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


CONCLUSIONS
Tibolone 2.5 mg daily maintains its beneficial effects on bone loss over 10 years, while remaining well tolerated.
Rymer
J
J
Guy's, King's and St. Thomas' School of Medicine, London, UK.
Robinson
J
J
Fogelman
I
I
D000469:Alkaline Phosphatase / Q000097:blood / Q000187:drug effects; D015519:Bone Density / Q000187:drug effects*; D002118:Calcium / Q000652:urine; D016022:Case-Control Studies; D003404:Creatinine / Q000652:urine; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D020847:Estrogen Receptor Modulators / Q000008:administration & dosage*; D015914:Estrogen Replacement Therapy; D005260:Female; D005272:Femur Neck / Q000187:drug effects; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D008159:Lumbar Vertebrae / Q000187:drug effects; D008875:Middle Aged; D009652:Norpregnenes / Q000008:administration & dosage*; D015663:Osteoporosis, Postmenopausal / Q000517:prevention & control*; D011446:Prospective Studies; D013997:Time Factors; D006113:United Kingdom; D014621:Vagina / Q000187:drug effects
D020847:Estrogen Receptor Modulators; D009652:Norpregnenes; D003404:Creatinine; D000469:Alkaline Phosphatase; C027385:tibolone; D002118:Calcium