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Effects of tibolone and raloxifene on bone mineral density in osteopenic postmenopausal women

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Abstract

Summary

A randomized trial was conducted in osteopenic postmenopausal women to compare the efficacy of tibolone versus raloxifene on BMD of the lumbar spine and hip. Tibolone increased lumbar spine and total hip BMD to a statistically significantly greater extent than raloxifene after two years of treatment.

Introduction

Both tibolone, a selective tissue estrogenic activity regulator (STEAR), and raloxifene, a selective estrogen receptor modulator (SERM), are known to prevent postmenopausal bone loss. However, no head-to-head studies to compare the efficacy on bone have been performed.

Methods

A double-blind, randomized trial was conducted in osteopenic postmenopausal women aged 60–79 years to compare the effects of tibolone 1.25 mg/day to raloxifene 60 mg/day on bone mineral density (BMD). Serum osteocalcin and serum type I collagen C-telopeptides were measured as biochemical markers of bone metabolism.

Results

Three hundred and eight subjects were allocated to treatment. Both treatments significantly increased lumbar spine BMD, however the increase was significantly larger after tibolone treatment than after raloxifene treatment (at year 1: 2.2% versus 1.2%, p < 0.01 and at year 2: 3.8% versus 2.1%, p < 0.001). After 2 years of treatment, the increase in total hip BMD in the tibolone group was significantly larger than in the raloxifene group (p < 0.05). Both treatments significantly reduced type I collagen C-telopeptides and osteocalcin levels when compared to baseline.

Conclusions

Tibolone 1.25 mg/day for 2 years prevents postmenopausal bone loss in older women and results in a larger increase of BMD both at the lumbar spine and hip than raloxifene.

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Acknowledgements

The authors would like to thank Ellemiek von Mauw (Global Clinical Development, Organon, Oss) and Sabine Braat (Biometrics Department, Organon, Oss) for their contributions to the execution, statistical analysis and reporting of this study. The editorial contribution of Jane Irons (JSI Communications) to this manuscript is also acknowledged.

Conflicts of interest

P. Delmas has consulted for and received speaker fees from Organon. E. Nijland was an employee of Organon at the time of the study. S. Davis has been an investigator for Organon and has received honoraria for lectures from Organon. S. Adami and J. Hensen report no relevant conflicts of interest.

Funding source

This study was funded by NV Organon, Oss, The Netherlands.

Manufacturer names

Tibolone (Livial®): NV Organon

Raloxifene (Evista®): Eli Lilly

Author information

Authors and Affiliations

  1. INSERM Research Unit 831 and University of Lyon, Lyon, France

    P. D. Delmas

  2. Monash Medical School, Prahran, Australia

    S. R. Davis

  3. University of Erlangen, Erlangen, Germany

    J. Hensen

  4. University of Verona, Valeggio sul Mincio, VR, Italy

    S. Adami

  5. Global Clinical Development, NV Organon, Oss, The Netherlands

    S. van Os

  6. Rugpoli Twente, Delden, The Netherlands

    E. A. Nijland

  7. INSERM Research Unit 831, Hôpital E. Herriot, Pavillon F, Lyon, 69437, Cedex 03, France

    P. D. Delmas

Authors
  1. P. D. Delmas
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  2. S. R. Davis
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  3. J. Hensen
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  4. S. Adami
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  6. E. A. Nijland
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Corresponding author

Correspondence to P. D. Delmas.

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Delmas, P.D., Davis, S.R., Hensen, J. et al. Effects of tibolone and raloxifene on bone mineral density in osteopenic postmenopausal women. Osteoporos Int 19, 1153–1160 (2008). https://doi.org/10.1007/s00198-007-0545-3

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  • DOI: https://doi.org/10.1007/s00198-007-0545-3

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