Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2025
A randomised Phase 3 study comparing the efficacy and safety of proposed denosumab biosimilar RGB-14-P and reference denosumab in women with postmenopausal osteoporosis.
Trial report in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05087030 (A Randomised, Double Blind, Multicentre Phase III Study to Assess the Efficacy and Safety of RGB-14-P Compared to Prolia® in Women With Postmenopausal Osteoporosis), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomised, Double Blind, Multicentre Phase III Study to Assess the Efficacy and Safety of RGB-14-P Compared to Prolia® in Women With Postmenopausal Osteoporosis
Who cites it
2 citing papers in PubMed.
- Phase 3 study comparing the efficacy and safety of proposed biosimilar RGB-14-P with denosumab in postmenopausal women with osteoporosis: results from the transition (switch) phase.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026Trial
- A Randomized Phase 1 Study Comparing the PK, PD, Safety, and Immunogenicity of Proposed Biosimilar RGB-14-X and Denosumab in Healthy Adult Males.Clinical and translational science · 2026Trial
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
• In women with postmenopausal osteoporosis, proposed denosumab biosimilar RGB-14-P demonstrated equivalent efficacy and pharmacodynamics, and similar immunogenicity and safety to reference denosumab. • RGB-14-P comprehensively replicates the therapeutic benefit of denosumab in a clinical setting. • Denosumab biosimilars, such as RGB-14, have potential to provide lower-cost alternatives to denosumab with comparable efficacy and safety. PURPOSE: To demonstrate the equivalence of the proposed denosumab biosimilar RGB-14-P and the reference denosumab (hereafter denosumab) in women with postmenopausal osteoporosis.
methodsIn this multicentre, double-blind, Phase 3 study (EudraCT 2020-006017-38; NCT05087030), participants were randomised 1:1 to subcutaneous RGB-14-P or denosumab 60 mg every 6 months, on Day 1 and Week 26, with follow-up to Week 52. Primary endpoints were percentage change from baseline (%CfB) in lumbar spine bone mineral density (BMD) at Week 52 and area under the effective curve (AUEC) of %CfB serum C-terminal telopeptide of type 1 collagen (CTX) to Week 26. Secondary endpoints included %CfB in total hip and femoral neck BMD, vertebral and non-vertebral fragility fractures, immunogenicity, and safety to Week 52.
resultsOverall, 473 participants were randomised and received study drug (RGB-14-P, n = 242; denosumab, n = 231). Both primary endpoints demonstrated equivalence of RGB-14-P and denosumab. Adjusted mean (95% CI) %CfB in lumbar spine BMD at Week 52 was 4.89 (3.55, 6.24) for RGB-14-P and 4.55 (3.22, 5.87) for denosumab (estimated difference, 0.34; 95% CI, - 0.40, 1.09). Geometric mean ratio in AUEC of %CfB in CTX concentration was 1.01 (95% CI, 0.98, 1.05; P = 0.494). There were no statistical differences in %CfB in total hip and femoral neck BMD. Incidence of vertebral or non-vertebral fragility fractures was comparable between treatments. Anti-drug antibody incidence was < 1% in both arms. Safety was comparable between groups.
conclusionIn women with postmenopausal osteoporosis, RGB-14-P demonstrated equivalent efficacy and pharmacodynamics, and similar immunogenicity and safety to denosumab.
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