Osteoporosis
Conditions
Keywords
Corticosteroid induced osteoporosis, prevention, treatment, zoledronic acid
Brief summary
The intake of high doses of corticosteroids is known to play an important role in the weakening of the bones and is thus an increasing fracture risk. Zoledronic acid (Aclasta) is a drug known for its protective effect in some bone diseases (tumors, paget). This study will test the safety and efficacy of zoledronic acid in the prevention and treatment of corticosteroid induced osteoporosis in male and female patients.
Interventions
DRUGZoledronic Acid
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in lumbar spine Bone Mineral Density at Month 12 relative to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent change in lumbar spine Bone Mineral Density at Month 6 relative to baseline | — |
| Percent change in total hip, femoral neck, trochanter and distal radius Bone Mineral Density at Months 6 and 12 relative to baseline | — |
| Biochemical markers of bone turnover at Baseline, Day 10, Month 3, Month 6, Month 12 | — |
| Overal safety of zoledronic acid compared to risedronate in patients receiving corticosteroid therapy | — |
Countries
United States
Outcome results
None listed