At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, Incorporating an Open Label Substudy, in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With Setrusumab (BPS804)
In Brief
A Phase 2 clinical trial evaluating setrusumab, Calcium, and 2 other interventions for Osteogenesis Imperfecta, Type I and 2 related conditions. Completed, enrolled 112 participants across 25 sites in 5 countries.
Detailed Summary
The purpose of this study is to select a suitable dose of BPS804 by measuring the strength/quality of bone using a special type of CT scanner. Participants will be treated for 12 months and followed up for a further 12 months.
Study Details
Timeline
Interventions
Intravenous infusion
tablets
capsules
Following completion of the study treatment (Month 12) participants can receive an optional single dose of zoledronic acid. Participants can receive an optional further dose of zoledronic acid at Month 18 at the discretion of their treating physician.