Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis
Phase 3
18 Years
85 Years
18 Years
85 Years
Not Enrolling
Both
Osteoporosis
Both
Osteoporosis
Trial Information
Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis
Inclusion Criteria:
- Long duration treatment with corticosteroids (started or ongoing)
Exclusion Criteria:
- History of osteogenesis imperfecta, multiple myeloma or Paget's disease
- History of Hyperparathyroidism, hyperthyroidism
- History of Osteomalacia
Other protocol-defined inclusion/exclusion criteria may apply.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Percent change in lumbar spine Bone Mineral Density at Month 12 relative to baseline.
Authority:
United States: Food and Drug Administration
Study ID:
CZOL446O2306
NCT ID:
NCT00100620
Start Date:
June 2004
Completion Date:
April 2007
Related Keywords:
- Osteoporosis
- Corticosteroid induced osteoporosis
- prevention
- treatment
- zoledronic acid
- Osteoporosis
Name | Location |
|---|---|
| McGuire VA Medical Center | Richmond, Virginia 23249 |
| Center for Education and research on Therapeutics (CERTs) of Musculoskeletal Disorders | Birmingham, Alabama 35294-3708 |
| United Osteoporosis Centers | Gainesville, Georgia 30501 |
| Osteoporosis & Clinical Trials | Cumberland, Maryland 21502 |
| University of Ohio | Columbus, Ohio 43210 |
| Radiant Research | Wyomissing, Pennsylvania 19610 |
