Clinical Sciences/Health Conditions
Saina Aliabadi, PhD
PhD Candidate
University Health Network
ROCHESTER, New York, United States
Sander Hitzig, PhD
Senior Scientist
Sunnybrook Research Institute
Toronto, Ontario, Canada
Beverley Craven, MD, MSc, FRCPC
Professor
University of Toronto – Temerty Faculty of Medicine, Department of Medicine
Toronto, Ontario, Canada
Adults with chronic spinal cord injury (cSCI) often develop sublesional osteoporosis and have a high risk of lower extremity fragility fractures. Denosumab, a RANKL inhibitor, may improve areal bone mineral density (aBMD) and reduce fractures; however, evidence for use in adults with cSCI is limited.
We describe the effectiveness and safety of Denosumab for the treatment of low proximal tibia aBMD in a cohort of adults with cSCI.
Design:
We retrospectively compared data from n=43 adults with cSCI who received 3 doses of Denosumab versus adults with SCI who received > 3 doses of Denosumab with calcium and vitamin D. Data were abstracted from health records, including demographic and impairment characteristics, pharmacy dispensing, and absolute changes in aBMD (proximal tibia, distal femur, and total hip) from baseline. Adverse events and fracture risk (FRAX) were documented.
Results:
Adult participants (mean age: 59.28 years, 65.12% male, 65.1% complete SCI) with a mean injury duration of 27.93 years. No statistically significant differences were detected in the change in proximal tibia, distal femur, or total hip aBMD between individuals who received 3 doses of Denosumab and those who received > 3 doses (all p values > 0.14). FRAX-based fracture risk was generally low/moderate, and no new fragility fractures were reported among the cohort after Denosumab therapy. Adverse events were rare and mostly mild (e.g., skin rashes, cellulitis, and muscle aches)
Conclusion:
This preliminary analysis of retrospective cohort data, among adults with chronic SCI, exposed to 3 or more doses of Denosumab, indicates that this therapy was safe and well-tolerated, with no subsequent fragility fractures and mild adverse events reported. While differences in aBMD outcomes between dose groups were not significant, the results may be influenced by sample size limitations; additional participants may clarify the associations between drug exposure and changes in proximal tibia aBMD.
