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Statistical Analysis of Risedronate versus Placebo in Preventing Anastrozole

Patel Coleman

For women in stratum II who were randomly assigned to anastrozole, the primary objective of this analysis was to compare the effect of risedronate versus placebo on the change in BMD at the lumbar spine and total hip between baseline and 5 years. At 12 and 60 months of follow-up, secondary objectives included comparing the effects of randomized treatment on baseline PINP measurements. The percentage changes in mean BMD at the lumbar spine and total hip between baseline and 5 years, along with the corresponding 95% confidence intervals, are shown in all of the results. Using paired t-tests for normal distribution, changes in BMD and differences between treatment groups were evaluated. The relationship between BMD and PINP values was examined using Pearson's correlation coefficient analysis. Risk ratios and adverse events were compared. P-values were based on normal approximation and were two-sided. All confidence intervals were 95 percent. STATA version 13.1 (College Station, Texas, USA) was used for analyses. This analysis included 258 women in stratum II who had baseline and up to five-year follow-up BMD measurements. depicts women's baseline characteristics for this analysis. Over the course of the five years of followup, only 26 women (or 4% of the stratum II population) were found to not have fully adhered to risedronate.