Evidence map›Paper›PMID 40993439›Full record

SynthesisZeitschrift fur Rheumatologie2026

Comparative efficacy and safety of denosumab biosimilar and originator in postmenopausal osteoporosis: a meta-analysis of randomized controlled trials.

Young Ho Lee, Gwan Gyu Song

Abstract readMeta-AnalysisComparative StudyReview
PubMed Publisher
In one paragraph

Synthesis in Zeitschrift fur Rheumatologie, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Young Ho LeeDepartment of Rheumatology, Korea University Anam Hospital, Korea University College of Medicine, 73, Goryeodae-ro, 02841, Seongbuk-gu, Seoul, Korea (Republic of). lyhcgh@korea.ac.kr.ORCID http://orcid.org/0000-0003-4213-1909
Gwan Gyu SongDepartment of Rheumatology, Korea University Anam Hospital, Korea University College of Medicine, 73, Goryeodae-ro, 02841, Seongbuk-gu, Seoul, Korea (Republic of).

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe study aimed to assess whether a denosumab biosimilar is as effective and safe as the original denosumab for treating postmenopausal osteoporosis.

methodsA comprehensive search of MEDLINE, Embase, and the Cochrane databases identified six randomized controlled trials (RCTs) relevant to this study. The meta-analysis focused on evaluating percentage changes in bone mineral density (BMD) at the lumbar spine, femoral neck, and total hip, alongside monitoring adverse events (AEs), serious adverse events (SAEs), and infections.

resultsThe analysis encompassed 1784 patients, with 978 and 816 receiving biosimilar and originator therapy, respectively. Regarding standardized mean differences (SMDs) for BMD changes, a lumbar spine SMD of -0.048 (95% confidence interval [CI]: -0.142 to 0.046; P = 0.317), femoral neck SMD of 0.089 (95% CI: -0.068 to 0.247; P = 0.266), and total hip SMD of 0.029 (95% CI: -0.153 to 0.212; P = 0.755) were found, showing no significant differences between the two treatments. Safety profiles were also comparable, with odds ratios (ORs) of 1.168 (95% CI: 0.795-1.716; P = 0.428) for AEs, 1.120 (95% CI: 0.644-1.946; P = 0.689) for SAEs, and 1.576 (95% CI: 0.657-3.780; P = 0.308) for infections.

conclusionThe denosumab biosimilars demonstrated efficacy and safety profiles comparable to the originator in the treatment of postmenopausal osteoporosis.

Indexed as

Biosimilar PharmaceuticalsDenosumabOsteoporosis, PostmenopausalAgedBone DensityBone Density Conservation AgentsFemaleHumansMiddle AgedPrevalenceRandomized Controlled Trials as TopicRisk FactorsTreatment OutcomeBiosimilar PharmaceuticalsBone Density Conservation AgentsDenosumabBiological productsBone densityDenosumabMeta-analysisOsteoporosis

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.