Evidence map›Paper›PMID 40665152›Full record

ArticleArchives of osteoporosis2025

Association between ramelteon use and risk of fragility fractures: A retrospective cohort study.

Hitoshi Tange, Yoshihisa Miyamoto, Yusuke Sasabuchi, Hideo Yasunaga

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Article in Archives of osteoporosis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

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0cells of the map it votes in
1citing papers in PubMed
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1 · What the graph read from it

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3 · Its place in the literature

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1 citing paper in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

4 authors.

Hitoshi TangeDepartment of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, 7-3-1, Hongo, Bunkyo-Ku, Tokyo, 1130033, Japan. tange-oit@umin.ac.jp.
Yoshihisa MiyamotoDepartment of Real-World Evidence, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Yusuke SasabuchiDepartment of Real-World Evidence, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Hideo YasunagaDepartment of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, 7-3-1, Hongo, Bunkyo-Ku, Tokyo, 1130033, Japan.

Funding

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

Abstract

The effect of melatonin receptor agonists on bone remains unclear. This retrospective cohort study provides the first evidence that the short- to mid-term use of ramelteon is not associated with the risk of fracture. Further research with longer follow-up is needed to clarify the effects of ramelteon on bone health.

backgroundRecent studies have suggested that melatonin may have the potential to treat osteoporosis. However, few studies have examined the effects of melatonin receptor agonists on bone health. This study aimed to evaluate the association between ramelteon use and the risk of fragility fractures.

methodsWe conducted a retrospective cohort study from April 2014 to November 2022 using the DeSC database, a large healthcare claims database in Japan, employing an active comparator and new-user design. Female participants aged ≥ 50 years were included in the study. Exposure was defined as the first dispensation of ramelteon or orexin receptor antagonists. The outcome was a composite of major fragility fractures, including hip, vertebral, wrist, proximal humeral, and ankle fractures. To adjust for potential confounders, we used overlap weighting analysis with propensity scores. Cox regression analyses were performed both before and after applying overlap weighting.

resultsA total of 106,511 individuals were identified, including 23,312 new ramelteon users and 83,199 new orexin receptor antagonist users. The overall fracture incidence was 9,429 per 100,000 person-years in the ramelteon group and 7,330 per 100,000 person-years in the orexin receptor antagonist group. The adjusted hazard ratio for overall fractures associated with ramelteon use was 1.07 (95% confidence interval: 0.99-1.17). The results were consistent across fracture types, age groups, and landmark analyses.

conclusionsIn a real-world setting, short- to mid-term ramelteon use was not associated with an increased risk of fractures. Future studies should consider longer follow-up periods to further investigate the effects of ramelteon on bone health.

Indexed as

IndenesOsteoporotic FracturesAgedAged, 80 and overFemaleHumansJapanMiddle AgedRetrospective StudiesRisk FactorsIndenesramelteonFractureMelatonin receptor agonistsPropensity scoreRamelteonReal-world data

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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.