Baseline variables
| No. Placebo (%) | No. Denosumab (%) | |||
|---|---|---|---|---|
| Age: | ||||
| Younger than 70 | 124 | (17) | 125 | (17) |
| 70 or Older | 610 | (83) | 609 | (83) |
| BMI (kg/m2): | ||||
| Less than 26 | 250 | (34) | 223 | (30) |
| 26 or Greater | 483 | (66) | 510 | (70) |
| Unknown | 1 | (less than 1) | 1 | (less than 1) |
| Prevalent vertebral fracture: | ||||
| Yes | 174 | (24) | 155 | (21) |
| No | 504 | (69) | 531 | (72) |
| Not readable or missing | 56 | (8) | 48 | (7) |
| Lumbar spine BMD T score: | ||||
| −1.0 or Less | 321 | (44) | 276 | (38) |
| Greater than −1.0 | 408 | (56) | 451 | (61) |
| Unknown | 5 | (less than 1) | 7 | (1) |
| Total hip BMD T score: | ||||
| −1.0 or Less | 359 | (49) | 339 | (46) |
| Greater than −1.0 | 359 | (49) | 373 | (51) |
| Unknown | 16 | (2) | 22 | (3) |
| Distal 1/3 radius BMD T score (substudy):* | ||||
| −1.0 or Less | 125 | (84) | 128 | (80) |
| Greater than −1.0 | 10 | (7) | 16 | (10) |
| Unknown | 13 | (9) | 17 | (11) |
| Mos prior ADT: | ||||
| 0–6 | 175 | (24) | 175 | (24) |
| Greater than 6 | 559 | (76) | 559 | (76) |
| Type of prior ADT: | ||||
| GnRH agonist | 671 | (91) | 655 | (89) |
| Bilat orchiectomy | 61 | (8) | 77 | (10) |
| Unknown | 2 | (less than 1) | 2 | (less than 1) |
| sCTx levels (μg/l): | ||||
| Less than 0.475 | 231 | (31) | 221 | (30) |
| 0.475–Less than 0.764 | 236 | (32) | 229 | (31) |
| 0.764 or Greater | 216 | (29) | 240 | (33) |
| Not available | 51 | (7) | 44 | (6) |
| TRAP-5b levels (U/l): | ||||
| Less than 4.219 | 228 | (31) | 225 | (31) |
| 4.219–Less than 5.561 | 230 | (31) | 236 | (32) |
| 5.561 or Greater | 223 | (30) | 231 | (31) |
| Not available | 53 | (7) | 42 | (6) |
*
In 148 placebo and 161 denosumab.