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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 for the group "1 or more vertebral fractures," for which the 4.2-year NNT is 64 (95% CI, 39-162).
Drawing a conclusion from a post hoc subgroup analysis is hazardous and should not be done. Although FIT-II initially was designed to examine the effect of alendronate on primary fracture prevention in women with low BMD (less than 2 SDs below the mean), the resulting subgroup analysis yielding a 4.2-year NNT of 15 (95% CI, 10-36) to prevent a "clinical fracture" in the lowest BMD tertile (less than 2.5 SDs below the mean) is not methodologically convincing, and we disagree that a conclusion should be drawn from this analysis. The results are more confusing when looking at those with higher BMD, since there seems to be a slight but nonsignificant increase in the absolute risk of clinical fractures. Finally, why were the patients grouped into tertiles and not quartiles or quintiles?
Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature
Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal
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