Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI

Who is this study for? Patients with chronic spinal cord injury
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2

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 SCI and areal BMD (aBMD) values at the distal femur of at the distal femur 0.7 g/cm2 but 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.

Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: No

• Traumatic SCI [C4-T10 [upper motor lesions as determined by the International Standards for Neurological Classification for Spinal Cord Injury (ISNCSCI) impairment scale]; ISNCSCI score A & B

• Duration of injury 3 years

• Males and females (premenopausal) between the ages of 18 and 50 years old (the upper age limit is to reduce the influence of age on the ability of the skeleton to respond to pharmacologic stimulation)

• aBMD at the distal femur 0.7 g/cm2 but 1.0 g/cm2 (determined at screening)

United States
New Jersey
Kessler Institute for Rehabilitation
West Orange
New York
James J. Peters VA Medical Center, Bronx, NY
Contact Information
Dylan G Pryor, BS
(718) 584-9000
William A Bauman, MD
(718) 584-9000
Time Frame
Start Date: October 28, 2020
Estimated Completion Date: August 1, 2024
Target number of participants: 39
Experimental: Romosozumab Treatment (baseline to month 11)
Of the thirty-nine (39) individuals with chronic spinal cord injury (SCI) enrolled in this study, twenty-six (26) participants will be randomly selected to received romosozumab (210mg SQ) once a month for 12 months.
Placebo Comparator: Placebo (baseline to month 12)
Of the thirty-nine (39) individuals with chronic SCI enrolled in this study, thirteen (13) participants will be randomly selected to received placebo injections (NS SQ) once a month for 12 months. They will follow study procedures identical to those performed by individuals in the treatment (romosozumab) group.
Active Comparator: Denosumab (month 12 to month 24)
Both groups (treatment and placebo) will receive denosumab (60mg SQ) at months 12 and 18 for maintenance of or to further increase bone mineral density (BMD) at regions of interest (ROI).
William A. Bauman
Related Therapeutic Areas
Leads: VA Office of Research and Development
Collaborators: Kessler Institute for Rehabilitation

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