Food and Drug Administration
Center for Drug Evaluation and Research
Endocrinologic and Metabolic Drugs Advisory Committee
The Hilton, 8727 Colesville Road, Silver Spring, MD
September 25, 2002
Clinical Trials for New Osteoporosis Treatments
In recent years, typical registration dossiers for new drugs for postmenopausal osteoporosis have included trials demonstrating:
2. For prevention, demonstration of a statistically significant increase in lumbar spine bone mineral density vs. placebo over 2 years, as well as demonstration of anti-fracture efficacy from a treatment trial.
Considering the following hypothetical osteoporosis drugs (or others) in development:
To what extent should we modify the standard(s) of clinical evidence required to approve a drug for the prevention and treatment of postmenopausal osteoporosis?
4. When is the use of a placebo or active control appropriate?