Parameter | Estimate | Std error | Χ2 | DF | Pvalue | Hazard ratio | 95% Confidence limits |
|---|
Tibolone | 0.50 | 0.26 | 3.75 | 1 | 0.05 | 1.64 | 0.99, 2.72 |
BMI | -0.01 | 0.03 | 0.07 | 1 | 0.79 | 0.99 | 0.93, 1.06 |
Osteopenia (T-score ≤ -1) | -0.57 | 0.27 | 4.41 | 1 | 0.04 | 0.57 | 0.34, 0.96 |
- These results are restricted to subjects with any BMD assessment, using a proportional hazard Cox model with Treatment, Osteopenia (defined as T-score ≤ -1) as time-dependent factors and Body mass index (BMI) as covariate. For those patients with baseline and either 2-year or second BMD measurements at trial end, an analysis was carried out to correct for changes in BMD on treatment. Osteopenic and osteoporotic patients were grouped together to take account of changes in BMD during the course of the trial. Tibolone use in women with normal BMD values was associated with increased breast cancer recurrence with a Hazard Ratio that reached significance.
