Article (Scientific journals)
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. et al.
2012In Breast Cancer Research, 14 (1), p. 13
Peer Reviewed verified by ORBi
 

Files


Full Text
Bundred Nj bcr 2012.pdf
Publisher postprint (253.06 kB)
Download

All documents in ORBi are protected by a user license.

Send to



Details



Abstract :
[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). METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Disciplines :
Reproductive medicine (gynecology, andrology, obstetrics)
Author, co-author :
Bundred, N. J.
Kenemans, P.
Yip, C. H.
Beckmann, M. W.
Foidart, Jean-Michel ;  Université de Liège - ULiège > 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.
More authors (3 more) Less
Language :
English
Title :
Tibolone increases bone mineral density but also relapse in breast cancer survivors: LIBERATE Trial Bone Sub-study.
Publication date :
2012
Journal title :
Breast Cancer Research
ISSN :
1465-5411
eISSN :
1465-542X
Publisher :
BioMed Central, London, United Kingdom
Volume :
14
Issue :
1
Pages :
R13
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 25 January 2012

Statistics


Number of views
110 (0 by ULiège)
Number of downloads
366 (0 by ULiège)

Scopus citations®
 
27
Scopus citations®
without self-citations
27
OpenCitations
 
30

Bibliography


Similar publications



Contact ORBi