An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta
- Registration Number
- NCT03216486
- Lead Sponsor
- Ultragenyx Pharmaceutical Inc
- Brief Summary
The purpose of this study is to investigate the effect of BPS804 on strength/quality of bone in patients with Type I, III or IV Osteogenesis imperfecta using a special type of CT scanner. Participants will be treated for 1 year.
- Detailed Description
This study was previously posted by Mereo Biopharma and was transferred to Ultragenyx in February 2021.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Patients with a clinical diagnosis of OI Type I, III or IV
- Capable of giving signed consent
Exclusion Criteria
- History of skeletal malignancies or other bone diseases (other than OI)
- History of endocrine or thyroid/parathyroid conditions that could affect bone metabolism
- Treatment with bisphosphonates within 3 months of randomisation
- Treatment with teraparatide, denosomab or other anabolic/antiresorbative medications within 6 months of randomisation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BPS804 Dose 1 BPS804 BPS804 IV Infusion
- Primary Outcome Measures
Name Time Method Change in radial bone strength on Finite Element Analysis (N) 12 months High Resolution Peripheral Quantitative Computated Tomography
Change in radial Trabecular Volumetric Bone Mineral Density (mgHA/cm3) 12 months High Resolution Peripheral Quantitative Computated Tomography
- Secondary Outcome Measures
Name Time Method Change in tibial Trabecular Volumetric Bone Mineral Density (mgHA/cm3) 12 months High Resolution Peripheral Quantitative Computated Tomography
Change in tibial bone strength on Finite Element Analysis (N) 12 months High Resolution Peripheral Quantitative Computated Tomography
Trial Locations
- Locations (1)
Mereo Investigator Site
🇺🇸Houston, Texas, United States