Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

March 1, 2021

Primary Completion Date

February 5, 2026

Study Completion Date

March 1, 2027

Conditions
Spinal Cord Injury (=3 Years)Sublesional Bone Loss Secondary to SCI
Interventions
DRUG

Romosozumab

39 subjects with chronic SCI will be studied with a 2:1 ratio of randomization of drug to placebo. Romosozumab (210mg SQ) will be administered once a month for 12 months. Participants will arrive at the JJPVAMC or KIR once a month to receive injections of romosozumab or placebo. A designated unblinded healthcare professional will be responsible for administering these injections.

DRUG

Denosumab

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. Denosumab will be administered to both groups (treatment and placebo) for an additional 12 months. Participants will be asked to arrive at the JJPVAMC once every 6 months to receive injections of denosumab by a healthcare professional.

DRUG

Placebo

Thirteen (13) of the thirty-nine (39) subjects enrolled in this study will be randomly selected to receive placebo (NS SQ) injections for 12 months (baseline - month 11). The placebo injections will be administered by an unblinded healthcare professional (registered nurse / physician). Participants will be blinded to their group assignment (romosozumab treatment or placebo).

Trial Locations (2)

07052

Kessler Institute for Rehabilitation, West Orange

10468-3904

James J. Peters VA Medical Center, Bronx, NY, The Bronx

All Listed Sponsors
collaborator

Kessler Institute for Rehabilitation

INDUSTRY

lead

VA Office of Research and Development

FED