Osteogenesis Imperfecta Clinical Trial
— MeteoroidOfficial title:
A Phase 2, Non-controlled, Open-Label, Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta
Verified date | June 2023 |
Source | Ultragenyx Pharmaceutical Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 1, 2018 |
Est. primary completion date | November 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mereo Investigator Site | Albuquerque | New Mexico |
United States | Mereo Investigator Site | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Ultragenyx Pharmaceutical Inc | Mereo BioPharma |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in radial Trabecular Volumetric Bone Mineral Density (mgHA/cm3) | High Resolution Peripheral Quantitative Computated Tomography | 12 months | |
Primary | Change in radial bone strength on Finite Element Analysis (N) | High Resolution Peripheral Quantitative Computated Tomography | 12 months | |
Secondary | Change in tibial Trabecular Volumetric Bone Mineral Density (mgHA/cm3) | High Resolution Peripheral Quantitative Computated Tomography | 12 months | |
Secondary | Change in tibial bone strength on Finite Element Analysis (N) | High Resolution Peripheral Quantitative Computated Tomography | 12 months |
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