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J Clin Endocrinol Metab. 2010 Dec;95(12):5258-65. doi: 10.1210/jc.2010-1571. Epub 2010 Sep 15.

Cumulative alendronate dose and the long-term absolute risk of subtrochanteric and diaphyseal femur fractures: a register-based national cohort analysis.

Author information

1
Odense Patient Data Exploratory Network, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark. b.abrahamsen@physician.dk

Abstract

CONTEXT:

Bisphosphonates are the mainstay of anti-osteoporotic treatment and are commonly used for a longer duration than in the placebo-controlled trials. A link to development of atypical subtrochanteric or diaphyseal fragility fractures of the femur has been proposed, and these fractures are currently the subject of a U.S. Food and Drug Administration review.

OBJECTIVE:

Our objective was to examine the risk of subtrochanteric/diaphyseal femur fractures in long term users of alendronate.

DESIGN:

We conducted an age- and gender-matched cohort study using national healthcare data.

PATIENTS:

Patients were alendronate users, without previous hip fracture, who began treatment between January 1, 1996, and December 31, 2005 (n=39,567) and untreated controls, (n=158,268).

MAIN OUTCOME MEASURES:

Subtrochanteric or diaphyseal femur fractures were evaluated.

RESULTS:

Subtrochanteric and diaphyseal fractures occurred at a rate of 13 per 10,000 patient-years in untreated women and 31 per 10,000 patient-years in women receiving alendronate [adjusted hazard ratio (HR)=1.88; 95% confidence interval (CI)=1.62-2.17]. Rates for men were six and 31 per 10,000 patient-years, respectively (HR=3.98; 95% CI=2.62-6.05). The HR for hip fracture was 1.37 (95% CI=1.30-1.46)) in women and 2.47 (95% CI=2.07-2.95) in men. Risks of subtrochanteric/diaphyseal fracture were similar in patients who had received 9 yr of treatment (highest quartile) and patients who had stopped therapy after the equivalent of 3 months of treatment (lowest quartile).

CONCLUSIONS:

Alendronate-treated patients are at higher risk of hip and subtrochanteric/diaphyseal fracture than matched control subjects. However, large cumulative doses of alendronate were not associated with a greater absolute risk of subtrochanteric/diaphyseal fractures than small cumulative doses, suggesting that these fractures could be due to osteoporosis rather than to alendronate.

PMID:
20843943
PMCID:
PMC2999980
DOI:
10.1210/jc.2010-1571
[Indexed for MEDLINE]
Free PMC Article
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