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Retrospective evaluation of persistence in osteoporosis therapy with oral bisphosphonates in Italy: the TOBI study

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Abstract

Summary

The patients’ persistence with osteoporosis treatments is low. This retrospective, multicenter survey showed that almost 30% of osteoporotic patients discontinued the treatment within the first 6 months and that those taking drinkable bisphosphonates were less likely to interrupt the therapy; instead, the use of generic bisphosphonates was associated to a more precocious interruption.

Purpose

Low persistence with osteoporosis medications is associated with higher fracture risk. This study aimed to assess the persistence to treatment with oral bisphosphonates among Italian osteoporotic patients under treatment for at least 6 months and to evaluate whether the different oral formulations of bisphosphonates may influence the interruption of the therapy.

Methods

723 consecutive osteoporotic patients, aged 50 years or over, referred as outpatients for a follow-up visit after receiving a prescription of an oral bisphosphonate for the first time for at least 6 months were enrolled in this retrospective, multicenter survey carried out under conditions of usual clinical practice. All the patients enrolled were submitted to a standardized interview.

Results

191 patients turned out to have discontinued treatment (28.7%), the more common causes for interruption being the adverse events (43.9%), fear of adverse events (23.3%) and perceived absence of efficacy of the treatment (15.8%). The osteoporotic patients taking drinkable bisphosphonate or on treatment with aromatase inhibitors or under the age of 70 years were less likely to interrupt the treatment. However, these associations were no longer significant when the pharmaceutical formulation (generic vs branded) was included into the multivariate logistic regression model.

Conclusion

This study suggests that the new drinkable formulations of bisphosphonates could be an interesting option able to reduce upper GI adverse events, thus increasing persistence; whereas the generic formulations of bisphosphonates were associated to a premature discontinuation.

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Acknowledgements

We would like to thank Professor G. Cevenini for his advice in the revision of the statistical analysis.

Funding

No funding was received for this research.

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Authors and Affiliations

  1. Department of Medicine, Surgery and Neuroscience, University of Siena, Policlinico Le Scotte, Viale Bracci 2, 53100, Siena, Italy

    Stefano Gonnelli, Carla Caffarelli & Ranuccio Nuti

  2. Department of Surgical and Oncology Sciences, University of Palermo, Palermo, Italy

    Giulia Letizia Mauro

  3. Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy

    Ombretta Di Munno

  4. Rheumatology Unit, S.Orsola-Malpighi Teaching Hospital, Bologna, Italy

    Nazzarena Malavolta

  5. Department of Movement, Human and Health Sciences, Section of Health Sciences, University of Rome, Foro Italico, Rome, Italy

    Silvia Migliaccio

Authors
  1. Stefano Gonnelli
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  2. Carla Caffarelli
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  3. Giulia Letizia Mauro
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  4. Ombretta Di Munno
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  5. Nazzarena Malavolta
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  6. Silvia Migliaccio
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  7. Ranuccio Nuti
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Corresponding author

Correspondence to Stefano Gonnelli.

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On behalf of all authors, I declare no conflict of interest.

Ethical approval

All procedures performed in this study involving human participants were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration. Procedures performed in this study did not involve animals.

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

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Gonnelli, S., Caffarelli, C., Letizia Mauro, G. et al. Retrospective evaluation of persistence in osteoporosis therapy with oral bisphosphonates in Italy: the TOBI study. Aging Clin Exp Res 31, 1541–1547 (2019). https://doi.org/10.1007/s40520-019-01205-7

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  • DOI: https://doi.org/10.1007/s40520-019-01205-7

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