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1303408 
Journal Article 
Ten years of treatment with tibolone 2.5 mg daily: effects on bone loss in postmenopausal women 
Rymer, J; Robinson, J; Fogelman, I 
2002 
Yes 
Climacteric
ISSN: 1369-7137
EISSN: 1473-0804 
5 
4 
390-398 
English 
12626219 
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.