Table 1.

Characteristics of the Patients.^*

Characteristic	Tibolone (N = 2267)	Placebo (N = 2267)
Age
Mean — yr	68.3±5.2	68.2±5.2
≤69 yr — no. (%)	1352 (60)	1349 (60)
≥70 yr — no. (%)	915 (40)	918 (40)
Body-mass index	25.7±3.4	25.7±3.4
Previous hormone therapy — no. (%)	482 (21)	461 (20)
Family history of breast cancer — no. (%)†	208 (9)	223 (10)
Current smoker — no. (%)	289 (13)	254 (11)
Hypertension — no. (%)	807 (36)	806 (36)
Diabetes — no. (%)	106 (5)	115 (5)
Prevalent vertebral fracture — no. (%)	607 (27)	584 (26)
Previous nonvertebral fracture — no. (%)	528 (23)	479 (21)
Bone mineral density T score‡
Total hip	−1.8±0.78	−1.8±0.79
Lumbar spine	−2.9±0.61	−2.9±0.55
Intact uterus — no. (%)	1746 (77)	1773 (78)

^*Plus–minus values are means ±SD. The total numbers of patients in each group include all those who underwent randomization with the use of an interactive voice-response system, although 18 patients in the tibolone group and 10 in the placebo group did not receive a study drug. The body-mass index is the weight in kilograms divided by the square of the height in meters.

^†Patients had a history of breast cancer in a first-degree female relative.

^‡Measurements of bone mineral density that were obtained with the use of Lunar and Hologic densitometers were standardized for comparability.