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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.

Designed to be a practical handbook on clinical trial management in these key therapeutic areas,'Clinical Trials in Rheumatoid Arthritis and Osteoarthritis'is aimed at principal investigators pharmaceutical physicians and other pharmaceutical staff involved in the design, conduct and monitoring of these increasingly complex diseases. In the last several years a new classes of biologic agents have emerged and changed the treatment paradigm for patients, not only with classically defined rheumatoid arthritis, but also with other related diseases such as ankylosing spondylitis and psoriatic arthritis. Furthermore, osteoarthritis is a major disease state that is often treated by the rheumatologist, but is one where patient management programs are currently limited with a need for new therapeutic approaches. In both inflammatory and non-inflammatory arthritic conditions, clinical trials have become both large and complex due to the nature of the diseases, with ever-challenging new surrogate end-points being employed. Topics covered in this title will therefore include study design, clinical endpoints, technical issues, data collection, use of centralized medical image reading facilities and biochemical marker laboratories, as well as data analysis and future therapies. This book takes the user through the process step-by-step from start to finish, also providing a background on the regulatory guidelines, ethical implications, endpoints, and current therapies.

COLING. MILLER ANDDEREKPEARSON 1. 1. Why a Book about Clinical Trials in Osteoporosis? There have been many books published about the design, conduct, and analysis of clinicaltrials. Whyareosteoporosistrialsaspecialcasethatdeserveabookoftheir own? There are three main reasons. First, most diseases have a well-understood definitionandaetiology. Osteoporosisisadiseasethatisunderstoodbythosewo- ing within the subspecialty, but currently there is no definition that is agreeable to both medical and scientific communities and its aetiology is poorly understood. It is within this framework that the pharmaceutical industry is trying to develop new treatmentsfortheso-called“silentepidemic”. In layman's terms, the disease of osteoporosis is defined as “brittle bones occurring in the elderly that could lead to fractures. ”The classical definition was “a bony fracture caused by minimal trauma owing to a loss in bone mineral. ” A published consensus definition states that osteoporosis is “a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to 1 fractures. ” The National Institutes of Health (NIH) Consensus Conference Statement on Osteoporosis Prevention, Diagnosis, and Therapy states that “osteoporosis is a skeletal disorder characterized by compromised bone strength 2 predisposing to an increased risk of fracture. ” The World Health Organization (WHO) operationally defines osteoporosis as “bone density 2. 5 standard dev- tions (SDs) below the mean for young white adult women at lumbar spine, 3 femoralneck,orforearm”. Itisnowrecommendedthatthediagnosticuseofthis 4 definition is restricted to bone density of the femur.