Clinical Trial: A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 2b Study, Multicentre, Multinational, Placebo-controlled, Double-blind, Dose-finding Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804
Brief Summary: The purpose of this study is to select a suitable dose of BPS804 by comparing it with a dummy treatment and measuring the strength/quality of bone using a special type of CT scanner. Participants will be treated for 1 year.
Detailed Summary:
Sponsor: Mereo BioPharma
Current Primary Outcome:
- Change in Trabecular Volumetric Bone Mineral Density (mgHA/cm3) [ Time Frame: 6 months ]High Resolution Peripheral Quantitative Computated Tomography
- Change in bone strength on Finite Element Analysis (N) [ Time Frame: 6 months ]High Resolution Peripheral Quantitative Computated Tomography
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in Trabecular Volumetric Bone Mineral Density (mgHA/cm3) [ Time Frame: 12 months ]High Resolution Peripheral Quantitative Computative Tomography
- Change in bone strength on Finite Element Analysis (N) [ Time Frame: 12 months ]High Resolution Peripheral Quantitative Computative Tomography
- Change in Quality of Life Patient Reported Outcome Scores (total & sub-domains) [ Time Frame: 6 and 12 months ]OI-QOL-A
- Change in Quality of Life Patient Reported Outcome Scores (total & sub-domains) [ Time Frame: 6 and 12 months ]SF-12
- Change in Quality of Life Patient Reported Outcome Scores (total & sub-domains) [ Time Frame: 6 and 12 months ]EQ5D
- Changes in lumbar bone mineral density (t-score) [ Time Frame: 6 and 12 months ]Dual-energy x-ray absorptiometry
- Changes in whole body bone mineral density (t-score) [ Time Frame: 6 and 12 months ]Dual-energy x-ray absorptiometry
- Changes in proximal femur bone mineral density (t-score) [ Time Frame: 6 and 12 months ]Dual-energy x-ray absorptiometry
Original Secondary Outcome: Same as current
Information By: Mereo BioPharma
Dates:
Date Received: April 3, 2017
Date Started: May 3, 2017
Date Completion: May 31, 2019
Last Updated: May 3, 2017
Last Verified: May 2017