Clinical Trials Logo
  1. Home
  2. Osteogenesis Imperfecta
  3. NCT05768854

Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta — Cosmic  

Osteogenesis Imperfecta Clinical Trial

Official title:
An Open-label, Randomized, Active-Controlled, Phase 3 Study of Setrusumab Compared With Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta Types I, III or IV

Clinical Trial Summary

The primary objective of the study is to evaluate the effect of setrusumab vs intravenous bisphosphonates (IV-BP) on reduction in fracture rate, including morphometric vertebral fractures in pediatric participants.

Clinical Trial Description

Participants will be randomized 1:1 to receive either setrusumab or IV-BP. Following randomization, participants will receive setrusumab or IV-BP for up to 24 months during the Active-controlled Period. At the end of the Active-controlled Period all participants will enter the Extension Period and participants assigned to IV-BP will transition to setrusumab. During the Extension Period, all participants will receive setrusumab for a minimum of 12 months or until setrusumab becomes commercially available in their respective country or the study is discontinued. The use of any bisphosphonate is prohibited throughout the Extension Period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05768854
Study type Interventional
Source Ultragenyx Pharmaceutical Inc
Contact
Status Active, not recruiting
Phase Phase 3
Start date June 14, 2023
Completion date June 2026
View Details
See also
  Status Clinical Trial Phase
Completed NCT03557567 - NGS Strategy Effectiveness in Molecular Diagnosis
Not yet recruiting NCT05559801 - Mesenchymal Cell Therapy in Osteogenesis Imperfecta (OI) Phase 1/Phase 2
Active, not recruiting NCT02531087 - Urinary Biomarkers of OI Pathobiology
Completed NCT01713231 - Effect of High-Dose Vitamin D on Bone Density in Osteogenesis Imperfecta Phase 4
Completed NCT00655681 - Prevention of Post Operative Bone Loss in Children N/A
Recruiting NCT06065111 - Study of Osteogenesis Imperfecta Tendon
Withdrawn NCT03216486 - An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Phase 2
Recruiting NCT06086613 - A First-in-Human Study Evaluating AGA2115 in Adult Healthy Volunteers Phase 1
Completed NCT04009733 - Epigenetic Regulation of Osteogenesis Imperfecta Severity : miROI Study N/A
Completed NCT04231916 - High Resolution Thermal Imaging to Identify Vertebral Fractures in Children and Young People With Osteogenesis Imperfecta N/A
Active, not recruiting NCT02814591 - Development of a Non-invasive Assessment of Human Bone Quality Using Spatially Offset Raman Spectroscopy
Completed NCT00982124 - An Efficacy and Safety Trial of Intravenous Zoledronic Acid in Infants Less Than One Year of Age, With Severe Osteogenesis Imperfecta Phase 3
Completed NCT00001305 - Growth Hormone Therapy in Osteogenesis Imperfecta Phase 3
Completed NCT04119388 - Evaluation of the Benefits of Adaptive Physical Activity in Children and Adolescents With Osteogenesis Imperfecta N/A
Terminated NCT01679080 - The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta Phase 2
Completed NCT00106028 - Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children Phase 3
Recruiting NCT04152551 - Effects of Bisphosphonates on OI-Related Hearing Loss Phase 4
Completed NCT00705120 - Treatment of Severe Osteogenesis Imperfecta by Allogeneic Bone Marrow Transplantation Phase 1
Recruiting NCT04169568 - Osteogenesis Imperfecta Blood Pressure Study
Completed NCT03064074 - Safety of Fresolimumab in the Treatment of Osteogenesis Imperfecta Phase 1