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Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children

Osteogenesis Imperfecta Clinical Trial

Official title:
Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children

Clinical Trial Summary

Children with Osteogenesis Imperfecta (OI) have bone pain, low bone mass and fractures. There are no approved drugs for the treatment of OI in children, even though some intravenous (IV) bisphosphonates are used off-label in some countries. In a single dose, pharmacokinetic study, data showed that risedronate was well tolerated in 28 children with OI. This three year study will test the safety and efficacy of risedronate in the treatment of children with OI. For the first year, patients will be randomized to the risedronate and placebo groups in a 2:1 ratio. For the second and third years of the study, all patients will receive risedronate.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00106028
Study type Interventional
Source Warner Chilcott
Contact
Status Completed
Phase Phase 3
Start date November 2004
Completion date March 2010
View Details
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