Table 2.
Average Number of Days and n (%) of Women Experiencing ≥7 Days of Back Pain by Treatment and Prevalent Vertebral Fracture
| Back pain
|
||||||
|---|---|---|---|---|---|---|
| Any back pain
|
Moderate or worse
|
Severe or worse
|
||||
| Days, mean ± SDa | ≥7 days, n (%) of womenb | Days, mean ± SDa | ≥7 days, n (%) of womenb | Days, mean ± SDa | ≥7 days, n (%) of womenb | |
| Overall treatment | 272.5 ± 303.1 | 6450 (83.6) | 202.6 ± 278.8 | 5280 (68.4) | 46.4 ± 134.1 | 1978 (25.6) |
| Zoledronic acid | 263.6 ± 299.8 | 3190 (82.6) | 194.9 ± 274.4 | 2598 (67.3) | 44.5 ± 130.2 | 948 (24.6) |
| Placebo | 281.5 ± 306.2 | 3260 (84.6) | 210.3 ± 283.1 | 2682 (69.6) | 48.4 ± 138.0 | 1030 (26.7) |
| LS mean difference (95% CI)a | −18.0 (−31.5, −4.4) | −15.4 (−27.9, −3.0) | −3.9 (−9.9, 2.1) | |||
| RR (95% CI)b | 0.94 (0.90, 0.99) | 0.95 (0.90,1.00) | 0.92 (0.84,1.00) | |||
| p Value | .009 | .020 | .015 | .049 | .198 | .059 |
| Prevalent vertebral fracture (Yes) | ||||||
| Total | 294.2 ± 312.2 | 4155 (85.2) | 219.6 ± 289.5 | 3441 (70.5) | 51.2 ± 141.7 | 1327 (27.2) |
| Zoledronic acid | 284.7 ± 311.2 | 2011 (83.5) | 212.1 ± 286.4 | 1653 (68.6) | 49.2 ± 137.2 | 629 (26.1) |
| Placebo | 303.4 ± 313.0 | 2144 (86.8) | 226.9 ± 292.3 | 1788 (72.4) | 53.3 ± 146.1 | 698 (28.2) |
| LS mean difference (95% CI)a | −18.8 (−36.3, −1.2) | −14.9 (−31.1, 1.4) | −4.1 (−12.1, 3.9) | |||
| RR (95% CI)b | 0.93 (0.87, 0.99) | 0.93 (0.87, 0.99) | 0.93 (0.83, 1.03) | |||
| p value | .036 | .018 | .073 | .026 | .313 | .161 |
| Prevalent vertebral fracture (No) | ||||||
| Total | 235.2 ± 283.0 | 2292 (80.9) | 173.2 ± 256.8 | 1836 (64.8) | 38.0 ± 119.4 | 648 (22.9) |
| Zoledronic acid | 228.7 ± 276.7 | 1177 (81.1) | 166.5 ± 250.9 | 943 (65.0) | 36.6 ± 117.5 | 317 (21.8) |
| Placebo | 242.0 ± 289.3 | 1115 (80.7) | 180.2 ± 262.8 | 893 (64.7) | 39.5 ± 121.5 | 331 (24.0) |
| LS mean difference (95% CI)a | −13.3 (−34.2, 7.5) | −13.7 (−32.6, 5.2) | −2.9 (−11.7, 5.9) | |||
| RR (95% CI)b | 0.98 (0.90,1.06) | 0.99 (0.91,1.09) | 0.91 (0.78, 1.06) | |||
| p Value | .210 | .611 | .156 | .910 | .522 | .233 |
SD = standard deviation; LS = least squares; RR = relative risk; CI = confidence interval.
a
LS mean difference and p value are calculated using one-way ANOVA.
b
RR and p value are calculated using Cox regression.