Ishikawa Koji, Tani Soji, Toyone Tomoaki, Tsuchiya Koki, Towatari Tomoko, Oshita Yusuke, Yamamura Ryo, Wada Kazuki, Nagai Takashi, Shirahata Toshiyuki, Inagaki Katsunori, Yoshifumi Kudo
Department of Orthopaedic Surgery, School of Medicine Showa University Tokyo Japan.
Department of Orthopaedic Surgery Duke University Durham North Carolina USA.
JOR Spine. 2024 Aug 5;7(3):e1356. doi: 10.1002/jsp2.1356. eCollection 2024 Sep.
Age-related changes in bone health increase the risk for complications in elderly patients undergoing orthopedic surgery. Osteoporosis is a key therapeutic target that needs to be addressed to ensure successful instrumentation surgery. The effectiveness of pharmacological interventions in orthopedic surgery, particularly the new drug romosozumab, is still unknown. We aim to evaluate the effect of 3-month romosozumab treatment on biomechanical parameters related to spinal instrumentation surgery, using the Quantitative Computed Tomography (QCT)-based Finite Element Method (FEM).
This open-labeled, prospective study included 81 patients aged 60 to 90 years, who met the osteoporosis criteria and were scheduled for either romosozumab or eldecalcitol treatment. Patients were assessed using blood samples, dual-energy absorptiometry (DXA), and QCT. Biomechanical parameters were evaluated using FEM at baseline and 3 months post-treatment. The primary endpoints were biomechanical parameters at 3 months, while secondary endpoints included changes in regional volumetric bone mineral density around the pedicle (P-vBMD) and vertebral body (V-vBMD).
Romosozumab treatment led to significant gains in P-vBMD, and V-vBMD compared to eldecalcitol at 3 months. Notably, the romosozumab group showed greater improvements in all biomechanical parameters estimated by FEM at 3 months compared to the eldecalcitol group.
Romosozumab significantly increased the regional vBMD as well as biomechanical parameters, potentially offering clinical benefits in reducing post-operative complications in patients with osteoporosis undergoing orthopedic instrumentation surgery. This study highlights the novel advantages of romosozumab treatment and advocates further research on its effectiveness in perioperative management.
骨骼健康的年龄相关性变化增加了老年骨科手术患者发生并发症的风险。骨质疏松症是确保器械手术成功需要解决的关键治疗靶点。药物干预在骨科手术中的有效性，尤其是新药罗莫单抗，仍不清楚。我们旨在使用基于定量计算机断层扫描（QCT）的有限元方法（FEM），评估3个月罗莫单抗治疗对与脊柱器械手术相关的生物力学参数的影响。
这项开放标签的前瞻性研究纳入了81名年龄在60至90岁之间、符合骨质疏松症标准且计划接受罗莫单抗或阿法骨化醇治疗的患者。使用血液样本、双能X线吸收法（DXA）和QCT对患者进行评估。在基线和治疗后3个月使用FEM评估生物力学参数。主要终点是3个月时的生物力学参数，次要终点包括椎弓根周围区域体积骨密度（P-vBMD）和椎体（V-vBMD）的变化。
与阿法骨化醇相比，罗莫单抗治疗在3个月时导致P-vBMD和V-vBMD显著增加。值得注意的是，与阿法骨化醇组相比，罗莫单抗组在3个月时通过FEM估计的所有生物力学参数均有更大改善。
罗莫单抗显著增加了区域vBMD以及生物力学参数，可能为减少接受骨科器械手术的骨质疏松症患者术后并发症带来临床益处。本研究突出了罗莫单抗治疗的新优势，并提倡对其在围手术期管理中的有效性进行进一步研究。
