Teraguchi Masatoshi, Kitayama Yorihide, Yamada Yuki, Nakamoto Zyun, Yamaoka Yoshiyuki, Yamada Hiroshi
Department of Orthopaedic Surgery, Wakayama Medical University, Wakayama 641-8509, Japan.
Chuki Clinic, Wakayama 649-1342, Japan.
JBMR Plus. 2025 Jun 4;9(8):ziaf096. doi: 10.1093/jbmrpl/ziaf096. eCollection 2025 Aug.
This study aimed to evaluate and compare the efficacy and safety of romosozumab vs denosumab in hemodialysis (HD) patients with osteoporosis. A 12-mo observational study was conducted involving HD patients with osteoporosis at a single dialysis center. The study compared outcomes between 2 treatment groups: romosozumab (210 mg monthly, = 21) and denosumab (60 mg every 6 mo, = 24). Treatment allocation was based on cardiovascular history. Changes in bone mineral density (BMD), bone turnover markers (P1NP, TRACP-5b, and intact PTH), complications, and fractures were assessed. Serum calcium levels were monitored weekly. After 12 mo, patients receiving romosozumab showed significantly greater improvements in lumbar spine (LS) BMD compared to denosumab (14.6% vs 6.3%, < .05). Both treatments demonstrated comparable increases in femoral neck (FN) BMD (4.3% vs 6.0%, = .41). Bone turnover markers showed distinct patterns between groups, with romosozumab producing more pronounced early effects. P1NP levels increased significantly in the romosozumab group at 6 mo (+41.2%) before declining toward baseline, while showing sustained suppression in the denosumab group. The incidence of osteoporotic fractures was one case per group (vertebral fracture in romosozumab group, hip fracture in denosumab group). One case of injection site reactions was observed in the romosozumab group. Mean serum calcium levels remained stable in both groups throughout the study period. The treatment of romosozumab appears to be more effective than denosumab for improving BMD in HD patients with osteoporosis, particularly at the LS. Both treatment approaches demonstrated acceptable safety profiles, though careful monitoring of calcium levels and cardiovascular status is recommended.
本研究旨在评估和比较罗莫佐单抗与地诺单抗在骨质疏松症血液透析（HD）患者中的疗效和安全性。在一个单一透析中心对患有骨质疏松症的HD患者进行了一项为期12个月的观察性研究。该研究比较了两个治疗组的结果：罗莫佐单抗（每月210mg，n = 21）和地诺单抗（每6个月60mg，n = 24）。治疗分配基于心血管病史。评估骨矿物质密度（BMD）、骨转换标志物（P1NP、TRACP-5b和完整甲状旁腺激素）、并发症和骨折的变化。每周监测血清钙水平。12个月后，与地诺单抗相比，接受罗莫佐单抗治疗的患者腰椎（LS）BMD改善显著更大（14.6%对6.3%，P <.05）。两种治疗方法在股骨颈（FN）BMD方面显示出相当的增加（4.3%对6.0%，P =.41）。骨转换标志物在两组之间呈现出不同的模式，罗莫佐单抗产生更明显的早期效果。罗莫佐单抗组在6个月时P1NP水平显著升高（+41.2%），然后向基线下降，而地诺单抗组则持续受到抑制。骨质疏松性骨折的发生率每组1例（罗莫佐单抗组为椎体骨折，地诺单抗组为髋部骨折）。罗莫佐单抗组观察到1例注射部位反应。在整个研究期间，两组的平均血清钙水平均保持稳定。对于改善骨质疏松症HD患者的BMD，罗莫佐单抗治疗似乎比地诺单抗更有效，尤其是在腰椎。两种治疗方法均显示出可接受的安全性，不过建议仔细监测钙水平和心血管状况。
