Statistical Considerations. Statistical analysis will focus on safety, fracture incidence, including vertebral fracture and BMD change following six months of alendronate treatment in subjects who have previously received 18 months of blinded treatment with Abaloparatide-SC/Placebo. Additional analyses will also be cumulatively at Month 12, 18, and 24 (i.e., Visit 4, 5, and 6). Full details of these analyses will be provided in the Statistical Analysis Plan. The efficacy and safety analyses performed at six months will be used as a follow-up to the 18 month fracture endpoint for Study BA058-05-003. Subjects will be analyzed based upon the randomization assignment in the BA058-05-003 study.
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Sources: Clinical Trial Services Agreement (Radius Health, Inc.), Clinical Trial Services Agreement (Radius Health, Inc.)