Guidelines For Preclinical Evaluation And Clinical Trials In Osteoporosis

Download Guidelines For Preclinical Evaluation And Clinical Trials In Osteoporosis full books in PDF, epub, and Kindle. Read online Guidelines For Preclinical Evaluation And Clinical Trials In Osteoporosis ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!

Guidelines for Preclinical Evaluation and Clinical Trials in Osteoporosis

Author : World Health Organization
Publisher :
ISBN 13 : 9789241545228
Total Pages : 68 pages
Book Rating : 4.5/5 (452 download)

DOWNLOAD NOW!

Book Synopsis Guidelines for Preclinical Evaluation and Clinical Trials in Osteoporosis by : World Health Organization

Download or read book Guidelines for Preclinical Evaluation and Clinical Trials in Osteoporosis written by World Health Organization and published by . This book was released on 1998-01-01 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Guidelines for the Clinical Evaluation of Drugs Used in the Treatment of Osteoporosis

Author : United States. Food and Drug Administration. Division of Metabolism and Endocrine Drug Products
Publisher :
ISBN 13 :
Total Pages : 16 pages
Book Rating : 4.:/5 (319 download)

DOWNLOAD NOW!

Book Synopsis 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

Download or read book Guidelines for the Clinical Evaluation of Drugs Used in the Treatment of Osteoporosis written by United States. Food and Drug Administration. Division of Metabolism and Endocrine Drug Products and published by . This book was released on 1979 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Guidelines for Preclinical and Clinical Evaluation of Agents Used in the Prevention Or Treatment of Postmenopausal Osteoporosis

Author : United States. Food and Drug Administration. Division of Metabolism and Endocrine Drug Products
Publisher :
ISBN 13 :
Total Pages : 20 pages
Book Rating : 4.:/5 (352 download)

DOWNLOAD NOW!

Book Synopsis Guidelines for Preclinical and Clinical Evaluation of Agents Used in the Prevention Or Treatment of Postmenopausal Osteoporosis by : United States. Food and Drug Administration. Division of Metabolism and Endocrine Drug Products

Download or read book Guidelines for Preclinical and Clinical Evaluation of Agents Used in the Prevention Or Treatment of Postmenopausal Osteoporosis written by United States. Food and Drug Administration. Division of Metabolism and Endocrine Drug Products and published by . This book was released on 1994 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Clinical Trials in Osteoporosis

Author : Derek Pearson
Publisher : Springer Science & Business Media
ISBN 13 : 1846285879
Total Pages : 294 pages
Book Rating : 4.8/5 (462 download)

DOWNLOAD NOW!

Book Synopsis Clinical Trials in Osteoporosis by : Derek Pearson

Download or read book Clinical Trials in Osteoporosis written by Derek Pearson and published by Springer Science & Business Media. This book was released on 2007-05-27 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Clinical Trials in Osteoporosis

Author : Derek Pearson
Publisher : Springer Science & Business Media
ISBN 13 : 1447137108
Total Pages : 280 pages
Book Rating : 4.4/5 (471 download)

DOWNLOAD NOW!

Book Synopsis Clinical Trials in Osteoporosis by : Derek Pearson

Download or read book Clinical Trials in Osteoporosis written by Derek Pearson and published by Springer Science & Business Media. This book was released on 2013-03-14 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Safe and Effective Medicines for Children

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309225493
Total Pages : 432 pages
Book Rating : 4.3/5 (92 download)

DOWNLOAD NOW!

Book Synopsis Safe and Effective Medicines for Children by : Institute of Medicine

Download or read book Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Glucocorticoid-induced Osteoporosis

Author : Andrea Giustina
Publisher : Karger Medical and Scientific Publishers
ISBN 13 : 3805572964
Total Pages : 213 pages
Book Rating : 4.8/5 (55 download)

DOWNLOAD NOW!

Book Synopsis Glucocorticoid-induced Osteoporosis by : Andrea Giustina

Download or read book Glucocorticoid-induced Osteoporosis written by Andrea Giustina and published by Karger Medical and Scientific Publishers. This book was released on 2002 with total page 213 pages. Available in PDF, EPUB and Kindle. Book excerpt: Osteoporosis is one of the most clinically relevant disabling chronic disease encountered in clinical practice. A common cause of osteoporosis is glucocorticoid excess, as glucocorticoids may increase bone resorption, inhibit bone formation, have indirect actions on bone by decreasing intestinal calcium absorption and induce hypercalciuria. This book presents a comprehensive overview of the effects of glucocorticoids on bone metabolism and structure and on the diagnosis and treatment of glucocorticoid-induced osteoporosis. It aims at providing updated information on the pathogenesis, diagnosis and treatment of this often dramatic complication of glucocorticoid excess. Being one of the few publications completely devoted to glucocorticoid-induced osteoporosis it will heighten the awareness of specialists who prescribe glucocorticoids of the clinical relevance of this treatment complication. 'Glucocorticoid-Induced Osteoporosis' is addressed to clinical experts as well as to general practitioners who will both benefit from the comprehensive and integrative view of the management of patients exposed to glucocorticoids.

Osteoporosis, Two-Volume Set

Author : Robert Marcus
Publisher : Academic Press
ISBN 13 : 0080538266
Total Pages : 1672 pages
Book Rating : 4.0/5 (85 download)

DOWNLOAD NOW!

Book Synopsis Osteoporosis, Two-Volume Set by : Robert Marcus

Download or read book Osteoporosis, Two-Volume Set written by Robert Marcus and published by Academic Press. This book was released on 2001-09-20 with total page 1672 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Current Topics In Osteoporosis

Author : Hong-wen Deng
Publisher : World Scientific
ISBN 13 : 9814480983
Total Pages : 562 pages
Book Rating : 4.8/5 (144 download)

DOWNLOAD NOW!

Book Synopsis Current Topics In Osteoporosis by : Hong-wen Deng

Download or read book Current Topics In Osteoporosis written by Hong-wen Deng and published by World Scientific. This book was released on 2005-05-09 with total page 562 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Prevention and Management of Osteoporosis

Author : WHO Scientific Group on Prevention and Management of Osteoporosis
Publisher : World Health Organization
ISBN 13 : 9241209216
Total Pages : 206 pages
Book Rating : 4.2/5 (412 download)

DOWNLOAD NOW!

Book Synopsis Prevention and Management of Osteoporosis by : WHO Scientific Group on Prevention and Management of Osteoporosis

Download or read book Prevention and Management of Osteoporosis written by WHO Scientific Group on Prevention and Management of Osteoporosis and published by World Health Organization. This book was released on 2003-12-31 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Rare Diseases and Orphan Products

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309158060
Total Pages : 442 pages
Book Rating : 4.3/5 (91 download)

DOWNLOAD NOW!

Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine

Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Aging Bones

Author : Gerald N. Grob
Publisher : JHU Press
ISBN 13 : 1421413191
Total Pages : 305 pages
Book Rating : 4.4/5 (214 download)

DOWNLOAD NOW!

Book Synopsis Aging Bones by : Gerald N. Grob

Download or read book Aging Bones written by Gerald N. Grob and published by JHU Press. This book was released on 2014-04-15 with total page 305 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Osteoporosis

Author : Royal College of Physicians of London
Publisher : Royal College of Physicians
ISBN 13 : 9781860160790
Total Pages : 126 pages
Book Rating : 4.1/5 (67 download)

DOWNLOAD NOW!

Book Synopsis Osteoporosis by : Royal College of Physicians of London

Download or read book Osteoporosis written by Royal College of Physicians of London and published by Royal College of Physicians. This book was released on 1999 with total page 126 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Pocket Reference to Osteoporosis

Author : Serge Livio Ferrari
Publisher : Springer
ISBN 13 : 3319267574
Total Pages : 98 pages
Book Rating : 4.3/5 (192 download)

DOWNLOAD NOW!

Book Synopsis Pocket Reference to Osteoporosis by : Serge Livio Ferrari

Download or read book Pocket Reference to Osteoporosis written by Serge Livio Ferrari and published by Springer. This book was released on 2018-12-28 with total page 98 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book responds to the daily needs of all clinicians treating patients with osteoporosis and provides a key reference guide for any challenges that arise in clinical practice. This book also covers the genetics of the disease, clinical presentation, diagnosis, and current and upcoming treatment recommendations in accordance with the latest international guidelines. Osteoporosis is a disease in which the density and quality of bone are greatly reduced, and as bones become more porous and fragile the risk of fracture increases greatly. It is one of the most common metabolic bone diseases globally with one in three women and one in five men at risk of an osteoporotic fracture, and can result in devastating physical, psychosocial, and economic consequences. However, in spite of this osteoporosis can often be overlooked and undertreated, thus there is a real need to raise awareness of this disease.

Prevention and Treatment of Osteoporosis in the High-Risk Patient

Author : Cyrus Cooper
Publisher : CRC Press
ISBN 13 : 0203010752
Total Pages : 127 pages
Book Rating : 4.2/5 (3 download)

DOWNLOAD NOW!

Book Synopsis Prevention and Treatment of Osteoporosis in the High-Risk Patient by : Cyrus Cooper

Download or read book Prevention and Treatment of Osteoporosis in the High-Risk Patient written by Cyrus Cooper and published by CRC Press. This book was released on 2005-01-25 with total page 127 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Biomaterials for Musculoskeletal Regeneration

Author : Bikramjit Basu
Publisher : Springer
ISBN 13 : 9811030596
Total Pages : 443 pages
Book Rating : 4.8/5 (11 download)

DOWNLOAD NOW!

Book Synopsis Biomaterials for Musculoskeletal Regeneration by : Bikramjit Basu

Download or read book Biomaterials for Musculoskeletal Regeneration written by Bikramjit Basu and published by Springer. This book was released on 2016-11-01 with total page 443 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers the basics of the biomaterials science its applications to bone tissue engineering. The introductory section describes the most necessary concepts and techniques related to the cell and molecular biology with a particular focus on evaluating the biocompatibility property. The layout of this book facilitates easier understanding of the area of bone tissue engineering. The book integrates the Materials Science and Biological Science. It covers processing and basic material properties of various biocompatible metals and ceramics-based materials, in vitro and in vivo biocompatibility and toxicity assessment in the context of bone tissue engineering, and processing and properties of metal-, ceramic- and polymer-based biocomposites, including the fabrication of porous scaffold materials. The book can be used as a textbook for senior undergraduate and graduate coursework. It will also be a useful reference for researchers and professionals working in the area.

Small Clinical Trials

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309171148
Total Pages : 221 pages
Book Rating : 4.3/5 (91 download)

DOWNLOAD NOW!

Book Synopsis Small Clinical Trials by : Institute of Medicine

Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.