Abstract：
UNASSIGNED: This study aimed to assess the efficacy and safety of MW031 in Chinese postmenopausal women with osteoporosis.
UNASSIGNED: 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.
UNASSIGNED: Of 448 randomized patients, 421 completed the study (MW031, n = 322; placebo, n = 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% (p = 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.
UNASSIGNED: 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.
UNASSIGNED: NCT05215977 (ClinicalTrials.gov.).
UNASSIGNED: 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.
UNASSIGNED: Of 448 randomized patients, 421 completed the study (MW031, n = 322; placebo, n = 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% (p = 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.
UNASSIGNED: 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.
UNASSIGNED: NCT05215977 (ClinicalTrials.gov.).
摘要：
■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。
■在这个随机的，双盲,安慰剂对照,多中心临床试验，448名患有骨质疏松症的绝经后妇女被随机分为3：1，接受MW031和安慰剂，为期12个月。主要疗效终点是12个月腰椎BMD相对于基线的百分比变化。还包括安全性和免疫原性谱。
■在448名随机患者中，421完成研究（MW031，n=322；安慰剂，n=99)。MW031治疗12个月后，腰椎骨密度增加5.80%,在全髋关节3.65%，股骨颈处2.93%。模型调整后的差异为3.86%(P<0.0001),2.34%（P<0.0001），与安慰剂组相比为1.05%(p=0.08)，分别。对于骨转换标记，MW031组血清CTX水平下降至第1个月的最大差异（-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，两组之间报告任何不良事件的患者比例没有显着差异。
■这项研究表明，MW031安全有效地增加了中国绝经后骨质疏松症妇女的骨密度，并迅速降低了骨吸收标志物的水平。
■NCT05215977(ClinicalTrials.gov.)).
■在这个随机的，双盲,安慰剂对照,多中心临床试验，448名患有骨质疏松症的绝经后妇女被随机分为3：1，接受MW031和安慰剂，为期12个月。主要疗效终点是12个月腰椎BMD相对于基线的百分比变化。还包括安全性和免疫原性谱。
■在448名随机患者中，421完成研究（MW031，n=322；安慰剂，n=99)。MW031治疗12个月后，腰椎骨密度增加5.80%,在全髋关节3.65%，股骨颈处2.93%。模型调整后的差异为3.86%(P<0.0001),2.34%（P<0.0001），与安慰剂组相比为1.05%(p=0.08)，分别。对于骨转换标记，MW031组血清CTX水平下降至第1个月的最大差异（-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，两组之间报告任何不良事件的患者比例没有显着差异。
■这项研究表明，MW031安全有效地增加了中国绝经后骨质疏松症妇女的骨密度，并迅速降低了骨吸收标志物的水平。
■NCT05215977(ClinicalTrials.gov.)).
