Table 2.
Baseline outcomes by gender and randomization arm
| Characteristics | Men N = 328 |
p-value | Women N = 480 |
p-value | ||
|---|---|---|---|---|---|---|
| ILI | DSE | ILI | DSE | |||
| Total Hip BMD (g/cm2) | 1.07 (0.12) | 1.09 (0.14) | 0.2966 | 1.04 (0.14) | 1.04 (0.14) | 0.7855 |
| Femoral Neck BMD (g/cm2) | 0.86 (0.12) | 0.88 (0.12) | 0.2839 | 0.87 (0.14) | 0.88 (0.14) | 0.5717 |
| Lumbar Spine BMD (g/cm2) | 1.13 (0.15) | 1.17 (0.18) | 0.0196 | 1.10 (0.17) | 1.12 (0.16) | 0.2100 |
| Whole Body BMD (g/cm2) | 1.18 (0.10) | 1.19 (0.12) | 0.3145 | 1.13 (0.12) | 1.14 (0.12) | 0.7056 |
| Total Hip BMD T-score | 0.81 (1.04) | 1.05 (1.23) | 0.0635 | 0.27 (1.23) | 0.26 (1.33) | 0.9800 |
| Lumbar Spine BMD T-score | 1.21 (1.54) | 1.60 (1.93) | 0.0420 | 0.38 (1.66) | 0.47 (1.49) | 0.5112 |
| Total Hip BMD* | 0.8734 | 0.1135 | ||||
| Normal range | 148 (96.7%) | 161 (96.4%) | 199 (86.2%) | 194 (80.8%) | ||
| Low bone density | 5 (3.3%) | 6 (3.6%) | 29 (12.6%) | 45 (18.8%) | ||
| Osteoporosis | 0 (0.0%) | 0 (0.0%) | 3 (1.3%) | 1 (0.4%) | ||
| Lumbar Spine BMD* | 0.7727 | 0.6038 | ||||
| Normal range | 141 (92.8%) | 159 (91.9%) | 188 (80.0%) | 202 (82.5%) | ||
| Low bone density | 11 (7.2%) | 14 (8.1%) | 43 (18.3%) | 41 (16.7%) | ||
| Osteoporosis | 0 (0.0%) | 0 (0.0%) | 4 (1.7%) | 2 (0.8%) | ||
*Low bone density is defined as having a BMD T-score between -2.5 and -1.0; Osteoporosis is defined as having a BMD T-score < -2.5