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

Acta Pharmacol Sin. 2023 Feb;44(2):446-453. doi: 10.1038/s41401-022-00954-y. Epub 2022 Jul 27.

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.

Publication types

  • Randomized Controlled Trial
  • Clinical Trial, Phase III

MeSH terms

  • Biosimilar Pharmaceuticals* / adverse effects
  • Bone Density
  • Bone Density Conservation Agents* / therapeutic use
  • Bone Remodeling
  • Denosumab / pharmacology
  • Denosumab / therapeutic use
  • Double-Blind Method
  • East Asian People
  • Female
  • Humans
  • Osteoporosis* / drug therapy
  • Osteoporosis, Postmenopausal* / complications
  • Osteoporosis, Postmenopausal* / drug therapy
  • Postmenopause

Substances

  • Biosimilar Pharmaceuticals
  • Bone Density Conservation Agents
  • Denosumab
  • QL1206