Table 1.
Baseline Characteristics of the Study Participants [Mean ± SD or N(%)]
|
E + P |
E alone |
|||||
| Placebo (N = 441) | Treatment (N = 503) | P | Placebo (N = 447) | Treatment (N = 422) | P | |
| Age at screening (yr) | 63.7 ± 7.0 | 63.4 ± 7.3 | 0.589 | 63.5 ± 7.6 | 63.4 ± 7.7 | 0.878 |
| Years since menopause | 14.2 ± 8.1 | 14.3 ± 9.4 | 0.877 | 19.4 ± 10.1 | 19.4 ± 10.0 | 0.943 |
| Height (kg) | 161.5 ± 5.9 | 161.4 ± 5.9 | 0.724 | 161.5 ± 6.1 | 160.9 ± 6.3 | 0.122 |
| Weight (cm) | 73.9 ± 16.2 | 73.1 ± 14.4 | 0.406 | 77.8 ± 15.6 | 77.8 ± 15.6 | 0.970 |
| Body mass index (kg/m2) | 28.3 ± 5.8 | 28.1 ± 5.2 | 0.491 | 29.8 ± 5.6 | 30.0 ± 5.6 | 0.478 |
| Dietary energy (kcal) | 1696.0 ± 713.4 | 1717.0 ± 700.9 | 0.655 | 1673.0 ± 767.6 | 1679.6 ± 740.9 | 0.900 |
| Total expenditure from physical activity(METS) | 12.2 ± 14.7 | 10.9 ±13.2 | 0.223 | 9.4 ±11.5 | 10.0 ± 13.0 | 0.501 |
| Total calcium intake (mg) | 1036.5 ± 33.1 | 1029.7 ± 30.4 | 0.880 | 922.7 ± 28.1 | 956.6 ± 32.1 | 0.427 |
| Total vitamin D intake (μg) | 8.9 ± 0.4 | 8.7 ± 0.3 | 0.71 | 7.8 ± 0.3 | 8.0 ± 0.3 | 0.723 |
| Total body lean mass (kg) | 38.2 ± 5.5 | 37.7 ± 5.1 | 0.150 | 38.8 ± 5.6 | 38.5 ± 5.5 | 0.442 |
| Total body percent fat (%) | 43.5 ± 7.3 | 43.8 ± 7.2 | 0.515 | 45.7 ± 6.5 | 46.1 ± 6.7 | 0.396 |
| Hologic total body BMD (g/cm2) | 0.99 ± 0.10 | 0.99 ± 0.10 | 0.769 | 1.01 ± 0.11 | 1.00 ± 0.11 | 0.549 |
| Hologic spine BMD (g/cm2) | 0.95 ± 0.16 | 0.94 ± 0.15 | 0.261 | 0.98 ± 0.17 | 0.97 ± 0.16 | 0.622 |
| Hologic hip BMD (g/cm2) | 0.84 ± 0.14 | 0.83 ± 0.12 | 0.374 | 0.86 ± 0.15 | 0.86 ± 0.13 | 0.852 |
| Ethnicity | ||||||
| White | 363 (82.3%) | 418 (83.1%) | 0.039 | 317 (70.9%) | 317 (75.1%) | 0.123 |
| Black | 50 (11.3%) | 38 (7.6%) | 93 (20.8%) | 67 (15.9%) | ||
| Hispanic | 20 (4.5%) | 36 (7.2%) | 32 (7.2%) | 31 (7.4%) | ||
| Native American | 6 (1.4%) | 3 (0.6%) | 4 (0.9%) | 3 (0.7%) | ||
| Asian/Pacific Islander | 0 (0.00%) | 4 (0.8%) | 1 (0.2%) | 0 (0.0%) | ||
| Other | 2 (0.5%) | 4 (0.8%) | 0 (0.0%) | 4 (1.0%) | ||
| Smoking | ||||||
| Never | 225 (52.7%) | 239 (56.9%) | 0.797 | 238 (54.0%) | 239 (56.9%) | 0.686 |
| Past | 160 (37.5%) | 177 (35.5%) | 151 (34.2%) | 135 (32.1%) | ||
| Current | 42 (9.8%) | 53 (10.6%) | 52 (11.8%) | 46 (11.0%) | ||
| Physical function | ||||||
| <90 | 263 (61.7%) | 302 (60.9%) | 0.792 | 310 (70.5%) | 302 (73.8%) | 0.272 |
| ≥90 | 163 (38.3%) | 194(39.1%) | 130 (29.6%) | 107 (26.2%) | ||
| Hormone use | ||||||
| Never | 347 (78.7%) | 397 (79.1%) | 0.851 | 281 (62.9%) | 251 (59.5%) | 0.130 |
| Past | 76 (17.2%) | 88 (17.5%) | 133 (29.8%) | 149 (35.3%) | ||
| Current | 18 (4.1%) | 17 (3.4%) | 33 (7.4%) | 22 (5.2%) | ||
| Duration of prior hormone use | ||||||
| None | 347 (78.7%) | 397 (78.9%) | 0.922 | 281 (62.9%) | 251 (59.5%) | 0.867 |
| <5 yr | 70 (15.9%) | 81 (16.1%) | 99 (22.2%) | 105 (24.9%) | ||
| 5 to <10 yr | 13 (3.0%) | 14 (2.8%) | 32 (7.2%) | 33 (7.8%) | ||
| 10 to <15 yr | 8 (1.8%) | 6 (1.2%) | 14 (3.1%) | 14 (3.3%) | ||
| 15+ yr | 3 (0.7%) | 5 (1.0%) | 21 (4.7%) | 19 (4.5%) | ||