Evidence map›Paper›PMID 39245627›Full record

ArticleBritish journal of clinical pharmacology2025

Incidence of new fractures in older patients with osteoporosis receiving biosimilar teriparatide or reference products: A retrospective cohort study.

So Sato, Yusuke Sasabuchi, Akira Okada, Hideo Yasunaga

Abstract readComparative Study
In one paragraph

Article in British journal of clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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

2 citing papers in PubMed.

  1. Article
  2. Article
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

4 authors.

So SatoDepartment of Clinical Epidemiology and Health Economics, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.ORCID https://orcid.org/0000-0003-1265-6835
Yusuke SasabuchiDepartment of Real-world Evidence, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Akira OkadaDepartment of Prevention of Diabetes and Lifestyle-Related Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Hideo YasunagaDepartment of Clinical Epidemiology and Health Economics, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.

Funding

Ministry of Health, Labour and Welfare 23AA2003
6 · The paper itself

Abstract

aimsBiosimilar products have clinical characteristics similar to those of brand-name products and can reduce medical costs. However, the use of biosimilar products for osteoporosis treatments remains limited due to concerns regarding its safety and efficacy. We aimed to clarify the effectiveness and safety of the biosimilar teriparatide compared with those of the reference product using the incidence of new fractures and osteosarcoma as outcomes in osteoporosis patients.

methodsThis study used the DeSC database, which contains medical claims data for various insurers in Japan. We included patients with osteoporosis aged ≥65 years who newly received either biosimilar teriparatide or the reference products between April 2019 and November 2022. Competing risk analyses were performed with adjustments for patient characteristics. The primary and secondary outcomes were the occurrence of new fractures and osteosarcoma, respectively.

resultsAmong 45 861 included patients, 3613 and 42 248 were in the biosimilar and reference product groups, respectively. The median follow-up duration was 439 days. New fractures occurred in 6.7% of patients. Cumulative incidence function curves showed similar risks of new fractures over time in both groups. The cause-specific hazard ratio for new fractures was 0.95 (95% confidence interval: 0.82-1.11) for the biosimilar group compared with that of the reference product group. The incidence of osteosarcoma did not differ significantly between the groups (P = .559).

conclusionsThe biosimilar teriparatide showed effectiveness and safety comparable with those of the reference products in treating osteoporosis patients. Our results suggest that clinicians need not hesitate to prescribe biosimilar teriparatide for osteoporosis patients.

Indexed as

Biosimilar PharmaceuticalsBone Density Conservation AgentsOsteoporosisTeriparatideAgedAged, 80 and overDatabases, FactualFemaleFractures, BoneHumansIncidenceJapanMaleOsteoporotic FracturesOsteosarcomaRetrospective StudiesBiosimilar PharmaceuticalsBone Density Conservation AgentsTeriparatidebiosimilar teriparatidefracturesosteoporosisreference products

Identifiers

PMID39245627
PMCPMC11671314

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Registered trials

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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.