Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2023 Feb;44(2):446-453.
doi: 10.1038/s41401-022-00954-y. Epub 2022 Jul 27.

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

Hao Zhang #  1 , Jie-Mei Gu #  1 , Ai-Jun Chao  2 , Qun Cheng  3 , Dong-Hui Teng  4 , Jin-Ming Yu  5 , Bing-Wu Wang  6 , Ya-Nan Huo  7 , Li Mao  8 , Qiu Zhang  9 , Hong Yang  10 , Shi-Gui Yan  11 , Ke-Qin Zhang  12 , Xue-Ling Zhao  13 , Hua Lin  14 , Yu Pei  15 , Zhong Yuan  16 , Ru-Chun Dai  17 , Liang He  18 , Li Chen  19 , Yong-Feng Su  20 , Zhong-Liang Deng  21 , Li You  22 , Bo Ban  23 , Mei Zhu  24 , You-Liang Cao  25 , Yi-Kun Zhu  26 , Zhi-Jun Li  27 , Zhi Zhang  28 , Cheng-Qing Yi  29 , Yi-Bing Lu  30 , Guang Wang  31 , Cui-Cui Han  32 , Zhen-Jiang Wang  33 , Xian-Xing Li  34 , Zhen-Lin Zhang  35
Affiliations
Clinical Trial

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

Hao Zhang et al. Acta Pharmacol Sin. 2023 Feb.

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.

Keywords: Chinese women; adverse events; bone mineral density; bone turnover markers; denosumab biosimilar; postmenopausal osteoporosis.

PubMed Disclaimer

Conflict of interest statement

CCH, ZJW, and XXL are employees of the study sponsor (Qilu Pharmaceutical Co., Ltd) at the time of study. The other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1. Disposition of study subjects.
IP investigational product, FAS full analysis set. Asterisk symbol (*) indicates, one subject was excluded due to lack of efficacy data after IP administration.
Fig. 2
Fig. 2. Percent changes in bone mineral density.
Mean percent change from baseline to specific timepoints in bone mineral density (BMD) at lumbar spine (L1–L4) (a), total hip (b), femoral neck (c) and trochanter (d).
Fig. 3
Fig. 3. Percent changes in biochemical markers of bone metabolism.
Mean percent change from baseline to specific timepoints in serum CTX (a), P1NP (b), calcium (c) and phosphorus (d).
See this image and copyright information in PMC

References

    1. NIH Consensus Development Panel on Osteoporosis Prevention, Diagnosis, and Therapy Osteoporosis prevention, diagnosis, and therapy. JAMA. 2001;285:785–95. doi: 10.1001/jama.285.6.785. - DOI - PubMed
    1. Compston JE, McClung MR, Leslie WD. Osteoporosis. Lancet. 2019;393:364–76. doi: 10.1016/S0140-6736(18)32112-3. - DOI - PubMed
    1. Wang Y, Tao Y, Hyman ME, Li J, Chen Y. Osteoporosis in China. Osteoporos Int. 2009;20:1651–62. doi: 10.1007/s00198-009-0925-y. - DOI - PubMed
    1. Gao C, Xu Y, Li L, Gu WQ, Yi CT, Zhu Q, et al. Prevalence of osteoporotic vertebral fracture among community-dwelling elderly in Shanghai. Chin Med J. 2019;132:1749–51. doi: 10.1097/CM9.0000000000000332. - DOI - PMC - PubMed
    1. Xia WB, He SL, Xu L, Liu AM, Jiang Y, Li M, et al. Rapidly increasing rates of hip fracture in Beijing, China. J Bone Min Res. 2012;27:125–9. doi: 10.1002/jbmr.519. - DOI - PubMed

Publication types