Trial · NCT03064074
Safety of Fresolimumab in the Treatment of Osteogenesis Imperfecta
NCT03064074, Phase 1, Completed, Baylor College of Medicine; results first posted 2024-10-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety of Fresolimumab in the Treatment of Osteogenesis Imperfecta. Trials, record NCT03064074. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03064074
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety of Fresolimumab in the Treatment of Osteogenesis Imperfecta
- NCT number
- NCT03064074
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 11 participants, actual
- Lead sponsor
- Baylor College of Medicine
- Conditions
- Osteogenesis Imperfecta
- Interventions
- Fresolimumab
- First posted
- 2017-02-24
- Last updated
- 2024-12-04
- Results first posted
- 2024-10-08
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 6 months for single dose study and 12 months for repeat dose study | Safety of single and repeat doses of fresolimumab will be assessed in adult patients with moderate to severe osteogenesis imperfecta |
| Secondary | Percentage Change in Bone Turnover Markers or P1NP, Osteocalcin or Ocn, and C-terminal Telopeptide or CTX | 6 months in single dose study and 12 months in repeat dose study | Percentage change in bone turnover markers from baseline to Day 180 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 6 months for single dose study and 12 months for repeat dose study | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage Change in Bone Turnover Markers or P1NP, Osteocalcin or Ocn, and C-terminal Telopeptide or CTX | 6 months in single dose study and 12 months in repeat dose study | Percent change | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Stage 1 Low Dose | 2 | Participants | ||
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Stage 2 High Dose | 4 | Participants | ||
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Stage 2 Repeat Dose Every 6 Months | 2 | Participants | ||
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Stage 2 Repeat Doses Every 3 Months | 1 | Participants | ||
| Percentage Change in Bone Turnover Markers or P1NP, Osteocalcin or Ocn, and C-terminal Telopeptide or CTX | Stage 1 Low Dose | Percentage Change in P1NP | 28.31 | Standard Error 17.44 | Percent change |
| Percentage Change in Bone Turnover Markers or P1NP, Osteocalcin or Ocn, and C-terminal Telopeptide or CTX | Stage 2 High Dose | Percentage Change in P1NP | 24.95 | Standard Error 17.44 | Percent change |
| Percentage Change in Bone Turnover Markers or P1NP, Osteocalcin or Ocn, and C-terminal Telopeptide or CTX | Stage 2 Repeat Dose Every 6 Months | Percentage Change in P1NP | 118.63 | Standard Error 45.40 | Percent change |
| Percentage Change in Bone Turnover Markers or P1NP, Osteocalcin or Ocn, and C-terminal Telopeptide or CTX | Stage 2 Repeat Doses Every 3 Months | Percentage Change in P1NP | NA | Standard Error NA | Percent change |
| Percentage Change in Bone Turnover Markers or P1NP, Osteocalcin or Ocn, and C-terminal Telopeptide or CTX | Stage 1 Low Dose | Percentage Change in CTX | 49.89 | Standard Error 29.29 | Percent change |
| Percentage Change in Bone Turnover Markers or P1NP, Osteocalcin or Ocn, and C-terminal Telopeptide or CTX | Stage 2 High Dose | Percentage Change in CTX | -4.02 | Standard Error 33.82 | Percent change |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stage 1 Low Dose | 4 | |
| Overall Study | STARTED | Stage 2 High Dose | 4 | |
| Overall Study | STARTED | Stage 2 Repeat Dose Every 6 Months | 2 | |
| Overall Study | STARTED | Stage 2 Repeat Doses Every 3 Months | 1 | |
| Overall Study | COMPLETED | Stage 1 Low Dose | 4 | |
| Overall Study | COMPLETED | Stage 2 High Dose | 4 | |
| Overall Study | COMPLETED | Stage 2 Repeat Dose Every 6 Months | 2 | |
| Overall Study | COMPLETED | Stage 2 Repeat Doses Every 3 Months | 0 | |
| Overall Study | NOT COMPLETED | Stage 1 Low Dose | 0 | |
| Overall Study | NOT COMPLETED | Stage 2 High Dose | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | General Adverse events | Investigations | Stage 1 Low Dose | 4 | 4 | 38 |
| other | General Adverse events | Investigations | Stage 2 High Dose | 4 | 4 | 24 |
| other | General Adverse events | Investigations | Stage 2 Repeat Dose Every 6 Months | 2 | 2 | 13 |
| other | General Adverse events | Investigations | Stage 2 Repeat Doses Every 3 Months | 1 | 1 | 21 |
| serious | Fracture | Musculoskeletal and connective tissue disorders | Stage 1 Low Dose | 0 | 4 | 0 |
| serious | Fracture | Musculoskeletal and connective tissue disorders | Stage 2 High Dose | 0 | 4 | 0 |
| serious | Fracture | Musculoskeletal and connective tissue disorders | Stage 2 Repeat Dose Every 6 Months | 1 | 2 | 1 |
| serious | Fracture | Musculoskeletal and connective tissue disorders | Stage 2 Repeat Doses Every 3 Months | 1 | 1 | 2 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stage 1 Low Dose | 0 | 4 |
| Total, all-cause mortality | Stage 2 High Dose | 0 | 4 |
| Total, all-cause mortality | Stage 2 Repeat Dose Every 6 Months | 0 | 2 |
| Total, all-cause mortality | Stage 2 Repeat Doses Every 3 Months | 0 | 1 |
| Total, other adverse events | Stage 1 Low Dose | 4 | 4 |
| Total, other adverse events | Stage 2 High Dose | 4 | 4 |
| Total, other adverse events | Stage 2 Repeat Dose Every 6 Months | 2 | 2 |
| Total, other adverse events | Stage 2 Repeat Doses Every 3 Months | 1 | 1 |
| Total, serious adverse events | Stage 1 Low Dose | 0 | 4 |
| Total, serious adverse events | Stage 2 High Dose | 0 | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35113812 | DERIVED |
Source PubMed
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/NCT03064074
GET https://conductscience.org/api/trials/v1/NCT03064074/registered