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Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI

Study acronym: Chronic Romo
StatusCompleted
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Study completion date changed from estimate of Mar 1, 2027 to Aug 24, 2026 · Eligibility criteria expanded, about 38 words · Study description revised Show 3 more changesShow less
    • Study completion date changed from estimate of Mar 1, 2027 to Aug 24, 2026
    • Eligibility criteria expanded, about 38 words
    • Study description revised
  2. Primary completion date: Feb 5, 2026 to Aug 1, 2026v11
  3. 2 versions Re-verified since May 7, 2024, no change to tracked fieldsv9-v10
  4. Primary completion date: Feb 1, 2024 to Feb 5, 2026 Start date: Oct 28, 2020 to Mar 1, 2021 · Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 39 to confirmed 36 · 4 morev8 Show 7 more changesShow less
    • Start date: Oct 28, 2020 to Mar 1, 2021
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 39 to confirmed 36
    • Completion date: Aug 1, 2024 to Mar 1, 2027
    • Eligibility criteria shortened, about 23 words
    • Study description expanded, about 9 words
    • Site details revised at 2 of 2 sites

    See this version in full on ClinicalTrials.gov ↗

  5. Site contacts updated at 1 of 2 sites Eligibility criteria shortened, about 1 word · Study description shortened, about 1 wordv7 Show 2 more changesShow less
    • Eligibility criteria shortened, about 1 word
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

Show 5 earlier versionsHide 5 earlier versions
  1. Site details revised at 1 of 2 sitesv6
  2. Site contacts updated at 1 of 2 sitesv5
  3. Re-verified, no change to tracked fieldsv4
  4. Trial status: Not Yet Recruiting to Recruiting Site details revised at 2 of 2 sitesv3 Show 1 more changeShow less
    • Site details revised at 2 of 2 sites
  5. Start date: Feb 1, 2020 to Oct 28, 2020v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04232657
Lead Sponsor VA Office of Research and Development
Collaborators: Kessler Institute for Rehabilitation
Conditions Spinal Cord Injury (=3 Years), Sublesional Bone Loss Secondary to SCI
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov