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Bone Mineral Density and Lipid Changes During 5 Years of Follow-up in a Study of Prevention of Breast Cancer with Toremifene in Healthy, High-risk Pre- and Post-menopausal Women

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Summary

A double-blind, randomised, placebo-controlled pilot study was initiated to evaluate the feasibility of chemoprevention with toremifene 60 mg/day in healthy women at high risk for breast cancer. Enrolment in the study was terminated earlier than planned because of slow patient accrual, although 13% of patients continued for 5 years. The revised efficacy outcomes were change in bone mineral density (BMD) from baseline at four skeletal sites, plus effects on serum lipids. In premenopausal women there was a trend for sustained increase in BMD during toremifene therapy after year 1 in lumbar spine. In postmenopausal women, toremifene had little or no effect on BMD trends. Levels of total and low-density lipoprotein (LDL) cholesterol were largely unchanged from baseline in premenopausal women treated with toremifene but were often slightly lower than in the placebo group during follow-up. Total and LDL cholesterol levels declined slightly from baseline in the postmenopausal women and were, at several points during the first 3 years, significantly lower than in the corresponding placebo group (p < 0.01). We conclude that: (a) assessment of toremifene 60 mg/day in chemoprevention will require further clinical trials; (b) toremifene 60 mg/day has no substantive negative effects on BMD in pre- or postmenopausal women and may exert a minor favourable influence (in particular, the effects of toremifene 60 mg/day on BMD in premenopausal women may make the drug an attractive alternative to tamoxifen 20 mg/day for that patient subset); (c) lipid effects of toremifene 60 mg/day are, at minimum, neutral and may be modestly favourable for reducing cardiovascular risk.

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Authors and Affiliations

  1. Department of Obstetrics and Gynaecology, Turku University Central Hospital, Turku, Finland

    R. Erkkola

  2. Orion Corporation Orion Pharma, Espoo, Finland

    L. Mattila, B. Toivola,  P. Korhonen & M. Mustonen

  3. The Royal Marsden Hospital, Breast Unit Downs Road, Sutton, UK

    T. Powles

  4. Osteoporosis Clinic, Oulu Deaconess Institute, Oulu, Finland

    J. Heikkinen

Authors
  1. R. Erkkola
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  2. L. Mattila
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  3. T. Powles
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  4. J. Heikkinen
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  5. B. Toivola
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  6. P. Korhonen
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  7. M. Mustonen
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Correspondence to M. Mustonen.

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Erkkola, R., Mattila, L., Powles, T. et al. Bone Mineral Density and Lipid Changes During 5 Years of Follow-up in a Study of Prevention of Breast Cancer with Toremifene in Healthy, High-risk Pre- and Post-menopausal Women. Breast Cancer Res Treat 93, 277–287 (2005). https://doi.org/10.1007/s10549-005-5701-x

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  • DOI: https://doi.org/10.1007/s10549-005-5701-x

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