Table 2.
Hazard Ratios for the Primary, Secondary, and Exploratory End Points, According to Randomized Assignment to Vitamin D or Placebo, in Intention-to-Treat Analyses.*
End Point | Vitamin D Group (N = 12,927) | Placebo Group (N = 12,944) | Hazard Ratio (95% CI) |
---|---|---|---|
no. of participants with event | |||
Primary end points: confirmed incident fractures | |||
Total | 769 | 782 | 0.98 (0.89–1.08) |
Nonvertebral | 721 | 744 | 0.97 (0.87–1.07) |
Hip | 57 | 56 | 1.01 (0.70–1.47) |
Secondary end points: confirmed incident fractures excluding toe, finger, skull, periprosthetic, and pathologic fractures | |||
Total | 678 | 685 | 0.99 (0.89–1.10) |
Nonvertebral | 630 | 649 | 0.97 (0.87–1.08) |
Hip | 54 | 52 | 1.03 (0.70–1.52) |
Exploratory end points: confirmed incident fractures excluding periprosthetic and pathologic fractures | |||
Major osteoporotic fractures: hip, wrist, humerus, or clinical spine fractures | 276 | 278 | 0.99 (0.83–1.17) |
Pelvic | 32 | 29 | 1.08 (0.64–1.80) |
Wrist | 118 | 132 | 0.89 (0.69–1.15) |
Analyses were performed with the use of Cox proportional-hazards models that were adjusted for age, sex, race or ethnic group, and n–3 fatty acid randomization group. Confidence intervals were not adjusted for multiple comparisons, and inferences drawn from them may not be reproducible.