Abstract Preventing subsequent fractures after vertebral augmentation is a critical clinical concern. The purpose of this study was to compare the effect of romosozumab and bisphosphonate administration on the occurrence of subsequent vertebral fractures after balloon kyphoplasty (BKP) and to identify factors associated with the occurrence of subsequent vertebral fractures. The study compared 24 patients who underwent BKP and received romosozumab with 58 control patients who underwent BKP and received bisphosphonates, all within two months of acute osteoporotic vertebral fracture and showing unfavorable MRI prognostic factors. The primary outcome was the occurrence of subsequent fracture, and the secondary outcomes were improvement in back pain visual analog scale (VAS) score. Furthermore, logistic regression analysis was conducted to adjust for confounding factors and assess the effect of osteoporosis treatment type on subsequent vertebral fractures following BKP. Subsequent vertebral fractures occurred in 16 patients in the bisphosphonate group and in one patient in the romosozumab group (P=.02). There were no significant differences between the two groups in VAS scores and their change from preoperatively to 6 months after surgery. The multivariable logistic regression analysis identified the type of osteoporosis treatment as an independent factor associated with the occurrence of subsequent vertebral fractures (Odds ratio, 18.30, P=.02). This prospective, multicenter study demonstrates that romosozumab is more effective than bisphosphonates in preventing subsequent vertebral fractures within six months after BKP. Romosozumab’s superior efficacy in reducing subsequent vertebral fractures may lead to improved long-term outcomes and quality of life, potentially making it a preferred treatment option over bisphosphonates for patients undergoing BKP.
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