Table 4.
Cumulative Analyzed Incidence Rates for Clinical Outcomes in the Women's Health Initiative Calcium and Vitamin D Supplementation Trial: Stratified by Personal Use of Calcium Supplements (With or Without Vitamin D) at Calcium and Vitamin D Randomization
|
Overall combined phases |
||||||
---|---|---|---|---|---|---|---|
|
CaD |
Placebo |
|
|
|
||
N | % | N | % | HR* | (95% CI)a | p-valuea | |
Hip fracture | 0.28 | ||||||
No | 153 | 0.16 | 180 | 0.20 | 0.84 | (0.67, 1.04) | |
Yes | 226 | 0.21 | 233 | 0.22 | 0.96 | (0.80, 1.16) | |
Vertebral fractureb | 0.76 | ||||||
No | 172 | 0.18 | 192 | 0.21 | 0.89 | (0.72, 1.09) | |
Yes | 274 | 0.25 | 316 | 0.29 | 0.84 | (0.71, 0.99) | |
Total fractureb | 0.71 | ||||||
No | 1765 | 2.08 | 1733 | 2.09 | 1.00 | (0.93, 1.06) | |
Yes | 2248 | 2.31 | 2285 | 2.35 | 0.98 | (0.92, 1.04) | |
Invasive colorectal cancer | 0.18 | ||||||
No | 111 | 0.12 | 131 | 0.14 | 0.85 | (0.66, 1.10) | |
Yes | 145 | 0.13 | 136 | 0.13 | 1.05 | (0.83, 1.32) | |
Invasive breast cancer | 0.16 | ||||||
No | 359 | 0.39 | 366 | 0.41 | 0.96 | (0.83, 1.11) | |
Yes | 492 | 0.47 | 450 | 0.42 | 1.10 | (0.97, 1.25) | |
In situ breast cancer | 0.17 | ||||||
No | 76 | 0.08 | 106 | 0.12 | 0.69 | (0.52, 0.93) | |
Yes | 122 | 0.12 | 132 | 0.13 | 0.91 | (0.71, 1.16) | |
Total cancer | 0.04 | ||||||
No | 1126 | 1.27 | 1204 | 1.40 | 0.91 | (0.84, 0.99) | |
Yes | 1428 | 1.40 | 1413 | 1.38 | 1.02 | (0.94, 1.09) | |
Coronary heart disease | 0.34 | ||||||
No | 453 | 0.49 | 415 | 0.46 | 1.08 | (0.95, 1.23) | |
Yes | 424 | 0.40 | 430 | 0.40 | 0.99 | (0.86, 1.13) | |
Coronary heart disease deathc | 0.55 | ||||||
No | 130 | 0.14 | 136 | 0.15 | 0.95 | (0.75, 1.22) | |
Yes | 138 | 0.13 | 129 | 0.12 | 1.03 | (0.81, 1.32) | |
Clinical myocardial infarction | 0.17 | ||||||
No | 347 | 0.38 | 309 | 0.34 | 1.11 | (0.95, 1.29) | |
Yes | 312 | 0.29 | 328 | 0.31 | 0.96 | (0.82, 1.12) | |
Stroke | 0.30 | ||||||
No | 340 | 0.37 | 305 | 0.34 | 1.11 | (0.95, 1.30) | |
Yes | 350 | 0.33 | 354 | 0.33 | 0.99 | (0.85, 1.15) | |
Cardiovascular disease death | 0.60 | ||||||
No | 262 | 0.28 | 257 | 0.28 | 1.00 | (0.84, 1.19) | |
Yes | 287 | 0.26 | 268 | 0.25 | 1.06 | (0.90, 1.25) | |
Total death | 0.38 | ||||||
No | 852 | 0.91 | 845 | 0.92 | 0.99 | (0.90, 1.09) | |
Yes | 923 | 0.85 | 978 | 0.90 | 0.94 | (0.86, 1.02) | |
Global index | 0.55 | ||||||
No | 1325 | 1.46 | 1379 | 1.56 | 0.94 | (0.87, 1.02) | |
Yes | 1607 | 1.54 | 1616 | 1.54 | 0.97 | (0.91, 1.04) |
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.
Coronary heart disease death includes definite and possible coronary heart disease death.