Fractures and BMD Analysis. All specified endpoints will be summarized by treatment group and study period using standard descriptive statistics (n, mean, SD, median, minimum, maximum, or n and %, as appropriate). The fracture incidence and BMD results from the additional six months of treatment with alendronate will be tabulated based on the treatment arm they were randomized to in the BA058-05-003 study, with additional tabular categories for results from the entire contiguous 24 months from the baseline of Study BA058-05-003, for subjects who eventually enter study BA058-05-005. These descriptive analyses will be conducted on all subjects with baseline and post-baseline data. The analysis performed at six months will be used a follow-up to the 18 month fracture endpoint for Study BA058-05-003. The data collected at Month 12 and Month 24 will be tabulated for each efficacy endpoint (vertebral fracture, non-vertebral fracture, and spine, femoral neck and forearm BMD). This information will be summarized according to original treatment assignment, osteoporosis medications taken between Month 6 and Month 24, and other patient characteristics.
Appears in 2 contracts
Sources: Clinical Trial Services Agreement (Radius Health, Inc.), Clinical Trial Services Agreement (Radius Health, Inc.)