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NCT03118570 · ClinicalTrials.gov registry record · Phase 2
A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804
A Phase 2 study, sponsored by Ultragenyx Pharmaceutical.
- Completed
- Registry status
- Phase 2
- Development phase
- 112
- Enrollment target
NCT03118570: Completed Phase 2 study, sponsored by Ultragenyx Pharmaceutical.
NCT03118570 is a Phase 2 study that has completed, run by Ultragenyx Pharmaceutical. The registered enrollment target is 112 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03118570, a Phase 2 study, has completed, sponsored by Ultragenyx Pharmaceutical.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 112 participants
- Enrollment target
Study Summary
The purpose of this study is to select a suitable dose of BPS804 by measuring the strength/quality of bone using a special type of CT scanner. Participants will be treated for 12 months and followed up for a further 12 months.
Primary Outcome
Assessed by high resolution peripheral quantitative computed tomography (HRpQCT). HRpQCT scans were performed on the participant's distal non-dominant arm. In cases of an arm that had been supported with rods or had significant deformity, the dominant limb was selected. Data presents the ratio of the means between the visit and Baseline from analysis of covariance (ANCOVA).
Interventions
- DIETARY_SUPPLEMENT Vitamin D
- DIETARY_SUPPLEMENT Calcium
- DRUG setrusumab
- DRUG zoledronic acid (optional)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2017-09-11 |
| Est. Completion | 2020-11-12 |
| Phase | Phase 2 |
What the finished NCT03118570 record still lists
NCT03118570 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower).
The record links to 0 conditions, and to 4 interventions - of which Vitamin D is the first listed.
NCT03118570 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03118570 about?
NCT03118570 is a clinical study titled "A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804". The purpose of this study is to select a suitable dose of BPS804 by measuring the strength/quality of bone using a special type of CT scanner. Participants will be treated for 12 months and followed up for a further 12 months.
What is the current status of trial NCT03118570?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 112 participants. The study started on 2017-09-11. Estimated completion is 2020-11-12.
What interventions are being tested in trial NCT03118570?
The interventions under investigation include: Vitamin D (DIETARY_SUPPLEMENT), Calcium (DIETARY_SUPPLEMENT), setrusumab (DRUG), zoledronic acid (optional) (DRUG).
Who is sponsoring clinical trial NCT03118570?
This trial is sponsored by Ultragenyx Pharmaceutical, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03118570's enrollment target sits among peer trials
112 631st of 2000 higher than 1,369 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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