Effectiveness of oral bisphosphonates for primary prevention of osteoporotic fractures
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.
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.
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.
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.
KeywordsOsteoporosis Fracture prevention Bisphosphonates Nested case-control Databases
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.
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