{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["44(2)"],"submitter":["Zhang H"],"pubmed_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 injec"],"journal":["Acta pharmacologica Sinica"],"pagination":["446-453"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9889741"],"repository":["biostudies-literature"],"pubmed_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."],"pmcid":["PMC9889741"],"pubmed_authors":["Lu YB","Yan SG","Deng ZL","Zhang H","Yi CQ","Wang G","Gu JM","Li ZJ","Wang ZJ","Mao L","Han CC","Zhang Q","Zhang KQ","Huo YN","Cheng Q","Yuan Z","Ban B","Yang H","Chen L","Zhu YK","Zhao XL","He L","Su YF","You L","Zhu M","Wang BW","Zhang ZL","Chao AJ","Dai RC","Zhang Z","Teng DH","Lin H","Pei Y","Yu JM","Cao YL","Li XX"],"additional_accession":[]},"is_claimable":false,"name":"A phase III randomized, double-blind, placebo-controlled trial of the denosumab biosimilar QL1206 in postmenopausal Chinese women with osteoporosis and high fracture risk.","description":"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 injec","dates":{"release":"2023-01-01T00:00:00Z","publication":"2023 Feb","modification":"2025-04-26T11:56:50.704Z","creation":"2025-02-19T04:59:53.236Z"},"accession":"S-EPMC9889741","cross_references":{"pubmed":["35896694"],"doi":["10.1038/s41401-022-00954-y"]}}