Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Spinal Cord Injury (=3 Years), Sublesional Bone Loss Secondary to SCI
In brief
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.
Key facts
- Study ID
- NCT04232657
- Run by
- VA Office of Research and Development
- People needed
- 36
- Starts
- 2021-03-01
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-04-20
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Motor-complete or incomplete SCI [all levels of lesion] classified using International Standards for Neurological Classification for Spinal Cord Injury (ISNCSCI) impairment scale] as ISNCSCI score A-C
- Duration of injury >3 years
- Males (18-65 years old) and females (premenopausal, between the ages of 18 and 55 years old).
- aBMD at the distal femur <1.0 g/cm2 (determined at screening)
You may not qualify if…
- Long-bone fracture of the leg within the past year
- History of prior bone disease (Paget's hyperparathyroidism, etc.)
- Active and/or history of coronary heart disease or stroke within the past year
- Postmenopausal women
- Men with known hypogonadism prior to SCI
- Anabolic therapy longer than six months duration after SCI
- Glucocorticoid administration longer than three months duration within the last year, and/or prescribed moderate or high dose corticosteroids (>40 mg/d prednisone or an equivalent dose of other corticosteroid medication) for longer than one week, not including drug administered to preserve neurological function at the time of acute SCI
- Endocrinopathies (hyperthyroidism, Cushing's disease or syndrome, etc.)
- Severe underlying chronic disease (e.g., COPD, end-stage heart disease, chronic renal failure)
- Heterotopic ossification (HO) of the knee region (the distal femoral epiphysis is the primary endpoint); HO to any other boney region will not prevent study participation as long as contraindicated medications have not been prescribed)
- Chronic alcohol abuse
- Hypocalcemia
- Pregnancy
- Prescribed a bisphosphonate for HO, or prescribed any other agent to treat osteoporosis other than calcium and vitamin D
- Electrical stimulation of the lower extremities
- Current diagnosis of cancer or history of cancer
- Osteosarcoma
- Life expectancy less than 5 years
Where it is running
- Kessler Institute for Rehabilitation — West Orange, New Jersey, United States
- James J. Peters VA Medical Center, Bronx, NY — The Bronx, New York, United States
Full record on ClinicalTrials.gov
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