At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of osteogenesis imperfecta
- ✓Increased risk of fracture: either history of at least 1 radiographically confirmed, non-traumatic or low impact fracture plus low bone mineral density (BMD), OR very low BMD with or without history of fractures
- ✕Any bisphosphonate use within one year prior to enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children
In Brief
A Phase 3 clinical trial evaluating risedronate sodium (Actonel) and Placebo for Osteogenesis Imperfecta. Completed, enrolled 143 participants across 20 sites in 13 countries.
Detailed 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.
Study Details
Timeline
Interventions
risedronate tablet once a day for one year followed by risedronate once a day for two years
placebo tablet once a day for one year followed by risedronate once a day for two years