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European Journal of Clinical Pharmacology

, Volume 70, Issue 9, pp 1129–1137 | Cite as

Effectiveness of oral bisphosphonates for primary prevention of osteoporotic fractures

Evidence from the AIFA-BEST observational study
  • Arianna Ghirardi
  • Mauro Di BariEmail author
  • Antonella Zambon
  • Lorenza Scotti
  • Gianluca Della Vedova
  • Francesco Lapi
  • Francesco Cipriani
  • Achille P. Caputi
  • Alberto Vaccheri
  • Dario Gregori
  • Rosaria Gesuita
  • Annarita Vestri
  • Tommaso Staniscia
  • Giampiero Mazzaglia
  • Giovanni Corrao
  • This study is on behalf of the BEST investigators
Pharmacoepidemiology and Prescription

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.

Keywords

Osteoporosis Fracture prevention Bisphosphonates Nested case-control Databases 

Notes

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.

Supplementary material

228_2014_1708_MOESM1_ESM.doc (42 kb)
ESM 1 (DOC 42 kb)
228_2014_1708_MOESM2_ESM.pdf (12 kb)
Supplemental Figure S1 Study flow diagram. AIFA-BEST project, Italy, 2003-2007 Footnote: BPs: Bisphosphonates (PDF 11 kb)

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Copyright information

© Springer-Verlag Berlin Heidelberg 2014

Authors and Affiliations

  • Arianna Ghirardi
    • 1
  • Mauro Di Bari
    • 2
    Email author
  • Antonella Zambon
    • 1
  • Lorenza Scotti
    • 1
  • Gianluca Della Vedova
    • 3
  • Francesco Lapi
    • 4
  • Francesco Cipriani
    • 4
  • Achille P. Caputi
    • 5
  • Alberto Vaccheri
    • 6
  • Dario Gregori
    • 7
  • Rosaria Gesuita
    • 8
  • Annarita Vestri
    • 9
  • Tommaso Staniscia
    • 10
  • Giampiero Mazzaglia
    • 4
  • Giovanni Corrao
    • 1
  • This study is on behalf of the BEST investigators
  1. 1.Unit of Biostatistics and Epidemiology, Department of Statistics and Quantitative MethodsUniversity of Milano-BicoccaMilanItaly
  2. 2.Research Unit of Medicine of Aging, Department of Experimental and Clinical MedicineUniversity of Florence—Azienda Ospedaliero Universitaria CareggiFlorenceItaly
  3. 3.Department of Informatics, Systems and CommunicationsUniversity of Milano-BicoccaMilanItaly
  4. 4.Regional Agency for Healthcare Services of TuscanyFlorenceItaly
  5. 5.Department of Clinical and Experimental Medicine and PharmacologyUniversity of MessinaMessinaItaly
  6. 6.Regional Centre for Drug Evaluation and Information (CREVIF), Department of PharmacologyUniversity of BolognaBolognaItaly
  7. 7.Department of Public Health and MicrobiologyUniversity of TurinTurinItaly
  8. 8.Center of Epidemiology, Biostatistics, and Medical Information TechnologyPolytechnic University of MarcheAnconaItaly
  9. 9.Department of Public Health and Infectious DiseasesUniversity “La Sapienza”RomeItaly
  10. 10.Department of Medicine and AgingUniversity “G. d’Annunzio”Chieti-PescaraItaly

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