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.

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-calledsilentepidemic. 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.

A practical manual for clinicians/scientists coming to the subject new - provides a standard for existing centers to measure themselves against Specifically addresses clinical trials in osteoporosis (no such other book is in the Library of Congress Catalog) Combines a number of issues brought together for the first time Uniquely written both from the viewpoint of the technologist and the MD investigator as well as the pharmaceutical personnel In-depth coverage of Good Clinical Practice (GCP)

Klappentext

The second revised and updated edition of 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 takes 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.

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.

Zusammenfassung
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.

Inhalt
Study Design and the Pretrial Phase.- Study Design and Endpoints.- Ethical Considerations.- Standardization and Pretrial Quality Control.- Performing the Trial.- Organization of the Clinical Trial by the Sponsor.- Local Site Organization.- Clinical Trial Quality Assurance.- Laboratory and Instrument Quality Control.- Data Analysis and Presentation.- Data Analysis and Presentation: Writing a Paper for Publication.- Background.- Current Therapies for Osteoporosis.- The Ideal Drug for Treatment of Osteoporosis.- Instrument Measurements in Osteoporosis Clinical Trials: Evaluating the Endpoints.- Biochemical Markers of Bone Turnover.- Future Therapies and Clinical Trials.