Trial · NCT05312697
Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis Imperfecta
NCT05312697, Phase 2, Terminated, Ultragenyx Pharmaceutical Inc; results first posted 2025-07-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis Imperfecta. Trials, record NCT05312697. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05312697
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis Imperfecta
- NCT number
- NCT05312697
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- Ultragenyx Pharmaceutical Inc
- Conditions
- Osteogenesis Imperfecta
- Interventions
- Setrusumab
- First posted
- 2022-04-05
- Last updated
- 2025-07-23
- Results first posted
- 2025-07-23
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change From Retreatment Baseline in Lumbar Spine Bone Mineral Density (BMD) Measured by Dual-Energy X-Ray Absorptiometry (DXA) After 12 Months of Setrusumab | Retreatment Baseline, Month 12 | |
| Secondary | Percentage Change From Retreatment Baseline in Total Hip BMD Measured by DXA at Month 12 of the Retreatment Period | Retreatment Baseline, Month 12 | |
| Secondary | Annualized New Fracture Rate as Confirmed by Radiograph During the Retreatment Period | Up to Month 12 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Change From Retreatment Baseline in Lumbar Spine Bone Mineral Density (BMD) Measured by Dual-Energy X-Ray Absorptiometry (DXA) After 12 Months of Setrusumab | Retreatment Baseline, Month 12 | No statistical analyses were performed. No primary analysis occurred, as it was planned to occur at the end of the Retreatment Period, reflecting 12 months of retreatment with setrusumab. | ||
| SECONDARY | Percentage Change From Retreatment Baseline in Total Hip BMD Measured by DXA at Month 12 of the Retreatment Period | Retreatment Baseline, Month 12 | No statistical analyses were performed. No primary analysis occurred, as it was planned to occur at the end of the Retreatment Period, reflecting 12 months of retreatment with setrusumab. | ||
| SECONDARY | Annualized New Fracture Rate as Confirmed by Radiograph During the Retreatment Period | Up to Month 12 | No statistical analyses were performed. No primary analysis occurred, as it was planned to occur at the end of the Retreatment Period, reflecting 12 months of retreatment with setrusumab. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Observation Period --> Setrusumab QM --> Setrusumab Q2M/Setrusumab Q2M | 2 | |
| Overall Study | COMPLETED | Observation Period --> Setrusumab QM --> Setrusumab Q2M/Setrusumab Q2M | 0 | |
| Overall Study | NOT COMPLETED | Observation Period --> Setrusumab QM --> Setrusumab Q2M/Setrusumab Q2M | 2 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Observation Period --> Setrusumab QM --> Setrusumab Q2M/Setrusumab Q2M | 0 | 2 |
| Total, other adverse events | Observation Period --> Setrusumab QM --> Setrusumab Q2M/Setrusumab Q2M | 0 | 2 |
| Total, serious adverse events | Observation Period --> Setrusumab QM --> Setrusumab Q2M/Setrusumab Q2M | 0 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05312697
GET https://conductscience.org/api/trials/v1/NCT05312697/registered