TrialSignal
Clinical trial intelligence report
Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jun 13, 2026
NCT ID
NCT00106028
Status
COMPLETED
Phase
PHASE3
Sponsor
Warner Chilcott
Executive brief
Investment-Ready Snapshot
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.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT00106028
Indication
Osteogenesis Imperfecta
Modality
small molecule
Target
risedronate sodium (Actonel), Placebo
Intervention
risedronate sodium (Actonel), Placebo
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.