A Phase 2 interventional study of Zoledronic Acid in Osteogenesis Imperfecta, sponsored by Novartis Pharmaceuticals. Completed at 10 sites in United States. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2017-06-01.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
This is an extension study to examine the long-term safety and efficacy of zoledronic acid in patients who have completed the core CZOL446H2202 study.
85 studies on the registry are indexed under Osteogenesis Imperfecta; 20 are open to participants now.
This study's enrollment of 127 is above the median of 26 across 59 interventional studies indexed under Osteogenesis Imperfecta.
Browse Osteogenesis Imperfecta 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.
Long-term safety of two different zoledronic acid doses over an additional 12 months in patients who have completed one year treatment in CZOL446H2202
Measure percentage change of lumbar spine bone mineral density at month 18 and 24 compared to baseline in the core study.
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals