Efficacy, pharmacodynamics, pharmacokinetics, safety, and immunogenicity of Bmab 1000 vs reference denosumab: 78-wk results from a randomized, double-blind, multicenter, parallel-arm Phase 3 trial (DEVOTE) in women with postmenopausal osteoporosis
Abstract
This randomized, double-blind, multicenter Phase 3 trial evaluated the efficacy, safety, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of Bmab 1000 vs reference denosumab in 479 women with postmenopausal osteoporosis. Participants (mean age 66.6 yr; lumbar spine T-score ≤-2.5 to ≥-4.0) were randomized 1:1 to receive 60 mg Bmab 1000 (n = 238) or reference denosumab (n = 241) subcutaneously. The study comprised 2 parts: Part 1 (weeks 0-52) evaluated therapeutic and PD equivalence between Bmab 1000 and reference denosumab using percentage change from baseline (%CfB) in lumbar spine bone mineral density (BMD) at week 52 and area under the effect curve (AUEC) of serum C-terminal telopeptide of Type 1 collagen (sCTX) from baseline to 26 wk following dosing on day 1 and week 26. Part 2 (weeks 52-78) re-randomized those on reference denosumab to either continue or switch to Bmab 1000 (n = 104 each), while those on Bmab 1000 continued treatment (n = 218). Part 2 monitored the safety of Bmab 1000 and reference denosumab after transition from reference denosumab to Bmab 1000 vs continuing reference denosumab. Secondary analyses included additional efficacy, PD, PK, safety, and immunogenicity parameters. At week 52, the confidence intervals (CIs) for the difference in least square means (LSMs) in %CfB in lumbar spine BMD between Bmab 1000 and reference denosumab were contained within the predefined margins (±1.45; LSM diff: 0.610, 95% CI: -0.095, 1.316), indicating…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 479 participants or records.
Read the paper
Related studies
- Effectiveness of Bisphosphonates and Denosumab on Risk of Vertebral Fractures in Prostate Cancer Patients Under Androgen Deprivation Therapies: A Real-World Prospective Study
- Osteoporosis-related fractures after spinal cord injury: a retrospective study from Brazil
- Serum 25-hydroxyvitamin D, parathyroid hormone, and mortality in older men
- Lack of Association between Vitamin D Insufficiency and Cardiovascular or Fracture Risk: A UK Biobank Study
- Muscle strength and body composition are clinical indicators of osteoporosis
- Incidence of bone protection and associated fragility injuries in patients with proximal femur fractures
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.