Ten years of treatment with tibolone 2.5 mg daily: effects on bone loss in postmenopausal women

Objectives To assess the effects of tibolone 2.5 mg daily over a 10-year period on bone loss and other efficacy parameters in postmenopausal women, and to confirm its long-term safety and tolerability. Methods A 10-year, open, non-randomized, prospective study was conducted in 110 postmenopausal women; 59 women received tibolone 2.5 mg daily and 51 were entered into an untreated control group. After 10 years, 31 women in the tibolone group (53%) and 26 (51%) in the control group remained in the study. Results After 10 years, tibolone had significantly (p < 0.0001) increased the mean bone mineral density in the lumbar spine and femoral neck by 4.8% and 3.7%, respectively, compared with baseline. The corresponding changes in the control group were -8.5% and -8.9% (p < 0.0001 vs. baseline), respectively. The incidence and intensity of hot flushes were reduced in the tibolone group and there were improvements in vaginal cytology parameters. Tibolone was well tolerated. Conclusion Tibolone 2.5-mg daily maintains its beneficial effects on bone loss over 10 years, while remaining well tolerated.