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A phase III randomized, double-blind, placebo-controlled trial of the denosumab biosimilar QL1206 in postmenopausal Chinese women with osteoporosis and high fracture risk

   
@article{APS10772,
	author = {Hao Zhang and Jie-mei Gu and Ai-jun Chao and Qun Cheng and Dong-hui Teng and Jin-ming Yu and Bing-wu Wang and Ya-nan Huo and Li Mao and Qiu Zhang and Hong Yang and Shi-gui Yan and Ke-qin Zhang and Xue-ling Zhao and Hua Lin and Yu Pei and Zhong Yuan and Ru-chun Dai and Liang He and Li Chen and Yong-feng Su and Zhong-liang Deng and Li You and Bo Ban and Mei Zhu and You-liang Cao and Yi-kun Zhu and Zhi-jun Li and Zhi Zhang and Cheng-qing Yi and Yi-bing Lu and Guang Wang and Cui-cui Han and Zhen-jiang Wang and Xian-xing Li and Zhen-lin Zhang},
	title = {A phase III randomized, double-blind, placebo-controlled trial of the denosumab biosimilar QL1206 in postmenopausal Chinese women with osteoporosis and high fracture risk},
	journal = {Acta Pharmacologica Sinica},
	volume = {44},
	number = {2},
	year = {2023},
	keywords = {},
	abstract = {The current study evaluated the efficacy and safety of a denosumab biosimilar, QL1206 (60 mg), compared to placebo in postmenopausal Chinese women with osteoporosis and high fracture risk. At 31 study centers in China, a total of 455 postmenopausal women with osteoporosis and high fracture risk were randomly assigned to receive QL1206 (60 mg subcutaneously every 6 months) or placebo. From baseline to the 12-month follow-up, the participants who received QL1206 showed significantly increased bone mineral density (BMD) values (mean difference and 95% CI) in the lumbar spine: 4.780% (3.880%, 5.681%), total hip :3.930% (3.136%, 4.725%), femoral neck 2.733% (1.877%, 3.589%) and trochanter: 4.058% (2.791%, 5.325%) compared with the participants who received the placebo. In addition, QL1206 injection significantly decreased the serum levels of C-terminal crosslinked telopeptides of type 1 collagen (CTX): −77.352% (−87.080%, −66.844%), and N-terminal procollagen of type l collagen (P1NP): −50.867% (−57.184%, −45.217%) compared with the placebo over the period from baseline to 12 months. No new or unexpected adverse events were observed. We concluded that compared with placebo, QL1206 effectively increased the BMD of the lumbar spine, total hip, femoral neck and trochanter in postmenopausal Chinese women with osteoporosis and rapidly decreased bone turnover markers. This study demonstrated that QL1206 has beneficial effects on postmenopausal Chinese women with osteoporosis and high fracture risk.},
	issn = {1745-7254},	url = {http://www.chinaphar.com/article/view/10772}
}