Clinical Trials in OsteoporosisClinical Trials in Osteoporosisis 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 Osteoporosisis 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. |
Contents
Introduction | 1 |
Study Design and Endpoints | 7 |
Ethical Considerations | 25 |
Standardization and Pretrial Quality Control | 43 |
Organization of the Clinical Trial by the Sponsor | 69 |
Local Site Organization | 83 |
Clinical Trial Quality Assurance | 95 |
Laboratory and Instrument Quality Control | 123 |
Current and Future Therapies for Osteoporosis | 167 |
The Ideal Drug for the Treatment of Osteoporosis | 179 |
Instrument Measurements in Osteoporosis Clinical Trials Evaluating the Endpoints | 197 |
Biochemical Markers of Bone Turnover | 207 |
Future Therapies and Clinical Trials | 227 |
Glossary | 235 |
Sample Data from the Example Study Used in this Book | 239 |
Index | 242 |
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Common terms and phrases
adverse events alendronate alkaline phosphatase analysis assay assessment baseline biochemical markers bisphosphonates bone density bone formation bone loss bone mass Bone Miner Res bone mineral density bone resorption bone turnover calcium calibration change in BMD Clin Chem clinical trials collagen cross-calibration crosslinks densitometer disease dose DPyd drug endpoint ensure equipment estrogen etidronate evaluated femur Figure fracture risk g cm² hip fracture hormone instruments investigators IRB/IEC laboratory lumbar spine Lunar manufacturers markers of bone measurement method monitoring normal number of patients osteocalcin osteoclast Osteoporos Int parathyroid hormone placebo population positioning postmenopausal osteoporosis postmenopausal women precision prevention propeptide protocol quality control radiographs raloxifene randomized recruitment reduce risedronate sample serum significant spine phantom sponsor standard techniques technologist therapy treatment effect treatment of osteoporosis ultrasound vertebral vertebral fractures vitamin D X-ray absorptiometry