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