Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI
Status:
Recruiting
Trial end date:
2024-08-01
Target enrollment:
Participant gender:
Summary
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.