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Administrative Reason
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| Name | Class |
|---|---|
| Mereo BioPharma | INDUSTRY |
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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.
This study was previously posted by Mereo Biopharma and was transferred to Ultragenyx in February 2021.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BPS804 Dose 1 | Experimental | BPS804 IV Infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPS804 | Drug | IV administration of BPS804 in 5% Dextrose solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in radial Trabecular Volumetric Bone Mineral Density (mgHA/cm3) | High Resolution Peripheral Quantitative Computated Tomography | 12 months |
| Change in radial bone strength on Finite Element Analysis (N) | High Resolution Peripheral Quantitative Computated Tomography | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in tibial Trabecular Volumetric Bone Mineral Density (mgHA/cm3) | High Resolution Peripheral Quantitative Computated Tomography | 12 months |
| Change in tibial bone strength on Finite Element Analysis (N) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Ultragenyx Pharmaceutical Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mereo Investigator Site | Albuquerque | New Mexico | 87106 | United States | ||
| Mereo Investigator Site |
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| ID | Term |
|---|---|
| D010013 | Osteogenesis Imperfecta |
| ID | Term |
|---|---|
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C000622723 | setrusumab |
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Single arm, open-label
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High Resolution Peripheral Quantitative Computated Tomography
| 12 months |
| Houston |
| Texas |
| 77030 |
| United States |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |