Trial reportArthritis research & therapy2022
Efficacy and safety of the biosimilar denosumab candidate (Arylia) compared to the reference product (Prolia®) in postmenopausal osteoporosis: a phase III, randomized, two-armed, double-blind, parallel, active-controlled, and noninferiority clinical trial.
Trial report in Arthritis research & therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03293108 (A Phase III, Randomized, Two-armed, Parallel, Double-blind, Active-controlled, Non-inferiority Clinical Trial to Determine the Non-inferior Therapeutic Efficacy and Safety Between Arylia), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.
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 Phase III, Randomized, Two-armed, Parallel, Double-blind, Active-controlled, Non-inferiority Clinical Trial to Determine the Non-inferior Therapeutic Efficacy and Safety Between Arylia (60 mg, Denosumab, Produced by AryoGen Pharmed) Compared With Prolia® (60 mg, Denosumab, the Reference Drug, Produced by Amgen Company) in the Improvement of Bone Mineral Densitometry (BMD) Among Osteoporotic Postmenopausal Women
Who cites it
6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 11 citations in OpenAlex.
- Comparative efficacy and safety of denosumab biosimilar and originator in postmenopausal osteoporosis: a meta-analysis of randomized controlled trials.Zeitschrift fur Rheumatologie · 2026Pooled it
- Efficacy and safety of denosumab biosimilars in the treatment of postmenopausal osteoporosis: A systematic review of randomized clinical trials.Clinical and experimental medicine · 2026Pooled it
- Trial
- Comparison of pharmacokinetics, pharmacodynamics, safety, and immunogenicity of a candidate biosimilar INTP23.1 with EU and US‑approved denosumab reference products in healthy adult men.Naunyn-Schmiedeberg's archives of pharmacology · 2026Trial
- Trial
- Efficacy and safety of candidate biosimilar CT-P41 versus reference denosumab: a double-blind, randomized, active-controlled, Phase 3 trial in postmenopausal women with osteoporosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2024Trial
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors at 12 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND/
objectiveOsteoporosis is a global health concern with an increasing prevalence worldwide. Denosumab is an antiresoptive agent that has been demonstrated to be effective and safe in osteoporotic patients. This study aimed to compare the efficacy and safety of the biosimilar denosumab candidate (Arylia) to the originator product (Prolia®) in postmenopausal osteoporotic patients.
methodsIn this randomized, double-blind, active-controlled, noninferiority trial, postmenopausal osteoporotic patients received 60 mg of subcutaneous Arylia or Prolia® at months 0, 6, and 12 and were followed up for 18 months. The primary endpoint was the noninferiority of the biosimilar product to the reference product in the percentage change of bone mineral density (BMD) in 18 months at the lumbar spine (L
resultsA total of 190 patients were randomized to receive either biosimilar (n = 95) or reference (n = 95) denosumab. In the per-protocol (PP) analysis, the lower limits of the 95% two-sided confidence intervals of the difference between Arylia and Prolia® in increasing BMD were greater than the predetermined noninferiority margin of - 1.78 at the lumbar spine, total hip, and femoral neck sites (mean differences [95% CIs] of 0.39 [- 1.34 to 2.11], 0.04 [- 1.61 to 1.69], and 0.41 [- 1.58 to 2.40], respectively). The two products were also comparable in terms of safety, new vertebral fractures, and trend of BTMs.
conclusionThe efficacy of the biosimilar denosumab was shown to be noninferior to that of the reference denosumab, with a comparable safety profile at 18 months.
trial registrationClinicalTrials.gov, NCT03293108 ; Registration date: 2017-09-19.
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