Clinical Trials Logo
  1. Home
  2. Osteogenesis Imperfecta
  3. NCT05972551

Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta

Osteogenesis Imperfecta Clinical Trial

Official title:
A Phase 3, Open-Label, Multicenter, Randomized Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta

Clinical Trial Summary

The primary objective of this study is to evaluate the effect of romosozumab treatment for 12-months compared with bisphosphonate(s) on the number of clinical fractures at 12-months; the number of any fractures at 12-months and change in lumbar spine bone mineral density (BMD) Z-score at 6-months.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05972551
Study type Interventional
Source Amgen
Contact Amgen Call Center
Phone 866-572-6436
Email medinfo@amgen.com
Status Recruiting
Phase Phase 3
Start date April 22, 2024
Completion date May 27, 2027
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Withdrawn NCT03216486 - An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Phase 2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