Evidence map›Paper›PMID 36602591›Full record

ArticleEuropean journal of clinical pharmacology2023

Testosterone treatment and the risk of osteonecrosis: a pharmacovigilance analysis in Vigibase.

Clémentine Vabre, Kyle Johnson, François Montastruc, Delphine Vezzosi, Oriana H Yu, Christel Renoux

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Article in European journal of clinical pharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 37% of its field
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, 2 citations in OpenAlex.

  1. Review
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

6 authors at 3 institutions in 2 countries.

Clémentine VabreDepartment of Medical and Clinical Pharmacology, Centre of Pharmaco Vigilance and Pharmacoepidemiology, Toulouse University Hospital, Faculty of Medicine, 37 Allées Jules Guesde, Toulouse, 31000, France.
Kyle JohnsonDepartment of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Québec, Canada.ORCID http://orcid.org/0000-0002-4366-2392
François MontastrucDepartment of Medical and Clinical Pharmacology, Centre of Pharmaco Vigilance and Pharmacoepidemiology, Toulouse University Hospital, Faculty of Medicine, 37 Allées Jules Guesde, Toulouse, 31000, France. francois.montastruc@univ-tlse3.fr.ORCID http://orcid.org/0000-0001-7056-8126
Delphine VezzosiDepartment of Endocrinology, Larrey Hospital, CardioMet Institute, University Hospital Centre of Toulouse, Toulouse, France.
Oriana H YuCenter for Clinical Epidemiology, Lady Davis Research Institute, Jewish General Hospital, McGill University, Montreal, Québec, Canada.
Christel RenouxDepartment of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Québec, Canada.ORCID http://orcid.org/0000-0002-4691-9579
Jewish General Hospital · CAUniversité Toulouse III - Paul Sabatier · FRHôpital Larrey · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeRecent reports have raised concerns about a potential risk of osteonecrosis associated with testosterone treatment (TT). The aim of this pharmacovigilance study was to assess the risk of reporting osteonecrosis associated with the use of TT compared with use of any other medication.

methodsWe performed a disproportionality analysis to investigate the risk of reporting osteonecrosis with TT using the WHO database VigiBase

resultsAmong men at least 18 years of age between January 1, 2000, and December 31, 2019, we identified 3479 reports of osteonecrosis, 84 of which were associated with TT use, out of a total of 4,667,754 adverse event reports. Reports of osteonecrosis in TT users occurred with both transdermal and injectable forms, and the mean age at report was 55.4 years. TT use was associated with a greater risk of reporting osteonecrosis compared to all other drugs (ROR, 5.13; 95% CI, 4.13-6.37) and compared with use of drugs for BPH (ROR, 3.00; 95% CI, 2.08-4.30). Half of the osteonecrosis reports associated with TT indicated concomitant use of corticosteroids.

conclusionTT was associated with a greater risk of reports of osteonecrosis compared to use of any other drug and use of drugs for BPH. This signal should be confirmed in complementary studies.

Indexed as

OsteonecrosisProstatic HyperplasiaAdverse Drug Reaction Reporting SystemsDatabases, FactualHumansMaleMiddle AgedPharmacovigilanceTestosteroneTestosteroneClinical pharmacologyHypogonadismOsteonecrosisTestosterone

Identifiers

PMID36602591
OpenAlexW4313545666

What OpenQuestion holds

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Read underepoch 390

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.