Department of Endocrinology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, PR China.
Department of Endocrinology, The Jiangxi Provincial People's Hospital, Nanchang, PR China.
Expert Opin Biol Ther. 2024 Jul;24(7):665-672. doi: 10.1080/14712598.2024.2352587. Epub 2024 May 16.
This study aimed to assess the efficacy and safety of MW031 in Chinese postmenopausal women with osteoporosis.
In this randomized, double-blind, placebo-controlled, multicenter clinical trial, 448 postmenopausal women with osteoporosis were randomized 3:1 to receive MW031 and placebo for 12 months. The primary efficacy endpoint was the percentage change from baseline in BMD at lumbar spine in month 12. The safety and immunogenicity profiles were also included.
Of 448 randomized patients, 421 completed the study (MW031, = 322; placebo, = 99).After 12 months of MW031 treatment, BMD increased by 5.80% at lumbar spine,3.65% at total hip, and 2.93% at femoral neck. The model-adjusted difference was 3.86% (P<0.0001), 2.34% (P<0.0001), and 1.05% ( = 0.08) compared with placebo group, respectively. For the bone turnover markers, serum CTX level in MW031 group decreased to the maximum difference in month 1 (-71.71%, 95% CI: -77.83%, -65.60%, P<0.0001) compared with the placebo group. The safety analysis showed no significant differences in the proportion of patients reporting any adverse events between the two groups.
This study demonstrated that MW031 safely and effectively increased BMD and rapidly decreased the level of bone resorption marker in Chinese postmenopausal women with osteoporosis.
NCT05215977 (ClinicalTrials.gov.).
本研究旨在评估 MW031 在中国绝经后骨质疏松症妇女中的疗效和安全性。
在这项随机、双盲、安慰剂对照、多中心临床试验中，448 例绝经后骨质疏松症患者以 3:1 的比例随机接受 MW031 和安慰剂治疗 12 个月。主要疗效终点是第 12 个月时腰椎骨密度相对于基线的变化百分比。还包括安全性和免疫原性概况。
在 448 例随机患者中，421 例完成了研究（MW031，n=322；安慰剂，n=99）。MW031 治疗 12 个月后，腰椎骨密度增加 5.80%，全髋骨密度增加 3.65%，股骨颈骨密度增加 2.93%。模型调整后的差异分别为 3.86%（P<0.0001）、2.34%（P<0.0001）和 1.05%（ = 0.08）与安慰剂组相比。对于骨转换标志物，MW031 组的血清 CTX 水平在第 1 个月下降至最大差异（-71.71%，95%CI：-77.83%，-65.60%，P<0.0001）与安慰剂组相比。安全性分析显示，两组患者报告任何不良事件的比例无显著差异。
这项研究表明，MW031 在中国绝经后骨质疏松症妇女中安全有效，可增加骨密度，并迅速降低骨吸收标志物水平。
NCT05215977（ClinicalTrials.gov）。
