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To the Editor: We believe that due caution must be taken when interpreting the results of the Fracture Intervention Trial II (FIT-II),¹ since the conclusion appears to be based on post hoc subgroup analysis. Instead, the efficacy based on the intent-to-treat analysis should be considered, ie, the effect of alendronate achieved according to analysis based on the study groups to which they were originally randomized, even though the classification of low bone mineral density (BMD) was changed during the study, resulting in one third of the study population actually having higher BMD than intended.

The results of the intent-to-treat analysis show that the efficacy of alendronate is quite disappointing, showing no significant effect on major end points other than for the groups "other clinical," comprising fractures other than in the hip, wrist, or spine with a 4.2-year number needed to treat (NNT) of 50 (95% confidence interval [CI], 27-322), and . . . [Full Text of this Article]