spinal cord injury research

Treatment of Bone Loss in Persons with Chronic Spinal Cord Injury

The purpose of this study is to determine the usefulness of taking Romosozumab for 1 year compared to a placebo (salt solution) followed by 1 year of Denosumab in those who had a spinal cord injury longer than 3 years. Romosozumab and Denosumab are both FDA approved drugs to treat osteoporosis (thinning and weakening of the bone) in those at risk for fracture.

Actively Recruiting
Yes
Duration

Participation lasts approximately 24 months including 14 visits to Kessler Institute of Rehabilitation in West Orange for medication (12 visits for romosozumab or placebo injections, then an additional 2 visits for denosumab). Some of the visits include bone scans and blood tests. Each study visit lasts 1-4.5 hours depending on the number of tests that need to be completed during those sessions. 

Inclusion Criteria
  • Individuals diagnosed with a complete or incomplete SCI C4 and below (upper motor lesions, AIS grade A-C, wheelchair dependent greater than 75% of the time)
  • SCI occurred 3-15 years ago
  • Males and premenopausal females age 18-50 years
  • aBMD (areal bone mineral density) at the distal femur greater than or equal to 0.6 g/cm² but less than or equal to 1.0 g/cm² as determined by study staff.
Compensation

Participants who complete the study receive $550. 

Research Categories
Spinal Cord Injury
IRB Number:

D-1101-20