Statistical Considerations. Statistical analysis will focus on longer term safety, fracture incidence, including vertebral fracture and BMD change following six months of standard-of-care osteoporosis treatment in subjects who have previously received 18 months of blinded treatment with BA058 Injection 80 µg/Placebo. The analyses will be performed based on the treatment arm they were randomized to in the BA058-05-003 study. The analyses performed on data collected at Month 12 and Month 24 will be descriptive in nature and will be summarized descriptively with number, percentage (for categorical variables), mean, standard deviation, median, minimum and maximum (for continuous variables). The analyses performed at six months will be used as a follow-up to the 18 month fracture endpoint for Study BA058-05-003. At this time-point, subjects will be analyzed based upon the randomization assignment in the BA058-05-003 study.
Appears in 2 contracts
Sources: Clinical Trial Services Agreement (Radius Health, Inc.), Clinical Trial Services Agreement (Radius Health, Inc.)