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Denosumab biosimilar QL1206 was effective and safe to treat women with osteoporosis during postmenopausal period.
In a study published in “Acta Pharmacologica Sinica”, 60 mg subcutaneously administered QL1206 showed positive outcomes in postmenopausal females. The aim of this phase III, double-blind, randomized, placebo-controlled trial was to investigate safety and efficacy of Denosumab biosimilar QL1206 in comparison to placebo in 455 postmenopausal females suffering from osteoporosis and elevated risk of fracture.
Participants were randomly assigned and administered with placebo or QL1206 (60 mg subcutaneously) every 6 months. Compared to placebo-recipients, those who received QL1206 had significantly higher bone mineral density (BMD) values (mean difference and 95% CI) at 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%]) from baseline to the 12-month follow-up.
Additionally, over the course of baseline to 12 months, QL1206 injection effectively reduced serum levels of C-terminal cross-linked telopeptides of type 1 collagen: -77.352% (-87.080%, -66.844%), and procollagen type l N-terminal propeptide (P1NP): -50.867% (-57.184%, -45.217%) in comparison to placebo.
There were no new or unanticipated negative events found. In postmenopausal females with osteoporosis, QL1206 successfully increased BMD of the lumbar spine, femoral neck, whole hip, and trochanter while rapidly lowering markers of bone turnover. Thus, QL1206 is useful for postmenopausal women who have osteoporosis and a high risk of fracture.
Acta Pharmacologica Sinica
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.
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