Department of Orthopedic Surgery, Tokyo Women's Medical University, Tokyo, Japan.
Hasuda Hospital, Saitama, Japan.
Calcif Tissue Int. 2023 Aug;113(2):157-165. doi: 10.1007/s00223-023-01087-y. Epub 2023 May 3.
Romosozumab can increase bone mineral density (BMD) in patients with osteoporosis, but some patients do not respond to it. This study aimed to identify risk factors for being a nonresponder to romosozumab treatment. This retrospective observational study included 92 patients. Romosozumab (210 mg) was subcutaneously administered to the participants every 4 weeks over 12 months. We excluded patients who previously underwent treatment for osteoporosis to assess the impact of romosozumab alone. We evaluated the proportion of patients who did not respond to romosozumab treatment to the lumbar spine and hip with increased BMD. Nonresponders were defined as those with a bone density change of < 3% after 12 months of treatment. We compared demographics and biochemical markers between responders and nonresponders. We found that 11.5% of patients were nonresponders at the lumbar spine, and 56.8% were nonresponders at the hip. A risk factor for nonresponse at the spine was low type I procollagen N-terminal propeptide (P1NP) values at 1 month. The cutoff value for P1NP at month 1 was 50 ng/ml. We found that 11.5% and 56.8% of patients experienced no significant improvement in the lumbar spine and hip BMD, respectively. Clinicians should use nonresponse risk factors to inform decisions about romosozumab treatment for patients with osteoporosis.
罗莫佐单抗可增加骨质疏松症患者的骨密度(BMD),但部分患者对此无应答。本研究旨在确定对罗莫佐单抗治疗无应答的风险因素。这是一项回顾性观察性研究,共纳入 92 名患者。92 名患者接受了为期 12 个月、每 4 周皮下注射 210mg 罗莫佐单抗的治疗。我们排除了既往接受过骨质疏松症治疗的患者,以评估罗莫佐单抗单独治疗的影响。我们评估了 BMD 增加后腰椎和髋部对罗莫佐umab 治疗无应答的患者比例。无应答者定义为治疗 12 个月后骨密度变化<3%的患者。我们比较了应答者和无应答者之间的人口统计学和生化标志物。我们发现,11.5%的患者腰椎无应答,56.8%的患者髋部无应答。1 个月时低型 I 原胶原 N 端前肽(P1NP)值是脊柱无应答的风险因素。1 个月时 P1NP 的截断值为 50ng/ml。我们发现,11.5%和 56.8%的患者腰椎和髋部 BMD 分别无明显改善。临床医生应使用无应答风险因素来告知骨质疏松症患者罗莫佐单抗治疗的决策。