Department of Orthopedics, Inoue Hospital, Osaka, Japan.
Renal Center, Ohno Memorial Hospital, 1-26-10, Minami-Horie, Nishi-ku, Osaka, Osaka, 550-0015, Japan.
J Bone Miner Metab. 2021 Nov;39(6):1082-1090. doi: 10.1007/s00774-021-01253-y. Epub 2021 Jul 29.
Romosozumab reportedly increases bone mineral density (BMD) potently but might adversely affect cardiovascular disease (CVD). We evaluated the efficacy of romosozumab in osteoporotic HD patients with a high risk of fracture.
This was a single-center 1-year study in Japanese HD patients. Among 96 HD romosozumab-treated HD patients with high risk of fracture, 76 HD patients completed 1 year of subcutaneous administration of romosozumab (210 mg/4 weeks) for 1 year. Romosozumab-untreated HD patients (n = 55) were also included. Changes in BMD and serum markers, together with fracture occurrence, and CVD events, were monitored.
During romosozumab treatment of 76 HD patients, BMD time-dependently increased significantly by 15.3% ± 12.9% at the lumbar spine (L1-4), and 7.2% ± 8.3% at the femoral neck at 1 year. Serum BAP and total P1NP increased significantly and serum TRACP-5b decreased at 4 weeks. Fragility fractures occurred in three (3.8%) patients. Hypocalcemia occurred at 4-48 weeks despite the increased dosing of active vitamin-D derivatives, but without any symptom. New CVD events occurred in 5.2% of romosozumab-treated HD patients and10.9% in romosozumab-untreated HD patients.
BMD was increased significantly during romosozumab treatment at the lumbar spine, and the femoral neck, respectively, at 1 year in HD patients. Hypocalcemia occurred but without any intolerable event. There was no apparent increase in CVD events during 1 year of study, suggesting romosozumab as a promising agent for HD patients with severe osteoporosis.
罗莫索单抗据报道可强力增加骨密度（BMD），但可能对心血管疾病（CVD）产生不利影响。我们评估了罗莫索单抗在骨折风险较高的骨质疏松症 HD 患者中的疗效。
这是一项在日本 HD 患者中进行的为期 1 年的单中心研究。在 96 名接受罗莫索单抗治疗且骨折风险高的 HD 患者中，有 76 名 HD 患者完成了为期 1 年的皮下注射罗莫索单抗（210mg/4 周）。还纳入了未接受罗莫索单抗治疗的 HD 患者（n=55）。监测 BMD 的变化和血清标志物，以及骨折的发生和 CVD 事件。
在 76 名接受罗莫索单抗治疗的 HD 患者中，BMD 时间依赖性地显著增加，腰椎（L1-4）增加 15.3%±12.9%，股骨颈增加 7.2%±8.3%，1 年后。4 周时血清 BAP 和总 P1NP 显著增加，血清 TRACP-5b 减少。3 名（3.8%）患者发生脆性骨折。尽管增加了活性维生素 D 衍生物的剂量，但在 4-48 周时仍发生低钙血症，但无任何症状。罗莫索单抗治疗的 HD 患者中有 5.2%发生新的 CVD 事件，未接受罗莫索单抗治疗的 HD 患者中有 10.9%发生新的 CVD 事件。
在 HD 患者中，罗莫索单抗治疗 1 年后，腰椎和股骨颈的 BMD 分别显著增加。发生低钙血症，但无不可耐受的事件。在 1 年的研究期间，CVD 事件无明显增加，表明罗莫索单抗是一种有前途的治疗严重骨质疏松症 HD 患者的药物。
