|Reference : Tibolone increases bone mineral density but also relapse in breast cancer survivors: ...|
|Scientific journals : Article|
|Human health sciences : Reproductive medicine (gynecology, andrology, obstetrics)|
|Tibolone increases bone mineral density but also relapse in breast cancer survivors: LIBERATE Trial Bone Sub-study.|
|Bundred, N. J. [ > > ]|
|Kenemans, P. [ > > ]|
|Yip, C. H. [ > > ]|
|Beckmann, M. W. [ > > ]|
|Foidart, Jean-Michel [Université de Liège - ULg > Département des sciences cliniques > Gynécologie - Obstétrique >]|
|Sismondi, P. [ > > ]|
|Von Schoultz, B. [ > > ]|
|Vassiliopoulou-Sellin, R. [ > > ]|
|El Galta, R. [ > > ]|
|Van Lieshout, E. [ > > ]|
|Mol-Arts, M. [ > > ]|
|Planellas, J. [ > > ]|
|Kubista, E. [ > > ]|
|Breast Cancer Research [=BCR]|
|Yes (verified by ORBi)|
|[en] INTRODUCTION: Livial Intervention Following Breast Cancer; Efficacy, Recurrence and Tolerability Endpoints (LIBERATE - ClinicalTrials.gov number NCT00408863), a randomized, placebo controlled, double-blind trial which demonstrated that tibolone (Livial), a tissue selective hormone replacement therapy (HRT) increased breast cancer (BC) recurrence HR 1.40 (95% CI 1.14-1.70; p=0.001) entered a subgroup of women into a study of Bone Mineral Density (BMD).
Women with surgically excised primary BC (T1-3, N0-2, M0) within the last 5 years complaining of vasomotor symptoms, were assigned to tibolone 2.5mg daily or placebo treatment for a maximum of 5 years. The BMD sub-study enrolled 763 patients utilizing dual-energy X-ray absorptiometry (DXA) scanning at baseline and at 2 years.
In the bone sub-study 699 out of 763 women were eligible (345 allocated to tibolone and 354 to placebo) after undergoing DXA scans, 300 (43%) women had normal BMD, 317 (45%) osteopenia and 82 (11.7%) osteoporosis. Low body mass index (<0.001), Asian race (p<0.001) and late age at menarche (p<0.04) predicted for low bone mass at baseline. Tibolone increased BMD by 3.2% at the lumbar spine and 2.9% at the hip compared to placebo (both p<0.001). The majority of fractures (55%) occurred in osteopaenic patients. Women with normal BMD had increased recurrence on tibolone 15.6% (22/141) compared to placebo 6.9% (11/159) p=0.016, whereas no increased BC recurrence was seen in women with low BMD; 7.4% (15/204) on tibolone versus (6.7% (13/195) on placebo.
Tibolone is contraindicated after BC treatment as it increases BMD and BC recurrence. Risk of BC recurrence was elevated in BC women with normal BMD (compared to low) who took tibolone.
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