Table 3.
|
Overall combined phases |
||||||
---|---|---|---|---|---|---|---|
|
CaD |
Placebo |
|
|
|
||
N | % | N | % | HRa | (95% CI)a | p-valuea | |
Hip fracture | 0.97 | ||||||
<200 | 138 | 0.18 | 140 | 0.19 | 0.93 | (0.74, 1.18) | |
200–<400 | 68 | 0.18 | 75 | 0.20 | 0.95 | (0.68, 1.33) | |
400–<600 | 80 | 0.17 | 112 | 0.24 | 0.74 | (0.55, 0.98) | |
≥600 | 87 | 0.23 | 77 | 0.21 | 1.07 | (0.79, 1.46) | |
Vertebral fractureb | 0.70 | ||||||
<200 | 143 | 0.19 | 156 | 0.21 | 0.88 | (0.70, 1.11) | |
200–<400 | 79 | 0.21 | 93 | 0.25 | 0.85 | (0.63, 1.15) | |
400–<600 | 100 | 0.22 | 127 | 0.27 | 0.78 | (0.60, 1.01) | |
≥600 | 116 | 0.31 | 127 | 0.35 | 0.84 | (0.65, 1.08) | |
Total fractureb | 0.95 | ||||||
<200 | 1456 | 2.11 | 1391 | 2.09 | 1.01 | (0.93, 1.08) | |
200–<400 | 708 | 2.07 | 771 | 2.25 | 0.93 | (0.84, 1.03) | |
400–<600 | 966 | 2.32 | 967 | 2.26 | 1.03 | (0.94, 1.13) | |
≥600 | 814 | 2.38 | 816 | 2.46 | 0.98 | (0.89, 1.08) | |
Invasive colorectal cancer | 0.72 | ||||||
<200 | 91 | 0.12 | 95 | 0.13 | 0.95 | (0.71, 1.27) | |
200–<400 | 46 | 0.12 | 60 | 0.16 | 0.79 | (0.54, 1.17) | |
400–<600 | 70 | 0.15 | 60 | 0.13 | 1.21 | (0.85, 1.71) | |
≥600 | 43 | 0.11 | 48 | 0.13 | 0.84 | (0.56, 1.28) | |
Invasive breast cancer | 0.03 | ||||||
<200 | 276 | 0.37 | 300 | 0.42 | 0.89 | (0.76, 1.05) | |
200–<400 | 178 | 0.49 | 168 | 0.45 | 1.10 | (0.89, 1.36) | |
400–<600 | 203 | 0.45 | 196 | 0.42 | 1.04 | (0.85, 1.27) | |
≥600 | 181 | 0.49 | 139 | 0.38 | 1.28 | (1.03, 1.60) | |
In situ breast cancer | 0.31 | ||||||
<200 | 73 | 0.10 | 81 | 0.11 | 0.87 | (0.64, 1.20) | |
200–<400 | 37 | 0.10 | 45 | 0.12 | 0.83 | (0.54, 1.28) | |
400–<600 | 44 | 0.10 | 66 | 0.14 | 0.66 | (0.45, 0.97) | |
≥600 | 39 | 0.11 | 40 | 0.11 | 0.91 | (0.58, 1.42) | |
Total cancer | 0.07 | ||||||
<200 | 888 | 1.23 | 942 | 1.36 | 0.91 | (0.83, 0.99) | |
200–<400 | 503 | 1.42 | 542 | 1.52 | 0.94 | (0.83, 1.06) | |
400–<600 | 588 | 1.34 | 611 | 1.36 | 0.98 | (0.88, 1.10) | |
≥600 | 529 | 1.49 | 472 | 1.34 | 1.11 | (0.98, 1.26) | |
Coronary heart disease | 0.16 | ||||||
<200 | 339 | 0.45 | 338 | 0.47 | 0.96 | (0.82, 1.11) | |
200–<400 | 142 | 0.38 | 166 | 0.44 | 0.86 | (0.69, 1.08) | |
400–<600 | 213 | 0.46 | 184 | 0.39 | 1.19 | (0.98, 1.46) | |
≥600 | 159 | 0.42 | 136 | 0.37 | 1.13 | (0.90, 1.43) | |
Stroke | 0.68 | ||||||
<200 | 242 | 0.32 | 227 | 0.31 | 1.03 | (0.86, 1.24) | |
200–<400 | 128 | 0.34 | 127 | 0.34 | 1.08 | (0.84, 1.38) | |
400–<600 | 174 | 0.38 | 153 | 0.32 | 1.18 | (0.95, 1.47) | |
≥600 | 130 | 0.34 | 132 | 0.36 | 0.97 | (0.76, 1.24) | |
Total death | 0.19 | ||||||
<200 | 632 | 0.83 | 655 | 0.89 | 0.93 | (0.83, 1.03) | |
200–<400 | 312 | 0.83 | 352 | 0.92 | 0.91 | (0.78, 1.06) | |
400–<600 | 410 | 0.88 | 429 | 0.90 | 0.98 | (0.85, 1.12) | |
≥600 | 376 | 0.99 | 341 | 0.92 | 1.07 | (0.92, 1.24) | |
Global index | 0.13 | ||||||
<200 | 1025 | 1.39 | 1073 | 1.51 | 0.92 | (0.84, 1.00) | |
200–<400 | 533 | 1.47 | 597 | 1.63 | 0.90 | (0.80, 1.01) | |
400–<600 | 691 | 1.54 | 709 | 1.55 | 1.01 | (0.91, 1.13) | |
≥600 | 617 | 1.69 | 550 | 1.53 | 1.04 | (0.93, 1.17) |
From a proportional hazards model stratified by prevalent condition (where appropriate), age, hormone therapy and diet modification randomization arm, and trial phase (time-dependent). Time to event equals 0 on date of randomization.
All nonhip fractures use adjudicated data during the clinical trial and self-reported data thereafter.