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 values of bone mineral density (BMD) were found in the alendronate group at the hip, femoral neck, trochanter, lumbar spine, forearm, and total body. However, no difference in fracture incidence was observed in spite of a high (19%) incidence of nonvertebral fractures. This indicates that BMD is a surrogate end point that may not be reliable to assess a decrease in fracture incidence.
Financial Disclosures: None reported.
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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