TABLE 1.
Baseline characteristics of subjects in overall population (strata I and II combined)
| Zoledronic acid | Placebo | |
|---|---|---|
| n | 3875 | 3861 |
| Age (yr) | 73.1 ± 5.3 | 73.0 ± 5.4 |
| Age group | ||
| <70 yr | 1140 (29.4) | 1174 (30.4) |
| 70–74 yr | 1238 (31.9) | 1235 (32.0) |
| ≥75 yr | 1497 (38.6) | 1452 (37.6) |
| Age at menopause (yr) | 48.0 ± 5.5 | 47.9 ± 5.5 |
| Stratum | ||
| I | 3045 (78.6) | 3039 (78.7) |
| II | 830 (21.4) | 822 (21.3) |
| Race | ||
| Caucasian | 3054 (78.8) | 3055 (79.1) |
| Asian | 562 (14.5) | 559 (14.5) |
| Other | 259 (6.7) | 247 (6.4) |
| Region | ||
| Americas | 1391 (35.9) | 1387 (35.9) |
| Asia | 550 (14.2) | 540 (14.0) |
| Europe | 1934 (49.9) | 1934 (50.1) |
| BMI (kg/m2)a | 25.1 ± 4.3 | 25.4 ± 4.3 |
| BMIa | ||
| <18 kg/m2 | 98 (2.5) | 91 (2.4) |
| 18–24.9 kg/m2 | 1969 (50.9) | 1845 (47.8) |
| 25–29.9 kg/m2 | 1333 (34.5) | 1420 (36.8) |
| ≥30 kg/m2 | 468 (12.1) | 500 (13.0) |
| Weight (kg)a | 59.9 ± 11.1 | 60.6 ± 11.3 |
| Height loss | ||
| <−5.65 cm | 1243 (32.9) | 1276 (33.8) |
| −5.65 to −3 cm | 1283 (34.0) | 1242 (32.9) |
| >−3 cm | 1253 (33.2) | 1262 (33.4) |
| Baseline VFx | ||
| Yes | 2416 (62.4) | 2477 (64.2) |
| No | 1457 (37.6) | 1383 (35.8) |
| Current smoker | ||
| Yes | 344 (8.9) | 316 (8.2) |
| No | 3531 (91.1) | 3544 (91.8) |
| History of falls | ||
| Yes | 1139 (29.5) | 1130 (29.3) |
| No | 2706 (70.0) | 2711 (70.3) |
| Unknown | 20 (0.5) | 15 (0.4) |
| Physical activity (hours walking/wk) | 19.6 ± 18.0 | 19.8 ± 17.9 |
| Prior bisphosphonate usage | ||
| Yes | 565 (14.6) | 557 (14.4) |
| No | 3293 (85.1) | 3282 (85.1) |
| Total hip BMD (g/cm2) | 0.65 ± 0.09 | 0.65 ± 0.09 |
| Standardized total hip BMD (g/cm2) | ||
| 0.23–0.61 | 1290 (33.6) | 1262 (32.9) |
| >0.61–0.68 | 1301 (33.8) | 1276 (33.2) |
| >0.68–1.32 | 1253 (32.6) | 1301 (33.9) |
| Femoral neck BMD (g/cm2) | 0.53 ± 0.06 | 0.53 ± 0.06 |
| Femoral neck T-score | −2.8 ± 0.5 | −2.7 ± 0.6 |
| Femoral neck T-score | ||
| ≤−2.5 | 2814 (73.1) | 2734 (71.1) |
| >−2.5 | 1037 (26.9) | 1111 (28.9) |
| Femoral neck T-score by baseline VFx status | ||
| ≤−2.5 + VFx | 1649 (42.8) | 1645 (42.8) |
| ≤−2.5 − VFx | 1163 (30.2) | 1088 (28.3) |
| >−2.5 + VFx | 751 (19.5) | 822 (21.4) |
| >−2.5 − VFx | 286 (7.4) | 289 (7.5) |
| Creatinine clearance | ||
| <60 ml/min | 1786 (46.1) | 1728 (44.8) |
| ≥60 ml/min | 2089 (53.9) | 2133 (55.2) |
Data are presented as mean ± SD or number (%). VFx, Vertebral fracture.
a
Significant difference (P < 0.05) between treatment groups (t test for continuous variables; χ2 test for categorical variables).