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To the Editor: In the conclusions of the report on the Fracture Intervention Trial (FIT) Long-term Extension (FLEX), Dr Black and colleagues¹ state that "the results confirm the safety of alendronate for up to 10 years including no increased fracture risk with long-term alendronate use."¹ However, we do not believe that this study design warrants this conclusion. There is no group that received only placebo; those patients included in the "placebo" group had previously received alendronate for a mean of 5 years. Therefore, long-term alendronate safety cannot be determined from this study and requires a different trial.

In addition, patients who had taken alendronate, either 5 mg/d or 10 mg/d, in the FIT study were included in the same group for the FLEX study. It would be interesting to know the incidence of fractures in these 2 populations separately and whether there is any dose-related effect.

Finally, statistically significant higher . . . [Full Text of this Article]

Juan Erviti, PharmD, PhD
jervitil@cfnavarra.es

Javier Gorricho, PharmD
Drug Prescribing Service
Servicio Navarro de Salud
Pamplona, Spain

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Effects of Continuing or Stopping Alendronate After 5 Years of Treatment: The Fracture Intervention Trial Long-term Extension (FLEX): A Randomized Trial
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