Placebo (N = 3906) | Denosumab (N = 3902) | Combined (N = 7808) | ||||
---|---|---|---|---|---|---|
Extension nonparticipants (N = 1699) | Extension enrollees (N = 2207) | Extension nonparticipants (N = 1559) | Extension enrollees (N = 2343) | Extension nonparticipants (N = 3258) | Extension enrollees (N = 4550) | |
Age, years | ||||||
Mean (SD) | 73.1 (5.3) | 71.8 (5.1)a | 73.0 (5.4) | 71.9 (5.0)a,b | 73.1 (5.4) | 71.8 (5.0) |
Median (range) | 73 (60–91) | 72 (60–90) | 73 (60–89) | 72 (60–90) | 73 (60–91) | 72 (60–90) |
Age group, n (%) | ||||||
≥ 70 years | 1307 (77) | 1571 (71) | 1200 (77) | 1672 (71) | 2507 (77) | 3243 (71) |
≥ 75 years | 612 (36) | 624 (28)a | 573 (37) | 662 (28)a,b | 1185 (36) | 1286 (28) |
≥ 80 years | 203 (12) | 143 (6) | 178 (11) | 144 (6) | 381 (12) | 287 (6) |
Prior fracture, n (%) | ||||||
Prior vertebral | 430 (25) | 485 (23)a | 370 (24) | 559 (24)a,b | 800 (25) | 1044 (23) |
Prior nonvertebralc | 526 (31) | 651 (29) | 461 (30) | 702 (30)b | 987 (30) | 1353 (30) |
BMD T-score, mean (SD) | ||||||
Lumbar spine | –2.8 (0.7) | –2.8 (0.7)a | –2.8 (0.7) | –2.8 (0.7)a,b | –2.8 (0.7) | –2.8 (0.7) |
Total hip | –2.0 (0.8) | –1.9 (0.8)a | –1.9 (0.8) | –1.9 (0.8)a,b | –2.0 (0.8) | –1.9 (0.8) |
FRAX® probability,d %, mean (SD) | ||||||
Hip | 7.4 (7.7) | 6.6 (7.3) | 7.5 (8.0) | 6.8 (7.2) | 7.4 (7.8) | 6.7 (7.3) |
Major osteoporotic | 17.8 (9.8) | 16.8 (9.7) | 17.6 (9.9) | 17.0 (9.6) | 17.7 (9.8) | 16.9 (9.6) |