"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.
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Foreword.- Introduction.-1. Study design and the pre-trial phase: Study design and endpoints. Ethical considerations. Standardisation and pre-trial quality control.-2. Performing the trial: Organisation of the clinical trial by the sponsor. Local organisation. Clinical trial quality assurance. Laboratory and instrument quality control.-3. Data analysis and presentation: Data analysis and presentation: writing a paper for publication.-4. Background: Current and future therapies for osteroporosis. The ideal drug for the treatment of osteoporosis. Instrument measurements in osteoporosis clinical trials: Evaluating the end points. Biochemical markers of bone turnover. Future therapies and clinical trials.-Appendix A: Glossary of terms.-Appendix B: Sample study data.-Index.
