Mun Hyun Woong, Lee Jong Joo, Shin Hyun Chul, Kim Tae-Hwan, Kim Seok Woo, Oh Jae Keun
Department of Neurosurgery, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
Department of Orthopaedics, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea.
Neurospine. 2025 Mar;22(1):69-77. doi: 10.14245/ns.2449228.614. Epub 2025 Mar 31.
This study aimed to compare the efficacy and safety of romosozumab, a bone anabolic agent, versus vertebroplasty, a conventional surgical intervention, in treating osteoporotic vertebral compression fractures (OVCFs).
A retrospective analysis included 86 thoracic/lumbar compression fracture patients from 2014 to 2022 at a medical center. Forty-two patients received romosozumab (monthly injections for 1 year) followed by 1 year of denosumab, while 44 underwent vertebroplasty followed by denosumab injections biannually for 2 years. Outcomes were assessed using the Numerical Rating Scale (NRS) for pain, bone mineral density (BMD), vertebral compression ratio, and Cobb angle over 12 months.
At 12 months, the romosozumab group showed a greater reduction in NRS scores (4.90 ± 1.01 vs. 4.27 ± 1.34, p = 0.015) and a higher increase in lumbar BMD (0.8 ± 0.5 vs. 0.5 ± 0.3, p = 0.000) compared to the vertebroplasty group. There were no significant differences in changes in hip total BMD and femur neck BMD (p = 0.190, p = 0.167, respectively). Radiographic assessments showed no significant differences in vertebral compression ratio (14.7% vs. 14.8%; p = 0.960) or Cobb angle (4.2° vs. 4.9°; p = 0.302). The incidence of major osteoporotic fractures was lower in the romosozumab group (7.1% vs. 25.0%, p = 0.051), with similar rates of cardiovascular events in both groups (4.8% vs. 9.1%, p = 0.716).
Romosozumab has demonstrated superior pain reduction and lumbar BMD improvement compared to vertebroplasty at 12 months, with no significant differences in radiographic outcomes or adverse events, suggesting it as an alternative to vertebroplasty for OVCF.
本研究旨在比较骨合成代谢药物罗莫佐单抗与传统手术干预椎体成形术在治疗骨质疏松性椎体压缩骨折（OVCF）方面的疗效和安全性。
一项回顾性分析纳入了2014年至2022年在一家医疗中心的86例胸腰椎压缩骨折患者。42例患者接受罗莫佐单抗治疗（每月注射1年），随后接受1年的地诺单抗治疗，而44例患者接受椎体成形术，随后每半年注射地诺单抗2年。使用数字疼痛评分量表（NRS）评估疼痛、骨密度（BMD）、椎体压缩率和12个月内的Cobb角。
在12个月时，与椎体成形术组相比，罗莫佐单抗组的NRS评分降低幅度更大（4.90±1.01对4.27±1.34，p=0.015），腰椎骨密度增加更高（0.8±0.5对0.5±0.3，p=0.000）。髋部总骨密度和股骨颈骨密度变化无显著差异（分别为p=0.190，p=0.167）。影像学评估显示椎体压缩率（14.7%对14.8%；p=0.960）或Cobb角（4.2°对4.9°；p=0.302）无显著差异。罗莫佐单抗组主要骨质疏松性骨折的发生率较低（7.1%对25.0%，p=0.051），两组心血管事件发生率相似（4.8%对9.1%，p=0.716）。
与椎体成形术相比，罗莫佐单抗在12个月时显示出更好的疼痛缓解和腰椎骨密度改善，影像学结果或不良事件无显著差异，表明它可作为OVCF椎体成形术的替代方案。
