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Two-year risedronate treatment for osteoporosis in patients with esophageal varices: a non-randomized clinical trial

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Abstract

Background

Bisphosphonates are the mainstay of osteoporosis treatment, but their use for patients with esophageal varices has been avoided due to the risk of esophagitis, which may cause variceal bleeding. Since most clinical trials assessing osteoporosis treatment last 2–3 years, this study aimed to evaluate a 2-year risedronate treatment for patients with esophageal varices and liver cirrhosis.

Methods

The study received Institutional Review Board approval, and the sample was divided into two groups according to bone mineral density (BMD). Cirrhosis severity and endoscopic findings at baseline were similar between the groups. The intervention group had 51 patients with osteoporosis, who received oral risedronate 35 mg weekly plus calcium and vitamin D supplements. The control group had 51 patients with osteopenia, receiving only the supplements. Scheduled esophagogastroduodenoscopies and BMD measurements were carried out.

Results

The adjusted esophagitis risk was higher in the intervention group; however, none of the subjects had digestive bleeding. Lumbar spine BMD increased in the intervention group (− 3.06 ± 0.71 to − 2.33 ± 0.90; p < 0.001) and in the control group (− 1.38 ± 0.77 to − 1.10 ± 1.05; p = 0.012). Femoral neck BMD did not change in the intervention group (− 1.64 ± 0.91 to − 1.71 ± 0.95; p = 0.220), but tended to decrease in the control group (− 1.00 ± 0.74 to − 1.09 ± 0.82; p = 0.053).

Conclusion

Oral risedronate was effective and did not cause gastrointestinal bleeding in cirrhotic patients with esophageal varices under endoscopic surveillance.

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Data availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Abbreviations

BMD:

Bone mineral density

DXA:

Dual-energy X-ray absorptiometry

EVBL:

Endoscopic variceal band ligation

PHG:

Portal hypertensive gastropathy

UGIB:

Upper gastrointestinal bleeding

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Acknowledgements

The authors would like to acknowledge the grant support received from the São Paulo Research Foundation (FAPESP) and from Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq).

Funding

This study was funded by São Paulo Research Foundation (FAPESP) through Grant Nos. 2016/07117-9 and 2014/22572-9.

Author information

Author notes

  1. Lívia Alves Amaral Santos and Talles Bazeia Lima have contributed equally.

Authors and Affiliations

  1. Internal Medicine Department, Botucatu Medical School, Gastroenterology Division-São Paulo State University (UNESP), Rubião Júnior s/n, Botucatu, SP, CEP 18618-687, Brazil

    Lívia Alves Amaral Santos, Talles Bazeia Lima & Fernando Gomes Romeiro

  2. Public Health Department, Botucatu Medical School, São Paulo State University (UNESP), Botucatu, Brazil

    Hélio Rubens de Carvalho Nunes

  3. General Hospital of Shenyang Military Command, Liaoning, Sheng, China

    **ngshun Qi

Authors
  1. Lívia Alves Amaral Santos
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  4. **ngshun Qi
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  5. Fernando Gomes Romeiro
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Contributions

Lívia Alves Amaral Santos, Talles Bazeia Lima and Fernando Gomes Romeiro designed the study, conducted the patients, collected the data and drafted the manuscript. Hélio Rubens de Carvalho Nunes performed the statistical analysis. **ngshun Qi and Fernando Gomes Romeiro reviewed and modified the manuscript until achieving the final version of the article, which was approved by all the authors.

Corresponding author

Correspondence to Fernando Gomes Romeiro.

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Conflict of interest

Lívia Alves Amaral Santos, Talles Bazeia Lima, Hélio Rubens de Carvalho Nunes, **ngshun Qi and Fernando Gomes Romeiro declare that they have no conflict of interest.

Ethics approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee (denoted “Comitê de Ética em Pesquisa” - protocol number 089211-2013) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Clinical trials registration

The project was registered in a publicly accessible primary International Clinical Trial Registry Platform (named REBEC clinical trials platform, available at http://www.ensaiosclinicos.gov.br), where the registration date and the trial registration number were 10/11/2015 and RBR-76pm35, respectively.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Santos, L.A.A., Lima, T.B., de Carvalho Nunes, H.R. et al. Two-year risedronate treatment for osteoporosis in patients with esophageal varices: a non-randomized clinical trial. Hepatol Int 16, 1458–1467 (2022). https://doi.org/10.1007/s12072-022-10366-z

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