Introduction.- I. Study Design and the Pre-trial Phase: Study Design and Endpoints.- Ethical Considerations.- Standardization and Pre-trial Quality Control.- II. Performing the Trial: Organization of the Clinical Trial by the Sponsor.- Local Site Organization.- Clinical Trial Quality Assurance.- Laboratory and Instrument Quality Control.- III. Data Analysis and Presentation: Data Analysis and Presentation: Writing a Paper for Publication.- IV. Background: Current Therapies for Osteoporosis.- The Ideal Drug for the Treatment of Osteoporosis.- Instrument Measurements in Osteoporosis Clinical Trials: Evaluating the Endpoints.- Biochemical Markers of Bone Turnover.- Future Therapies and Clinical Trials.- Appendix A: Glossary.- Appendix B: Sample Study Data.
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.
