The primary endpoint was the mean percentage change from baseline in total hip BMD at month 12. The secondary endpoints

were the mean percentage change in femoral neck and lumbar spine BMD at month 12 and the median percentage change from baseline in sCTX-1 at month 1. An exploratory endpoint was the median percentage change from baseline in sCTX-1 at month 6. Safety was assessed over the 12-month study through incidence of adverse events (AEs) and serious adverse events (SAEs) that were collected CP-868596 purchase throughout the study. The full analysis set included all randomized subjects and was used to analyze all BMD endpoints. The mean percentage change from baseline for each of the BMD skeletal sites at month 12 was analyzed using an analysis of covariance (ANCOVA) model including treatment and adjusting for study day of BMD assessment, selleck inhibitor treatment

by BMD-assessment-day interaction, baseline BMD value, DXA machine type, and baseline BMD value by DXA-machine-type interaction. Summary statistics for the results included least-squares means point estimates of the mean percentage change from baseline for each treatment group at month 12. The 95% two-sided confidence intervals (CIs) and associated p-values were provided for the treatment difference between the least-squares means at month 12 for denosumab and risedronate for each skeletal site. The pre-specified

primary analytical approach for BMD endpoints employed an imputation for missing baseline and post-baseline Histone demethylase BMD. For each anatomical site, missing baseline BMD values were imputed with the mean of all non-missing baseline BMD data from the same corresponding machine type (Hologic or Lunar). Missing post-baseline BMD values were imputed with the predicted values from the regression model based on baseline covariates of each individual subject. Other sensitivity analyses and an additional post-hoc analysis based on subjects with complete data were also performed. Since none of these analyses changed the overall conclusions of the findings, this manuscript will focus on findings from the pre-specified primary analysis. The primary ANCOVA analysis mentioned above was repeated controlling for pre-specified covariates (baseline age, prior alendronate treatment [duration, time since initiation, time since discontinuation, and branded or generic alendronate], previous osteoporotic fractures, and baseline sCTX-1), individually and simultaneously. Moreover, all BMD endpoints were analyzed by each covariate subgroup, and the treatment-by-subgroup interaction term was further assessed in the ANCOVA model. If the p-value of an interaction term was ≥ 0.05, the quantitative treatment-by-subgroup interaction was considered not significant.