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UNLABELLED: In a cohort study of users of bisphosphonates, we evaluated the incidence of fragility fractures at all sites on the femur following for up to 8 years of therapy with alendronate or risedronate. We did not find evidence for a reversal of fracture protection with long-term use of bisphosphonates. INTRODUCTION: Few studies have acquired adequate data with prolonged follow-up on bisphosphonate users in the general population to evaluate their long-term effects on the risk of hip fractures including those in the subtrochanteric region. METHODS: This cohort study utilizes a large USA database (January 1, 2000 to June 30, 2009). We compared patients with higher versus lower degrees of compliance [medication possession ratio, MPR <1/3 (the reference), 1/3-<2/3, or ≥ 2/3]. Radiographic adjudication of fracture site and features were not performed. Hazard ratios (HR) for fracture were estimated using time-dependent Cox models. Restricted cubic splines (RCS) were used to plot HRs for fracture against duration of therapy. RESULTS: There were 3,655 incident cases of femoral fracture (764 subtrochanteric/shaft, 2,769 hip) identified during 917,741 person-years of follow-up (median  =  3 years) on 287,099 patients (267,374 were women) from the date when they initiated oral bisphosphonate therapy. The corresponding HRs (95% confidence interval, CI) for overall femoral fractures associated with each additional year of therapy were 0.93 (0.86-1.01) within 5 years, and 0.89 (0.77-1.03) beyond 5 years for risedronate and 0.86 (0.81-0.91) and 0.95 (0.84-1.07) for alendronate, respectively. The corresponding estimates for subtrochanteric/shaft fractures were 1.05 (0.87-1.26) and 0.89 (0.60-1.33) for risedronate and 0.99 (0.92-1.05) and 1.05 (0.92-1.20) for alendronate, respectively. The HRs (95% CI) for overall femoral fractures associated with each additional year of alendronate or risedronate therapy within 5 and beyond 5 years were not significantly different. CONCLUSION: Our study showed persistence of overall hip fracture protection with long-term use of alendronate or risedronate.

Original publication

DOI

10.1007/s00198-012-1952-7

Type

Journal article

Journal

Osteoporos int

Publication Date

12/2012

Volume

23

Pages

2873 - 2884

Keywords

Administration, Oral, Aged, Alendronate, Cohort Studies, Diphosphonates, Drug Administration Schedule, Etidronic Acid, Female, Femoral Fractures, Hip Fractures, Humans, Incidence, Male, Middle Aged, Osteoporosis, Osteoporotic Fractures, Risedronic Acid, United States