Table 2.
FREEDOM analysis (3 years) | FREEDOM + Extension analysis (10 years) | ||
---|---|---|---|
Placebo N = 438 | Denosumab N = 272 | Combined denosumab N = 794 | |
Subject-years of follow-up | 532.3 | 357.2 | 2497.5 |
Subjects with ≥ 1 subsequent fracture, n (%) | 54 (12.3) | 24 (8.8) | 144 (18.1) |
Exposure-adjusted subsequent fracture rate, per 100 subject-years | 10.1 | 6.7 | 5.8 |
Median time to subsequent fracture since first incident fracture among subjects with ≥ 1 subsequent fracture, years | 1.0 | 0.8 | 1.9 |
N subjects who received ≥ 2 doses of investigational product, had an osteoporotic fracture on treatment, and remained on study post-fracture, n number of subjects