Clinical Trials in Osteoporosis

About this book

A practical manual for clinicians/scientists new to the subject
Provides a standard for existing centers to measure themselves against
Specifically addresses clinical trials in osteoporosis
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
Features in-depth coverage of Good Clinical Practice (GCP)

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.

Written for:

Rheumatologists, endocrinologists, obstetrics and gynecology specialists

Keywords:

• Clinical Trials
• Methodology
• Osteoporosis
• Study

Table of contents

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.