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NCT04232657 · ClinicalTrials.gov registry record · Phase 2
Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI
A Phase 2 study of Spinal Cord Injury (=3 Years) and Sublesional Bone Loss Secondary to SCI, sponsored by VA Office of Research and Development.
- Active
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 2
- Study locations
NCT04232657: Active Phase 2 study of Spinal Cord Injury (=3 Years) and Sublesional Bone Loss Secondary to SCI, sponsored by VA Office of Research and Development.
NCT04232657 is a Phase 2 study of Spinal Cord Injury (=3 Years) and Sublesional Bone Loss Secondary to SCI that is active but no longer recruiting, run by VA Office of Research and Development. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04232657, a Phase 2 study of Spinal Cord Injury (=3 Years) and Sublesional Bone Loss Secondary to SCI, is active but no longer recruiting, sponsored by VA Office of Research and Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 2
- Study locations
Study Summary
Treatment for sublesional bone loss (osteoporosis) in persons with chronic, motor-complete spinal cord injury (SCI) has been limited and unsuccessful to date. Romosozumab, a sclerostin antagonist, has potential to increase bone formation (anabolic) and decrease bone resorption (anti-catabolic) in persons with chronic SCI. Conventional anti-resorptive therapy alone would not be anticipated to reverse sublesional bone loss in a timely manner because the skeleton below the level of lesion in chronic SCI is assumed to be in a low turnover state. However, because there is a high likelihood that the bone accrued while on romosozumab will be lost once discontinued, denosumab, an anti-resorptive agent, will be administered after treatment with romosozumab, to maintain or, possibly, to continue to increase, bone mineral density (BMD). The purpose of this study is to address the gap in the treatment of osteoporosis in individuals with chronic SCI by partially restoring BMD with romosozumab treatment for 12 months and then to maintain, or further increase, BMD with denosumab treatment for 12 months. A two group, randomized, double-blind, placebo-controlled clinical trial will be conducted in 39 participants who have chronic (\>3 years), motor-complete or incomplete SCI and areal BMD (aBMD) values at the distal femur of at the distal femur \<1.0 g/cm2 measured by dual photon X-ray absorptiometry (DXA). The intervention group will receive 12 months of romosozumab followed by 12 months of denosumab, and the control group will receive 12 months of placebo followed by 12 months denosumab.
Primary Outcome
Percent change of volumetric BMD (vBMD) (mg/cm\^3)at the distal femur, measured by peripheral quantitative computed tomography (pQCT) (slice thickness 2.4mm, default voxel size of 0.5mm), with 12 months of romosozumab therapy. vBMD measurements will be taken at baseline, month 6 and month 12.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Romosozumab
- DRUG Denosumab
Study Locations (2)
New Jersey
- Kessler Institute for Rehabilitation - West Orange
New York
- James J. Peters VA Medical Center, Bronx, NY - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2027-03-01 |
| Phase | Phase 2 |
What the registry record for NCT04232657 still lists
NCT04232657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 2 conditions, with Spinal Cord Injury (=3 Years) appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04232657 reports a single indexed study location in New Jersey, New York.
Frequently Asked Questions
What is clinical trial NCT04232657 about?
NCT04232657 is a clinical study titled "Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI". Treatment for sublesional bone loss (osteoporosis) in persons with chronic, motor-complete spinal cord injury (SCI) has been limited and unsuccessful to date. Romosozumab, a sclerostin antagonist, has potential to increase bone formation (anabolic) and decrease bone resorption (anti-catabolic) in pe...
What is the current status of trial NCT04232657?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2021-03-01. Estimated completion is 2027-03-01.
What conditions does trial NCT04232657 study?
This clinical trial studies the following conditions: Spinal Cord Injury (=3 Years), Sublesional Bone Loss Secondary to SCI.
What interventions are being tested in trial NCT04232657?
The interventions under investigation include: Placebo (DRUG), Romosozumab (DRUG), Denosumab (DRUG).
Who is sponsoring clinical trial NCT04232657?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04232657 being conducted?
This trial has 2 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04232657's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 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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