Trial · NCT04708886
Romosozumab in Women With Chronic SCI
NCT04708886, Phase 2, Completed, Northwestern University; results first posted 2025-09-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Romosozumab in Women With Chronic SCI. Trials, record NCT04708886. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04708886
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Romosozumab in Women With Chronic SCI
- NCT number
- NCT04708886
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Osteoporosis, Bone Loss, Osteopenia, Osteoporosis, Spinal Cord Injuries, Chronic Spinal Paralysis
- Interventions
- Romosozumab, Alendronate
- First posted
- 2021-01-14
- Last updated
- 2025-09-24
- Results first posted
- 2025-09-24
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Integral vBMC at the Knee (Distal Femur) | Baseline - 12 months | Change from baseline to the Month 12 visit in volumetric bone mineral content (vBMC) obtained via CT (three-dimensional) imaging of the knee. |
| Secondary | Change in BMD at the Total Hip and Femoral Neck | Baseline - 12 months | Change from baseline to the Month 12 visit in bone mineral density (BMD) obtained via DXA (two-dimensional) imaging of the total hip. |
| Secondary | Change in vBMC at the Hip | Baseline - 12 months | Change from baseline to the Month 12 visit in volumetric bone mineral content (vBMC) obtained via CT imaging of the hip. |
| Secondary | Change in Serum Bone Biomarkers (CTX and P1NP) | Baseline - 12 months | Change from baseline to the Month 12 visit in serum levels of CTX and P1NP. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Integral vBMC at the Knee (Distal Femur) | Baseline - 12 months | Females with Chronic SCI | g | MEDIAN |
| SECONDARY | Change in BMD at the Total Hip and Femoral Neck | Baseline - 12 months | Females with Chronic SCI | g/cm^2 | MEDIAN |
| SECONDARY | Change in vBMC at the Hip | Baseline - 12 months | Females with Chronic SCI | g | MEDIAN |
| SECONDARY | Change in Serum Bone Biomarkers (CTX and P1NP) | Baseline - 12 months | Females with chronic SCI | ng/mL | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Integral vBMC at the Knee (Distal Femur) | Females With Chronic SCI | -0.78 | Inter-Quartile Range -1.93 to -0.60 | g | |
| Change in BMD at the Total Hip and Femoral Neck | Females With Chronic SCI | Total Hip | 0.023 | Inter-Quartile Range 0.016 to 0.033 | g/cm^2 |
| Change in BMD at the Total Hip and Femoral Neck | Females With Chronic SCI | Femoral Neck | 0.033 | Inter-Quartile Range 0.008 to 0.049 | g/cm^2 |
| Change in vBMC at the Hip | Females With Chronic SCI | 0.063 | Inter-Quartile Range -0.071 to 0.706 | g | |
| Change in Serum Bone Biomarkers (CTX and P1NP) | Females With Chronic SCI | CTX | -0.0093 | Inter-Quartile Range -0.048 to 0.025 | ng/mL |
| Change in Serum Bone Biomarkers (CTX and P1NP) | Females With Chronic SCI | P1NP | -18.25 | Inter-Quartile Range -23.56 to -4.27 | ng/mL |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Year 1: Romosozumab | STARTED | Females With Chronic SCI | 12 | |
| Year 1: Romosozumab | COMPLETED | Females With Chronic SCI | 12 | |
| Year 1: Romosozumab | NOT COMPLETED | Females With Chronic SCI | 0 | |
| Year 2: Alendronate | STARTED | Females With Chronic SCI | 12 | |
| Year 2: Alendronate | COMPLETED | Females With Chronic SCI | 10 | |
| Year 2: Alendronate | NOT COMPLETED | Females With Chronic SCI | 2 |
Source ClinicalTrials.gov
Adverse events112
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 | Injection site reaction | General disorders | Year 1: Romosozumab | 8 | 12 | 14 |
| other | Injection site reaction | General disorders | Year 2: Alendronate | 0 | 12 | 0 |
| other | Bone Pain | Musculoskeletal and connective tissue disorders | Year 1: Romosozumab | 3 | 12 | 3 |
| other | Bone Pain | Musculoskeletal and connective tissue disorders | Year 2: Alendronate | 0 | 12 | 0 |
| other | Urinary tract infection (UTI) | Renal and urinary disorders | Year 1: Romosozumab | 4 | 12 | 5 |
| other | Urinary tract infection (UTI) | Renal and urinary disorders | Year 2: Alendronate | 2 | 12 | 3 |
| other | Burn | Injury, poisoning and procedural complications | Year 1: Romosozumab | 2 | 12 | 2 |
| other | Burn | Injury, poisoning and procedural complications | Year 2: Alendronate | 0 | 12 | 0 |
| other | Wound infection | Skin and subcutaneous tissue disorders | Year 1: Romosozumab | 1 | 12 | 1 |
| other | Wound infection | Skin and subcutaneous tissue disorders | Year 2: Alendronate | 0 | 12 | 0 |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Year 1: Romosozumab | 0 | 12 |
| Total, all-cause mortality | Year 2: Alendronate | 0 | 12 |
| Total, other adverse events | Year 1: Romosozumab | 12 | 12 |
| Total, other adverse events | Year 2: Alendronate | 9 | 12 |
| Total, serious adverse events | Year 1: Romosozumab | 0 | 12 |
| Total, serious adverse events | Year 2: Alendronate | 2 | 12 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Year 1: Romosozumab vs Year 2: Alendronate: deaths from any cause | Trial comparisons |
| Year 1: Romosozumab vs Year 2: Alendronate: serious adverse events | Trial comparisons |
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/NCT04708886
GET https://conductscience.org/api/trials/v1/NCT04708886/events?page=2