Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Department of Endocrinology and Metabolism, Ajou University Hospital, Suwon, Korea.
Endocrinol Metab (Seoul). 2021 Feb;36(1):60-69. doi: 10.3803/EnM.2020.848. Epub 2021 Feb 24.
This phase 3 study evaluated the efficacy and safety of 6-month treatment with romosozumab in Korean postmenopausal women with osteoporosis.
Sixty-seven postmenopausal women with osteoporosis (bone mineral density [BMD] T-scores ≤-2.5 at the lumbar spine, total hip, or femoral neck) were randomized (1:1) to receive monthly subcutaneous injections of romosozumab (210 mg; n=34) or placebo (n=33) for 6 months.
At month 6, the difference in the least square (LS) mean percent change from baseline in lumbar spine BMD (primary efficacy endpoint) between the romosozumab (9.5%) and placebo (-0.1%) groups was significant (9.6%; 95% confidence interval, 7.6 to 11.5; P<0.001). The difference in the LS mean percent change from baseline was also significant for total hip and femoral neck BMD (secondary efficacy endpoints). After treatment with romosozumab, the percent change from baseline in procollagen type 1 N-terminal propeptide transiently increased at months 1 and 3, while that in C-terminal telopeptide of type 1 collagen showed a sustained decrease. No events of cancer, hypocalcemia, injection site reaction, positively adjudicated atypical femoral fracture or osteonecrosis of the jaw, or positively adjudicated serious cardiovascular adverse events were observed. At month 9, 17.6% and 2.9% of patients in the romosozumab group developed binding and neutralizing antibodies, respectively.
Treatment with romosozumab for 6 months was well tolerated and significantly increased lumbar spine, total hip, and femoral neck BMD compared with placebo in Korean postmenopausal women with osteoporosis (ClinicalTrials.gov identifier NCT02791516).
本 3 期研究评估了罗莫佐单抗在韩国绝经后骨质疏松症女性中进行 6 个月治疗的疗效和安全性。
67 名绝经后骨质疏松症患者（骨密度 [BMD] T 评分在腰椎、全髋或股骨颈处≤-2.5）被随机（1:1）分为罗莫佐单抗（210mg；n=34）或安慰剂（n=33）组，每月接受一次皮下注射，共 6 个月。
在第 6 个月，罗莫佐单抗（9.5%）与安慰剂（-0.1%）组之间，从基线开始的腰椎 BMD 最小平方（LS）均值百分比变化的差异有统计学意义（9.6%；95%置信区间，7.6 至 11.5；P<0.001）。总髋部和股骨颈 BMD（次要疗效终点）的 LS 均值百分比变化差异也有统计学意义。罗莫佐单抗治疗后，I 型前胶原 N 端前肽的基线百分比变化在第 1 个月和第 3 个月暂时增加，而 I 型胶原 C 端肽的变化则持续减少。未观察到癌症、低钙血症、注射部位反应、经判定的非典型股骨骨折或颌骨骨坏死、或经判定的严重心血管不良事件。在第 9 个月，罗莫佐单抗组分别有 17.6%和 2.9%的患者产生了结合抗体和中和抗体。
罗莫佐单抗治疗 6 个月耐受性良好，与安慰剂相比，可显著增加韩国绝经后骨质疏松症女性的腰椎、全髋和股骨颈 BMD（ClinicalTrials.gov 标识符 NCT02791516）。
