Table 3.
Effects of Tibolone on New Factures, According to the Presence or Absence of a Vertebral Fracture at Baseline.*
| Variable | Tibolone (N = 2059) | Placebo (N = 2087) | Relative Hazard (95% CI) | P Value | Risk Difference in Tibolone Group (95% CI)† | |||
|---|---|---|---|---|---|---|---|---|
|
| ||||||||
| Treatment | Interaction | |||||||
|
| ||||||||
| no. of events | no. of cases per 1000 person-years | no. of events | no. of cases per 1000 person-years | no. of cases per 1000 person-years | ||||
|
| ||||||||
| New vertebral fracture | ||||||||
|
| ||||||||
| No prevalent vertebral fracture | 47 | 10.0 | 70 | 14.6 | 0.69 (0.48 to 1.00) | 0.05 | 0.07 | −4.6 (− 9.0 to −0.1) |
|
| ||||||||
| Prevalent vertebral fracture | 23 | 13.6 | 56 | 34.3 | 0.39 (0.24 to 0.63) | <0.001 | −20.8 (− 31.3 to −10.2) | |
| Nonvertebral fracture | ||||||||
|
| ||||||||
| No prevalent vertebral fracture | 89 | 19.3 | 106 | 22.5 | 0.86 (0.65 to 1.14) | 0.28 | 0.07 | −3.2 (− 9.1 to 2.7) |
|
| ||||||||
| Prevalent vertebral fracture | 33 | 20.0 | 60 | 37.7 | 0.53 (0.35 to 0.81) | 0.004 | −17.7 (− 29.4 to −6.0) | |
*
The analysis includes all patients who had undergone radiography at baseline and during at least one follow-up visit.
†
Values may not equal numerical differences because of rounding.