Guidelines For Preclinical Evaluation And Clinical Trials In Osteoporosis

Author : World Health Organization
Publisher : Unknown
Page : 68 pages
File Size : 48,8 Mb
Release : 1998-01-01
Category : Medical
ISBN : 9241545224

Get Book

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.

Author : United States. Food and Drug Administration. Division of Metabolism and Endocrine Drug Products
Publisher : Unknown
Page : 16 pages
File Size : 50,5 Mb
Release : 1979
Category : Drugs
ISBN : MINN:31951003056736G

Get Book

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

Author : Derek Pearson,Colin G. Miller
Publisher : Springer Science & Business Media
Page : 294 pages
File Size : 51,6 Mb
Release : 2007-05-27
Category : Medical
ISBN : 9781846285875

Get Book

Clinical Trials in Osteoporosis by Derek Pearson,Colin G. Miller Pdf

This second revised and updated edition 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. Clinical Trials in Osteoporosis takes the user through the process step-by-step from start to finish. It also provides a background on regulatory guidelines, ethical implications, endpoints, current therapies, and the ideal drug to use. It will serve as a practical manual for clinicians and scientists new to the subject and provide a standard for existing centers to measure themselves against.

Author : Derek Pearson,Colin G. Miller
Publisher : Springer Science & Business Media
Page : 258 pages
File Size : 46,5 Mb
Release : 2013-03-14
Category : Medical
ISBN : 9781447137108

Get Book

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.

Author : WHO Scientific Group on Prevention and Management of Osteoporosis,World Health Organization
Publisher : World Health Organization
Page : 206 pages
File Size : 55,6 Mb
Release : 2003-12-31
Category : Medical
ISBN : 9789241209212

Get Book

Prevention and Management of Osteoporosis by WHO Scientific Group on Prevention and Management of Osteoporosis,World Health Organization Pdf

Bone is hard tissue that is in a constant state of flux being built up by bone-forming cells called osteoblasts while also being broken down or resorbed by cells known as osteoclasts. During childhood and adolescence bone formation is dominant; bone length and girth increase with age ending at early adulthood when peak bone mass is attained. Males generally exhibit a longer growth period resulting in bones of greater size and overall strength. In males after the age of 20 bone resorbtion becomes predominant and bone mineral content declines about 4% per decade. Females tend to maintain peak mineral content until menopause at which time it declines about 15% per decade. Osteoporosis is a disease characterized by low bone mass and structural deterioration of bone tissue leading to bone fragility and an increased susceptibility to fractures especially of the hip spine and wrist. Osteoporosis occurs primarily as a result of normal ageing but can arise as a result of impaired development of peak bone mass (e.g. due to delayed puberty or undernutrition) or excessive bone loss during adulthood (e.g. due to estrogen deficiency in women undernutrition or corticosteriod use). Osteoporosis-induced fractures cause a great burden to society. Hip fractures are the most serious as they nearly always result in hospitalization are fatal about 20% of the time and produce permanent disability about half the time. Fracture rates increase rapidly with age and the lifetime risk of fracture in 50 year-old women is about 40% similar to that for coronary heart disease. In 1990 there were 1.7 million hip fractures alone worldwide; with changes in population demographics this figure is expected to rise to 6 million by 2050. To help describe the nature and consequences of osteoporosis as well as strategies for its prevention and management a WHO Scientific Group meeting of international experts was held in Geneva which resulted in this technical report. This monograph describes in detail normal bone development and the causes and risk factors for developing osteoporosis. The burden of osteoporosis is characterized in terms of mortality morbidity and economic costs. Methods for its prevention and treatment are discussed in detail for both pharmacological and non-pharmacological approaches. For each approach the strength of the scientific evidence is listed. The report also provides cost-analysis information for potential interventions and discusses important aspects of developing national policies to deal with osteoporosis. Recommendations are made to the general population care providers health administrators and researchers. Lastly national organizations and support groups are listed by country.

Author : Robert Marcus,David Feldman,Jennifer Kelsey
Publisher : Academic Press
Page : 1672 pages
File Size : 50,7 Mb
Release : 2001-09-20
Category : Medical
ISBN : 9780080538266

Get Book

Osteoporosis, Two-Volume Set by Robert Marcus,David Feldman,Jennifer Kelsey Pdf

Osteoporosis is the most comprehensive, authoritative reference on this disease. Some of the topics covered include basic biology, anatomy, physiology, pathophysiology, preclinical issues, experimental medicine, management, and therapeutics. Written by renowned experts in this field, this book is a must-have for the researcher, the academic clinician, or anyone in the field of bone biology. Key Features * The source on osteoporosis * Written by expert investigators in their respective fields * Each chapter provides timely, comprehensive, and scholarly discussion * Fully illustrated in color and black & white * Covers everything from basic anatomy and physiology to diagnosis, management and treatment

Author : Hong-wen Deng,Yao-Zhong Liu
Publisher : World Scientific
Page : 562 pages
File Size : 54,7 Mb
Release : 2005
Category : Medical
ISBN : 9789812561534

Get Book

Current Topics in Osteoporosis by Hong-wen Deng,Yao-Zhong Liu 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.

Author : Cyrus Cooper,Stephen H. Gehlbach,Robert Lindsay
Publisher : CRC Press
Page : 127 pages
File Size : 40,7 Mb
Release : 2005-01-25
Category : Medical
ISBN : 9780203010754

Get 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

Author : Gerald N. Grob
Publisher : JHU Press
Page : 305 pages
File Size : 40,8 Mb
Release : 2014-04-15
Category : Medical
ISBN : 9781421413198

Get Book

Aging Bones by Gerald N. Grob Pdf

How osteoporosis went from a normal aging process to a disease. In the middle of the twentieth century, few physicians could have predicted that the modern diagnostic category of osteoporosis would emerge to include millions of Americans, predominantly older women. Before World War II, popular attitudes held that the declining physical and mental health of older persons was neither preventable nor reversible and that older people had little to contribute. Moreover, the physiological processes that influenced the health of bones remained mysterious. In Aging Bones, Gerald N. Grob makes a historical inquiry into how this one aspect of aging came to be considered a disease. During the 1950s and 1960s, as more and more people lived to the age of 65, older people emerged as a self-conscious group with distinct interests, and they rejected the pejorative concept of senescence. But they had pressing health needs, and preventing age-related decline became a focus for researchers and clinicians alike. In analyzing how the normal aging of bones was transformed into a medical diagnosis requiring treatment, historian of medicine Grob explores developments in medical science as well as the social, intellectual, economic, demographic, and political changes that transformed American society in the post–World War II decades. Though seemingly straightforward, osteoporosis and its treatment are shaped by illusions about the conquest of disease and aging. These illusions, in turn, are instrumental in shaping our health care system. While bone density tests and osteoporosis treatments are now routinely prescribed, aggressive pharmaceutical intervention has produced results that are inconclusive at best. The fascinating history in Aging Bones will appeal to students and scholars in the history of medicine, health policy, gerontology, endocrinology, and orthopedics, as well as anyone who has been diagnosed with osteoporosis.

Author : Royal College of Physicians of London
Publisher : Royal College of Physicians
Page : 126 pages
File Size : 54,6 Mb
Release : 1999
Category : Medical
ISBN : 1860160794

Get Book

Osteoporosis by Royal College of Physicians of London Pdf

Author : Klaus Olgaard,Isidro B. Salusky,Justin Silver
Publisher : OUP Oxford
Page : 616 pages
File Size : 51,5 Mb
Release : 2010-06-10
Category : Medical
ISBN : 9780191029325

Get Book

The Spectrum of Mineral and Bone Disorders in Chronic Kidney Disease by Klaus Olgaard,Isidro B. Salusky,Justin Silver Pdf

Despite significant improvement in the management of patients with chronic kidney disease, the morbidity and mortality remain high. However more is now understood about the hormonal influence on bone and vascular structures, and there have been major advances in the field of bone and mineral metabolism. This has lead to the development of new treatment strategies and agents. This new second edition reflects the most current thinking and understanding in this fascinating field, as presented by world basic and clinical experts.

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA)
Publisher : National Academies Press
Page : 432 pages
File Size : 41,9 Mb
Release : 2012-10-13
Category : Medical
ISBN : 9780309225496

Get Book

Safe and Effective Medicines for Children by Institute of Medicine,Board on Health Sciences Policy,Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) Pdf

The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

Author : James P. Waddell
Publisher : Elsevier Health Sciences
Page : 317 pages
File Size : 54,8 Mb
Release : 2010-09-24
Category : Medical
ISBN : 9781437736311

Get Book

Fractures of the Proximal Femur: Improving Outcomes E-Book by James P. Waddell Pdf

Fractures of the Proximal Femur: Improving Outcomes, by Dr. James P. Waddell, helps you maximize clinical outcomes when addressing the challenges, complications, and treatment of patients with hip fractures. Match pre-operative assessment, surgical techniques, post-operative management, and more to the specific lifestyle factors of each patient in order to achieve optimal results. Apply state-of-the-art techniques and protocols with the visual help of operative videos as well as more than 500 surgical line drawings and photographs in print and online at www.expertconsult.com. See how to perform each technique step by step with operative videos and online access at www.expertconsult.com. Review surgical techniques such as pinning, plating/intramedulary devices, and total hip replacement implants, and get a greater understanding of deep vein thrombosis and pulmonary embolism prevention. Brush up on related topics including epidemiology, osteoporosis, co-morbidities, evidence-based post-op, and rehabilitation protocols. Get the advice of expert contributors worldwide who detail best practices in prophylaxis, surgical technique, and rehabilitation.

Author : Robert S. Bar
Publisher : Springer Science & Business Media
Page : 452 pages
File Size : 50,9 Mb
Release : 2003-04-08
Category : Medical
ISBN : 9781592593781

Get Book

Early Diagnosis and Treatment of Endocrine Disorders by Robert S. Bar Pdf

Most endocrine diseases can be treated successfully, and the patient's state of well-being can usually be improved. Not surprisingly, the earlier the diagnosis is made the more positive the clinical response. Early Diagnosis and Treatment (~f Endocrine Disorders focuses on early signs and symptoms of endocrine disorders and surveys the appropriate tests to document the diseases as well as current recommendations for therapy. Each chapterreviews the pathophysiology of the endocrine disease-important for understanding each disorder as well as the rationale for early therapy-and the basis for the early recognition and treatment of each condition. Although the practicing endocrinologist is likely to be quite knowledgeable regarding many of these diseases, Early Diagnosis and Treatment of Endocrine Disorders includes treatment of those conditions only recently classified as endocrine disorders, such as polycystic ovarian syndrome, obesity, and hypogonadism. The book also provides new approaches that are urgently needed to slow the epidemic of type 2 diabetes, which should be an overriding concern for all clinicians. Until now, no other endocrinology text has focused primarily on the details of early recognition and therapy of endocrine disorders. The information in Early Diagnosis and Treatment of Endocrine Disorders is presented in an orderly and easy-to-follow manner, which should greatly facilitate the early recognition of endocrine diseases by medical students, house staff, primary care physicians, and endocrinologists, the four groups of clinical personnel to which this book is specificall y directed.

Author : Albert W. Taylor
Publisher : Human Kinetics
Page : 409 pages
File Size : 46,8 Mb
Release : 2021-11-15
Category : Aging
ISBN : 9781492597254

Get Book

Physiology of Exercise and Healthy Aging by Albert W. Taylor Pdf

"This text is written explicitly for readers with an interest in the aging process and the effects that exercise has on the quality of life and various diseases and maladies of the aging population. It is expected that the readers using this book as a course textbook or as auxiliary reading for a course, will have taken at least an introductory course in human physiology. The text refers throughout to the three groups in the aging and health spectrum, average aging individuals, the frail elderly and Masters Athletes"--