FREEDOM baseline | Extension baseline | End of year 8 | ||||
---|---|---|---|---|---|---|
Placebo (N = 3906) |
Denosumab (N = 3902) |
Crossover denosumab (N = 2207) |
Long-term denosumab (N = 2343) |
Crossover denosumab (N = 1462) |
Long-term denosumab (N = 1542) | |
Age, years | ||||||
Mean (SD) | 72.3 (5.2)^{a} | 72.3 (5.2)^{a} | 74.8 (5.1)^{b} | 74.9 (5.0)^{b} | 79.0 (4.8) | 79.1 (4.7) |
Median (range) | 72 (60–91) | 72 (60–90) | 75 (63–93) | 75 (63–93) | 79 (68–98) | 79 (68–94) |
Age group, n (%) | ||||||
≥ 70 years | 2878 (74) | 2872 (74) | 1823 (83) | 1974 (84) | 1420 (97) | 1505 (98) |
≥ 75 years | 1236 (32)^{a} | 1235 (32)^{a} | 1151 (52)^{b} | 1258 (54)^{b} | 1160 (79) | 1255 (81) |
≥ 80 years | 346 (9) | 322 (8) | 379 (17) | 407 (17) | 676 (46) | 737 (48) |
Prior fracture, n (%) | ||||||
Prior vertebral | 915 (23)^{a} | 929 (24)^{a} | 551 (25)^{b,c} | 573 (24)^{b,c} | NA | NA |
Prior nonvertebral^{d} | 1177 (30) | 1163 (30) | 754 (34)^{c} | 780 (33)^{c} | NA | NA |
BMD T-score, mean (SD) | ||||||
Lumbar spine | –2.8 (0.7)^{a} | –2.8 (0.7)^{a} | –2.8 (0.8)^{b} | –2.1 (0.8)^{b} | –1.9 (0.9) | –1.6 (0.9) |
Total hip | –1.9 (0.8)^{a} | –1.9 (0.8)^{a} | –1.9 (0.8)^{b} | –1.5 (0.8)^{b} | –1.5 (0.8) | –1.3 (0.8) |