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Effectiveness of oral bisphosphonates for primary prevention of osteoporotic fractures

Evidence from the AIFA-BEST observational study

  • Pharmacoepidemiology and Prescription
  • Published:
European Journal of Clinical Pharmacology Aims and scope Submit manuscript

Abstract

Purpose

Osteoporosis is a chronic disease of the bone, whose incidence increases progressively with aging. The main consequences of osteoporosis are fragility fractures, which have considerable medical, social, and economic implications. Adequate treatment of osteoporosis must be considered as a compelling public health intervention. Bisphosphonates (BPs) represent the most significant advance in this field in the past decade, and they are widely used in the treatment of osteoporosis. However, evidence for their effectiveness is limited to secondary prevention, whereas their effect in primary prevention is uncertain and needs further investigation.

Methods

Using administrative data collected in the “Biphosphonates Efficacy-Safety Tradeoff” (BEST) study, a nested case-control study was conducted by including 56,058 participants, aged 55 years who were started on oral BPs from 2003 to 2005. Cases were the 1,710 participants who were hospitalized for osteoporotic fractures until 2007. Up to 20 controls were randomly selected for each case. Conditional logistic regression model was used to estimate odds ratio of fracture associated with categories of treatment duration.

Results

Compared with participants assuming BPs for less than 1 year, those who remained on therapy for at least 2 years had a 21 % (95 % confidence interval (CI) 7 to 33 %) fracture risk reduction.

Conclusion

This study provides evidence that BPs, dispensed for primary prevention of osteoporotic fractures, are associated with a reduced risk of osteoporotic fractures after at least 2 years of treatment.

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Acknowledgments

This study was almost entirely funded by a research grant from the AIFA—the Italian Medicines Agency—(AIFA grant FARM06R9YY), Rome, Italy. Data analyses were performed at the Unit of Biostatistics and Epidemiology, Department of Statistics, University of Milano-Bicocca, with grants from the Italian Minister for University and Research (’Fondo d’Ateneo per la Ricerca’ portion, year 2010). The authors thank Mrs. Ann Georgina Rhodes for editorial assistance. Author’s roles: study design: GM and GC. Data collection: LS, FL, AlV, DG, RG, AnV, TS. Data analysis: AG, AZ. Data interpretation: AG, AZ, MDB, and GC. Drafting manuscript: AG, AZ, MDB, and GC. Revising manuscript content: AG, MDB and GC. Approving final version of manuscript: AG, MDB, AZ, LS, GDV, FL, FC, APC, AV, DG, RG, AV, TS, GM, and GC. AG, MDB and GC take responsibility for the integrity of the data analysis.

Conflict of interest

All authors declare that they have no conflict of interest.

Author information

Authors and Affiliations

  1. Unit of Biostatistics and Epidemiology, Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy

    Arianna Ghirardi, Antonella Zambon, Lorenza Scotti & Giovanni Corrao

  2. Research Unit of Medicine of Aging, Department of Experimental and Clinical Medicine, University of Florence—Azienda Ospedaliero Universitaria Careggi, Florence, Italy

    Mauro Di Bari

  3. Department of Informatics, Systems and Communications, University of Milano-Bicocca, Milan, Italy

    Gianluca Della Vedova

  4. Regional Agency for Healthcare Services of Tuscany, Florence, Italy

    Francesco Lapi, Francesco Cipriani & Giampiero Mazzaglia

  5. Department of Clinical and Experimental Medicine and Pharmacology, University of Messina, Messina, Italy

    Achille P. Caputi

  6. Regional Centre for Drug Evaluation and Information (CREVIF), Department of Pharmacology, University of Bologna, Bologna, Italy

    Alberto Vaccheri

  7. Department of Public Health and Microbiology, University of Turin, Turin, Italy

    Dario Gregori

  8. Center of Epidemiology, Biostatistics, and Medical Information Technology, Polytechnic University of Marche, Ancona, Italy

    Rosaria Gesuita

  9. Department of Public Health and Infectious Diseases, University “La Sapienza”, Rome, Italy

    Annarita Vestri

  10. Department of Medicine and Aging, University “G. d’Annunzio”, Chieti-Pescara, Italy

    Tommaso Staniscia

Authors
  1. Arianna Ghirardi
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  2. Mauro Di Bari
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  3. Antonella Zambon
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  4. Lorenza Scotti
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  5. Gianluca Della Vedova
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  6. Francesco Lapi
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  7. Francesco Cipriani
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  8. Achille P. Caputi
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  9. Alberto Vaccheri
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  10. Dario Gregori
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  11. Rosaria Gesuita
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  12. Annarita Vestri
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  13. Tommaso Staniscia
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  14. Giampiero Mazzaglia
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  15. Giovanni Corrao
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Consortia

This study is on behalf of the BEST investigators

Corresponding author

Correspondence to Mauro Di Bari.

Additional information

Best investigators

Mazzaglia G (main investigator): Regional Agency for Healthcare Services of Tuscany, Italy

Cipriani F (Head Unit), Lapi F, Sessa E: Regional Agency for Healthcare Services of Tuscany, Italy

Caputi AP (Head Unit), Arcoraci V: Department of Medicine and Pharmacology, University of Messina, Messina, Italy

Corrao G (Head Unit), Ghirardi A, Scotti L, Parodi A, Zambon A: Department of Statistics and Quantitative Methods, Unit of Biostatistics, Epidemiology and Public Health, University of Milano-Bicocca, Milan, Italy

Montanaro N (Head Unit), Piccinni C, Suzzi C, Puccini A, Vaccheri A: Regional Centre for Drug Evaluation and Information (CREVIF), Department of Pharmacology, University of Bologna, Bologna, Italy.

Sturkenboom M (Head Unit): Departments of Epidemiology & Biostatistics and Medical Informatics, Pharmacoepidemiology Unit, Erasmus University Medical Center, The Netherlands

Geppetti P (Head Unit), Sati L, Di Bari M: Center of Pharmacoutilization, Pharmacoepidemiology, Pharmacovigilance and Pharmacoeconomics, University of Florence, Florence, Italy

Gregori D (Head Unit), Forlan F: Department of Public Health and Microbiology, University of Turin, Turin, Italy

Carle F (Head Unit), Gesuita R: Center of Epidemiology, Biostatistics, and Medical Information Technology, Polytechnic University of Marche, Ancona, Italy. Provided data from Marche

Staniscia T (Head Unit), Menna A: Regional Agency of Healthcare services of Abruzzo, L’Aquila, Italy

Vestri A (Head Unit): Department of Public Health and Infectious Diseases, University “La Sapienza”, Rome, Italy

Valenti M (Head Unit): Department of Medicine and Public Health, University of L’Aquila, L’Aquila, Italy

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Supplemental Figure S1

Study flow diagram. AIFA-BEST project, Italy, 2003-2007 Footnote: BPs: Bisphosphonates (PDF 11 kb)

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Ghirardi, A., Di Bari, M., Zambon, A. et al. Effectiveness of oral bisphosphonates for primary prevention of osteoporotic fractures. Eur J Clin Pharmacol 70, 1129–1137 (2014). https://doi.org/10.1007/s00228-014-1708-8

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  • DOI: https://doi.org/10.1007/s00228-014-1708-8

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