TABLE 2.
Baseline characteristics for patients in stratum I
| Zoledronic acid | Placebo | |
|---|---|---|
| n | 2822 | 2853 |
| Age (yr) | 73.0 ± 5.2 | 3.1 ± 5.4 |
| Age group | ||
| <70 yr | 832 (29.5) | 852 (29.9) |
| 70–74 yr | 907 (32.1) | 923 (32.4) |
| ≥75 yr | 1083 (38.4) | 1078 (37.8) |
| Age at menopause (yr) | 48.2 ± 5.3 | 48.0 ± 5.4 |
| Race | ||
| Caucasian | 2135 (75.7) | 2179 (76.4) |
| Asian | 482 (17.1) | 477 (16.7) |
| Other | 205 (7.3) | 197 (6.9) |
| Region | ||
| Americas | 917 (32.5) | 931 (32.6) |
| Asia | 473 (16.8) | 461 (16.2) |
| Europe | 1432 (50.7) | 1461 (51.2) |
| BMI (kg/m2)a | 25.2 ± 4.2 | 25.5 ± 4.3 |
| BMI | ||
| <18 kg/m2 | 67 (2.4) | 63 (2.2) |
| 18–24.9 kg/m2 | 1400 (49.7) | 1348 (47.3) |
| 25–29.9 kg/m2 | 1014 (36.0) | 1059 (37.2) |
| ≥30 kg/m2 | 334 (11.9) | 379 (13.3) |
| Weight (kg)a | 59.9 ± 11.0 | 60.6 ± 11.4 |
| Height loss | ||
| <−5.65 cm | 966 (32.7) | 981 (33.0) |
| −5.65 to −3 cm | 1005 (34.0) | 969 (32.6) |
| >−3 cm | 985 (33.3) | 1021 (34.4) |
| Baseline VFx | ||
| Yes | 1752 (62.1) | 1815 (63.6) |
| No | 1070 (37.9) | 1038 (36.4) |
| Current smoker | ||
| Yes | 235 (8.3) | 218 (7.6) |
| No | 2587 (91.7) | 2635 (92.4) |
| History of falls | ||
| Yes | 811 (28.7) | 837 (29.3) |
| No | 1998 (70.8) | 2006 (70.3) |
| Unknown | 13 (0.5) | 10 (0.4) |
| Physical activity (hours walking/wk) | 19.8 ± 17.9 | 20.0 ± 18.0 |
| Prior bisphosphonate usage | ||
| Yes | 335 (11.9) | 339 (11.9) |
| No | 2479 (87.8) | 2502 (87.7) |
| Total hip BMD (g/cm2) | 0.65 ± 0.09 | 0.65 ± 0.09 |
| Standardized total hip BMD (g/cm2) | ||
| 0.23–0.61 | 931 (33.2) | 951 (33.5) |
| >0.61–0.68 | 939 (33.5) | 939 (33.0) |
| >0.68–1.32 | 933 (33.3) | 952 (33.5) |
| Femoral neck BMD (g/cm2) | 0.53 ± 0.06 | 0.53 ± 0.06 |
| Femoral neck T-score | −2.7 ± 0.5 | −2.8 ± 0.5 |
| Femoral neck T-score | ||
| ≤−2.5 | 2037 (72.7) | 2054 (72.3) |
| >−2.5 | 766 (27.3) | 788 (27.7) |
| Femoral neck T-score by baseline VFx status | ||
| ≤−2.5 + VFx | 1185 (42.3) | 1238 (43.6) |
| ≤−2.5 − VFx | 852 (30.4) | 816 (28.7) |
| >−2.5 + VFx | 556 (19.8) | 571 (20.1) |
| >−2.5 − VFx | 210 (7.5) | 217 (7.6) |
| Creatinine clearance | ||
| <60 ml/min | 1289 (45.7) | 1274 (44.7) |
| ≥60 ml/min | 1533 (54.3) | 1579 (55.3) |
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).