A Phase 3 interventional study of Zoledronic Acid in Osteoporosis, sponsored by Novartis Pharmaceuticals. Completed at 6 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-05-17.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
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.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 802 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Percent change in lumbar spine Bone Mineral Density at Month 12 relative to baseline.
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
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals