Comparison of the Efficacy of Denosumab in Patients at High or Very High Risk of Osteoporotic Fractures

초록

Study Design: Retrospective cohort study Objectives: This study aimed to compare the efficacy of denosumab in osteoporosis between high-risk and very high-risk fracture patients Summary of Literature Review: Despite the updated AACE/ACE 2020 definitions for very high fracture risk, comparative outcome data between high-risk (HR) and very high-risk (VHR) osteoporosis groups remain limited. Materials and Methods: A retrospective analysis was performed on 332 patients who received denosumab treatment for osteoporosis between January 2019 and December 2022. Patients were classified as VHR if they met any of the following criteria: (1) bone mineral density (BMD) T-score below –3.0, (2) fracture while on osteoporosis therapy, (3) multiple fractures, or (4) fracture within the past 12 months. Patients with a single osteoporotic fracture who did not meet these criteria were classified as HR. Cases of secondary osteoporosis were excluded. During the study period, a subcutaneous injection of 60 mg of denosumab was administered every 6 months. BMD, bone turnover markers, serum biochemistry, and the incidence of new fractures and adverse effects were compared between the two groups. Results: The HR group included 105 patients and the VHR group 227 patients, with a mean age of 74.3 years and a mean follow-up period of 18.6 months. A significant difference in baseline BMD T-scores was observed between the two groups. The mean BMD T-scores for the lumbar spine and femur improved by 19.9% (–2.61 to –2.09, p<0.05) and 17.2% (–2.62 to –2.17, p<0.05), respectively. Serum parathyroid hormone levels were higher in the VHR group. At final follow-up, mean BMD T-scores of the lumbar spine and femur increased in both groups, but there was no difference in the magnitude of change between groups. CTX and ALP were significantly suppressed in the VHR group. Each group experienced five new fractures, and no adverse reactions were reported. Conclusions: Denosumab increased lumbar spine and femoral BMD in both HR and VHR groups, with no significant difference in the extent of change between groups. However, suppression of BTM was more pronounced in the VHR group. © 2025 Korean Society of Spine Surgery.

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