Abstract
OBJECTIVE: To evaluate the effects of denosumab on bone mineral density (BMD), fracture healing, recurrent-fracture risk, pain, and safety in patients with osteoporotic fractures. METHODS: This retrospective cohort study included 216 patients with osteoporotic fractures treated between January 2019 and June 2023. Patients received either denosumab (60 mg subcutaneously every 6 months; n = 113) or zoledronic acid (5 mg intravenously once annually; n = 103), alongside calcium and calcitriol supplementation. The primary endpoint was the change in lumbar-spine, femoral-neck, and total-hip BMD at 6 and 12 months. Secondary endpoints included serum bone-turnover markers [C-terminal telopeptide of type I collagen (CTX), bone-specific alkaline phosphatase (BALP), procollagen type I N-terminal propeptide (P1NP)], fracture-healing time, 12-month recurrent fracture incidence, pain intensity [Visual Analog Scale (VAS)], function by the Oswestry Disability Index (ODI), analgesic use, and adverse events. Pearson correlation was used to evaluate associations between bone turnover markers and BMD. RESULTS: At 12 months, denosumab significantly increased lumbar-spine, femoral-neck, and total-hip BMD compared to zoledronic acid (P < 0.05). CTX and P1NP were significantly lower after 6 and 12 months (P < 0.05) and were inversely correlated with BMD gains (P < 0.05), while BALP showed no correlation. Denosumab significantly shortened fracture-healing time (P < 0.05), improved complete-healing rate (P < 0.05), and reduced recurrence (P < 0.05). VAS, ODI, and analgesic use were all lower in the denosumab group (P < 0.05). The incidence of adverse events was comparable between the two groups (P > 0.05). CONCLUSION: Denosumab substantially enhanced BMD, accelerated fracture healing, reduced recurrent fracture risk, and alleviated pain in patients with osteoporotic fracture, with a safety profile comparable to zoledronic acid.