%0 Journal Article
%T A phase III randomized, double-blind, placebo-controlled trial of the denosumab biosimilar QL1206 in postmenopausal Chinese women with osteoporosis and high fracture risk
%A Zhang Hao
%A Gu Jie-mei
%A Chao Ai-jun
%A Cheng Qun
%A Teng Dong-hui
%A Yu Jin-ming
%A Wang Bing-wu
%A Huo Ya-nan
%A Mao Li
%A Zhang Qiu
%A Yang Hong
%A Yan Shi-gui
%A Zhang Ke-qin
%A Zhao Xue-ling
%A Lin Hua
%A Pei Yu
%A Yuan Zhong
%A Dai Ru-chun
%A He Liang
%A Chen Li
%A Su Yong-feng
%A Deng Zhong-liang
%A You Li
%A Ban Bo
%A Zhu Mei
%A Cao You-liang
%A Zhu Yi-kun
%A Li Zhi-jun
%A Zhang Zhi
%A Yi Cheng-qing
%A Lu Yi-bing
%A Wang Guang
%A Han Cui-cui
%A Wang Zhen-jiang
%A Li Xian-xing
%A Zhang Zhen-lin
%J Acta Pharmacologica Sinica
%D 2023
%B 2023
%9 
%! A phase III randomized, double-blind, placebo-controlled trial of the denosumab biosimilar QL1206 in postmenopausal Chinese women with osteoporosis and high fracture risk
%K 
%X 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.
%U http://www.chinaphar.com/article/view/10772
%V 44
%N 2
%P 446–453
%@ 1745-7254