with the most up-to-date and authoritative knowledge on each of the topics discussed, making this an invaluable source of reference.