Main description:

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. Clinical Trials in Osteoporosis takes the user through the process step-by-step from start to finish. It also provides a background on regulatory guidelines, ethical implications, endpoints, current therapies, and the ideal drug to use. It will serve as a practical manual for clinicians and scientists new to the subject and provide a standard for existing centers to measure themselves against.

Contents:

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.