2.9. Power Calculation and Statistical Analysis
L2-L4 lumbar spine region
SECONDARY
The sample size was calculated to detect a difference in the change from baseline to 48 weeks in BMD measured by DXA on the L2-L4 lumbar spine region between HE and placebo (primary outcome) with consideration of the findings from previous studies [Data were analyzed using SASThe primary outcome, and all other DXA parameters, were analyzed using an analysis of covariance (ANCOVA) including analysis group, baseline values, time since menopause at screening (months), and BMI at baseline (kg/mFor bone biomarkers, the changes from baseline in each parameter were analyzed at week 48 using a mixed model for repeated measures (MMRM), including the following covariates, in addition to analysis group and baseline value: time since menopause at screening and BMI at baseline. Comparisons within and between groups were studied. Regarding the other secondary and exploratory outcomes, depending on planned time points, an ANCOVA at week 48 including analysis group and baseline value or a MMRM including analysis group, visit, baseline values, and group*visit interaction was performed.For all analyses, normality distribution of the residuals was verified by Skewness and Kurtosis. If the adequacy of the model could not be validated, the parameter was derived using the log transformation of the values at each time point and was then modeled with the same model characteristics. If the adequacy of the new model was not able to be validated on the log transformation, a non-parametric analysis of covariance, based on ranks (rank ANCOVA) with the same covariates was performed for the comparison between groups and Wilcoxon signed-rank test for the comparison within group.Regarding safety, all analyses were performed on all participants who received at least one dose of study treatment according to the analysis groups. The incidence of AEs was assessed, and a description according to SOC and PT was tabulated. The number of patients with at least one TEAE was compared between analysis groups using a chi-squared test. Normal data were reported as means ± SD and non-normal data as median (Q1; Q3). All statistical tests were conducted two-sided with a significance level of 5%. No adjustment for multiplicity was considered.