The effect of tibolone on bone mineral density in postmenopausal women with osteopenia or osteoporosis - 8 years follow-up

Objectives: This longitudinal observational study evaluated the effect of 8 years of uninterrupted treatment of fibolone on bone mineral density (BMD) in postmenopausal women with significant osteopenia or osteoporosis. Material and methods: Subjects were 66 postmenopausal women (29 with moderate or severe osteopenia and 37 with osteoporosis) who took tibolone (2.5 mg nocte) uninterruptedly for over 8 years and who attended for annual BMD assessments. Their mean age was 66.7 (0.86) years (range 50-86 years). BMD measurements at the lumbar spine and proximal femur were performed annually by dual-energy X-ray absorptiometry (DEXA). Results: During the 8 years of treatment with fibolone there was a significant increase in BMD at the spine (P < 0.001) and at the hip (P < 0.001). Women who did not have previous oestrogen therapy had significantly greater response to fibolone than those who had previous treatment with conventional hormone replacement therapy (HRT). Conclusion: This long-term observational study provides evidence of the effectiveness of fibolone in postmenopausal women with moderate/severe osteopenia and osteoporosis in terms of a significant increase in BMD. (C) 2003 Elsevier Ireland Ltd. All rights reserved.