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Author : United States. Food and Drug Administration. Division of Metabolism and Endocrine Drug Products
Publisher : Unknown
Page : 16 pages
File Size : 44,9 Mb
Release : 1979
Category : Drugs
ISBN : MINN:31951003056736G
Author : World Health Organization
Publisher : Unknown
Page : 68 pages
File Size : 49,5 Mb
Release : 1998-01-01
Category : Medical
ISBN : 9241545224
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 : Eric S. Orwoll,John P. Bilezikian,Dirk Vanderschueren
Publisher : Academic Press
Page : 764 pages
File Size : 41,6 Mb
Release : 2009-11-30
Category : Medical
ISBN : 9780080923468
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
Author : Anonim
Publisher : Unknown
Page : 20 pages
File Size : 47,9 Mb
Release : 1981
Category : Antineoplastic agents
ISBN : MINN:31951003059596R
Author : United States. Food and Drug Administration. Division of Oncology and Radiopharmaceutical Drug Products
Publisher : Unknown
Page : 24 pages
File Size : 53,9 Mb
Release : 1981
Category : Radioisotopes
ISBN : UCSD:31822024356768
Author : United States. Food and Drug Administration. Bureau of Drugs
Publisher : Unknown
Page : 24 pages
File Size : 45,9 Mb
Release : 1981
Category : Drugs
ISBN : UOM:39015007142584
Author : Kenneth G. Saag,Sarah L. Morgan,Gregory A. Clines
Publisher : Unknown
Page : 298 pages
File Size : 55,5 Mb
Release : 2017-08-14
Category : Bones
ISBN : 1943236135
Diagnosis and Management of Osteoporosis, 2nd edition 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 reviews evolving pathways and therapeutic targets.
Author : United States. Food and Drug Administration. Division of Neuropharmacological Drug Products
Publisher : Unknown
Page : 20 pages
File Size : 41,5 Mb
Release : 1981
Category : Anticonvulsants
ISBN : UCSD:31822024356594
Author : United States. Food and Drug Administration. Division of Metabolism and Endocrine Drug Products
Publisher : Unknown
Page : 20 pages
File Size : 45,5 Mb
Release : 1980
Category : Antilipemic agents
ISBN : MINN:31951003059551D
Author : Gary M. Matoren
Publisher : CRC Press
Page : 584 pages
File Size : 50,7 Mb
Release : 2020-08-18
Category : Business & Economics
ISBN : 9781000148718
This book examines the sequence of events and methodology in the industrial clinical research process; a reference for multidisciplinary personnel. It is the conceptual framework involving the philosophical, economic, political, historical, regulatory, planning, and marketing aspects of the process.
Author : Karen Hertz,Julie Santy-Tomlinson
Publisher : Springer
Page : 169 pages
File Size : 54,8 Mb
Release : 2018-06-15
Category : Medical
ISBN : 9783319766812
This open access book aims to provide a comprehensive but practical overview of the knowledge required for the assessment and management of the older adult with or at risk of fragility fracture. It considers this from the perspectives of all of the settings in which this group of patients receive nursing care. Globally, a fragility fracture is estimated to occur every 3 seconds. This amounts to 25 000 fractures per day or 9 million per year. The financial costs are reported to be: 32 billion EUR per year in Europe and 20 billon USD in the United States. As the population of China ages, the cost of hip fracture care there is likely to reach 1.25 billion USD by 2020 and 265 billion by 2050 (International Osteoporosis Foundation 2016). Consequently, the need for nursing for patients with fragility fracture across the world is immense. Fragility fracture is one of the foremost challenges for health care providers, and the impact of each one of those expected 9 million hip fractures is significant pain, disability, reduced quality of life, loss of independence and decreased life expectancy. There is a need for coordinated, multi-disciplinary models of care for secondary fracture prevention based on the increasing evidence that such models make a difference. There is also a need to promote and facilitate high quality, evidence-based effective care to those who suffer a fragility fracture with a focus on the best outcomes for recovery, rehabilitation and secondary prevention of further fracture. The care community has to understand better the experience of fragility fracture from the perspective of the patient so that direct improvements in care can be based on the perspectives of the users. This book supports these needs by providing a comprehensive approach to nursing practice in fragility fracture care.
Author : Anonim
Publisher : Unknown
Page : 97 pages
File Size : 46,9 Mb
Release : 2012
Category : Electronic
ISBN : OCLC:833312511
There are a number of therapies and treatments available for the prevention of fragility fractures in people thought to be at risk, or to prevent further fractures in those who have already had one or more fragility fractures. However, identifying who will benefit from preventative treatment is imprecise. A number of risk assessment tools are available to predict fracture incidence over a period of time, and these may be used to aid decision making. These tools are limited in that they may not include all risk factors, or may lack details of some risk factors. Tools are dependent on the accuracy of the epidemiological data used to derive them and tools validated in other populations may not apply to the UK. Two tools, FRAX and QFracture, are available for use in the UK. It is not clear whether these tools are equally accurate and whether choice of tool should depend on circumstances. This short clinical guideline aims to provide guidance on the selection and use of risk assessment tools in the care of people who may be at risk of fragility fractures in all settings in which NHS care is received.
Author : Karl E. Peace
Publisher : CRC Press
Page : 387 pages
File Size : 51,5 Mb
Release : 2017-09-19
Category : Mathematics
ISBN : 9781351414449
This book is a compilation of topics addressed by the ASA Biopharmaceutical Section work groups, including the etiology and evolution of the work groups, the work group guidelines and structure, and the statistical issues associated with clinical trials in clinical drug development programs.
Author : United States. Food and Drug Administration. Bureau of Drugs
Publisher : Unknown
Page : 20 pages
File Size : 41,9 Mb
Release : 1977
Category : Chemotherapy
ISBN : MINN:319510000958668
Author : Andrea Giustina,Alberto Angeli,Ernesto Canalis
Publisher : Karger Medical and Scientific Publishers
Page : 213 pages
File Size : 48,6 Mb
Release : 2002
Category : Medical
ISBN : 9783805572965
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.