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 analyzed based on the treatment arm they were randomized to in the BA058-05-003 study. These 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. Vertebral fractures based on radiologic assessments will also be analyzed at Month 24. Additional analyses for the other endpoints will also be performed cumulatively at Month 12, 18, and 24 (i.e., Visits 4, 5, and 6). Full details of these analyses will be provided in the Statistical Analysis Plan.
Appears in 2 contracts
Sources: Clinical Trial Services Agreement (Radius Health, Inc.), Clinical Trial Services Agreement (Radius Health, Inc.)