LIFT study published in the 14th August issue of the New England Journal of Medicine examined the effect of tibolone in women aged 60-85 on osteoporotic fracture. 4,538 women who had a bone mineral density T score of -2.5 or less at the hip or spine or a T score of -2.0 or less and radiologic evidence of a vertebral fracture were randomized to receive once-daily tibolone (at a dose of 1.25 mg) or placebo. Annual spine radiographs were used to assess for vertebral fracture. Rates of cardiovascular events and breast cancer were adjudicated by expert panels.
During a median of 34 months of treatment, the tibolone group, as compared with the placebo group, had a decreased risk of vertebral and nonvertebral (but not hip) fracture. The tibolone group also had a decreased risk of invasive breast cancer and colon cancer. The tibolone group had an increased risk of stroke for which the study was stopped in February 2006 at the recommendation of the data and safety monitoring board. However, it should be noted that, for the age group studied, the incidence of stroke in the placebo group was 47% lower than that seen in other studies such as the Women’s Health Initiative, for reasons unknown. Thus the findings may reflect a decreased incidence of stroke in the placebo group more than an increased incidence in the tibolone group. There were no significant differences in the risk of either coronary heart disease or venous thromboembolism between the two groups. As with HRT, we would suggest caution in initiating therapy with tibolone in women aged above 60 years.