Inose Hiroyuki, Takahashi Shinji, Teraguchi Masatoshi, Kato Tsuyoshi, Yamada Kentaro, Yasuda Hiroyuki, Terakawa Masaki, Minetama Masakazu, Tomori Masaki, Nakagawa Yukihiro, Yoshii Toshitaka
Department of Orthopaedic Surgery, Dokkyo Medical University Saitama Medical Center, Saitama 343-8555, Japan.
Department of Orthopedics, Institute of Science Tokyo, Tokyo 113-8519, Japan.
JBMR Plus. 2024 Oct 29;9(1):ziae137. doi: 10.1093/jbmrpl/ziae137. eCollection 2025 Jan.
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 2 months of acute osteoporotic vertebral fracture and showing unfavorable magnetic resonance imaging 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 1 patient in the romosozumab group ( = .02). There were no significant differences between the 2 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, = .02). This prospective, multicenter study demonstrates that romosozumab is more effective than bisphosphonates in preventing subsequent vertebral fractures within 6 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.
预防椎体强化术后的再次骨折是一个关键的临床问题。本研究的目的是比较罗莫单抗和双膦酸盐给药对球囊椎体后凸成形术（BKP）后再次椎体骨折发生情况的影响，并确定与再次椎体骨折发生相关的因素。该研究比较了24例接受BKP并接受罗莫单抗治疗的患者与58例接受BKP并接受双膦酸盐治疗的对照患者，所有患者均在急性骨质疏松性椎体骨折后2个月内，且磁共振成像预后因素不佳。主要结局是再次骨折的发生，次要结局是背痛视觉模拟量表（VAS）评分的改善。此外，进行逻辑回归分析以调整混杂因素，并评估骨质疏松症治疗类型对BKP后再次椎体骨折的影响。双膦酸盐组有16例患者发生再次椎体骨折，罗莫单抗组有1例患者发生再次椎体骨折（P = 0.02）。两组在VAS评分及其从术前到术后6个月的变化方面无显著差异。多变量逻辑回归分析确定骨质疏松症治疗类型是与再次椎体骨折发生相关的独立因素（优势比，18.30，P = 0.02）。这项前瞻性、多中心研究表明，在预防BKP后6个月内的再次椎体骨折方面，罗莫单抗比双膦酸盐更有效。罗莫单抗在减少再次椎体骨折方面的卓越疗效可能会改善长期结局和生活质量，这可能使其成为接受BKP患者优于双膦酸盐的首选治疗选择。
