Osteoporosis International

, Volume 13, Issue 3, pp 241–248

Randomized, Double-masked, 2-year Comparison of Tibolone with 17β-Estradiol and Norethindrone Acetate in Preventing Postmenopausal Bone Loss

  • C. Roux
  • C. Pelissier
  • J. Fechtenbaum
  • S. Loiseau-Peres
  • C. L. Benhamou
Original Article

DOI: 10.1007/s001980200021

Cite this article as:
Roux, C., Pelissier, C., Fechtenbaum, J. et al. Osteoporos Int (2002) 13: 241. doi:10.1007/s001980200021

Abstract

In this 2-year, randomized study, we compared the efficacy and tolerability of tibolone 2.5 mg (n= 75), tibolone 1.25 mg (n= 76) and estradiol 2 mg plus norethindrone acetate 1 mg (E2/NETA; n= 74) for preventing bone loss in postmenopausal women. Bone mineral density (BMD), measured by dual-energy X-ray absorptiometry, and bone remodeling markers were assessed every 6 months. Side-effects were assessed quarterly. After 24 months, the mean increase (± SD) in lumbar spine BMD from baseline was 3.6%± 2.9%, 1.9%± 3.5% and 6.8%± 4.5% in the tibolone 2.5 mg, tibolone 1.25 mg and E2/NETA groups, respectively. All pairwise differences were significant. The proportion of responders (women with a change from baseline in lumbar spine BMD of ≥−2% after 2 years) was 95.7%, 89.0% and 98.5% with tibolone 2.5 mg, tibolone 1.25 mg and E2/NETA, respectively. Similar results were obtained for femoral BMD, although the difference between tibolone 2.5 mg and E2/NETA was not significant at 24 months. Decreases in bone remodeling markers were similar in the three groups. Vaginal bleeding was more common in the E2/NETA group (33.8%) than with tibolone 2.5 mg (12.0%) or tibolone 1.25 mg (9.2%), as was breast pain (23.0%, 2.7% and 2.6%, respectively). Each treatment effectively prevented bone loss. Overall, tolerability of tibolone was better than with E2/NETA, because of less frequent vaginal bleeding and breast pain. This may promote long-term adherence.

Key words:Bleeding – Bone mineral density – Breast pain – Hormone replacement – Osteoporosis – Tibolone 

Copyright information

© International Osteoporosis Foundation and National Osteoporosis Foundation 2002

Authors and Affiliations

  • C. Roux
    • 1
  • C. Pelissier
    • 2
  • J. Fechtenbaum
    • 1
  • S. Loiseau-Peres
    • 3
  • C. L. Benhamou
    • 3
  1. 1.Centre d’Evaluation des Maladies Osseuses, De´partement de Rhumatologie, Ho^pital Cochin, Universite´ Rene´ Descartes, Paris, FranceFR
  2. 2.Service de Gyne´cologie, Ho^pital Hotel-Dieu, Paris, France;FR
  3. 3.Equipe INSERM ERIT-M0101, Service de Rhumatologie, Ho^pital Porte Madeleine, Orle´ans, FranceFR

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