Effects of two doses of tibolone on trabecular and cortical bone loss in early postmenopausal women: A two-year randomized, placebo-controlled study

B. Berning, C. V. Kuijk, J. W. Kuiper, H. J T Coelingh Bennink, P. M. Kicovic, B. C J M Fauser

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

The present randomized, double-blind, placebo controlled, 2-year study is the first to evaluate the effect of 1.25 and 2.5 mg tibolone daily oral administration on trabecular and cortical bone loss in early postmenopausal women. Ninety-four healthy, normal weight, nonsmoking women participated 1-3 years following spontaneous menopause. Twenty-three subjects were randomized to the placebo group, 36 to the 1.25 mg/day tibolone group, and 35 to the 2.5 mg/day tibolone group. Bone density was assessed at 6 month intervals. Spinal trabecular bone density (BD) was measured with quantitative computed tomography. Phalangeal cortical BD was measured by radiographic absorptiometry. The 2-year change vs, baseline in the placebo group for trabecular BD was -6.4% (95% confidence interval -8.1 to -4.7). Cortical BD did not change significantly. At 24 months both tibolone groups showed a statistically significantly higher trabecular [9.4% (6.6-12.2) for the 1.25 mg group and 14.7% (11.8-17.5%) for the 2.5 mg group] and phalangeal BD [4.4% (1.5-7.4) for the 1.25 mg group and 6.8% (3.8-9.8) for the 2.5 mg group] as compared to the placebo group. After 2 years of tibolone in both regimes, trabecular and phalangeal BD was significantly higher as compared to pretreatment values. At 24 months the 2.5 mg group showed a significantly higher trabecular (p < 0.001) but not phalangeal (p = 0.064) BD compared to the 1.25 mg group. Tibolone prevents early postmenopausal bone loss by inducing an increase in trabecular and phalangeal BD.

Original languageEnglish
Pages (from-to)395-399
Number of pages5
JournalBone
Volume19
Issue number4
DOIs
Publication statusPublished - Oct 1996

Cite this

Berning, B., Kuijk, C. V., Kuiper, J. W., Coelingh Bennink, H. J. T., Kicovic, P. M., & Fauser, B. C. J. M. (1996). Effects of two doses of tibolone on trabecular and cortical bone loss in early postmenopausal women: A two-year randomized, placebo-controlled study. Bone, 19(4), 395-399. https://doi.org/10.1016/S8756-3282(96)00219-0
Berning, B. ; Kuijk, C. V. ; Kuiper, J. W. ; Coelingh Bennink, H. J T ; Kicovic, P. M. ; Fauser, B. C J M. / Effects of two doses of tibolone on trabecular and cortical bone loss in early postmenopausal women : A two-year randomized, placebo-controlled study. In: Bone. 1996 ; Vol. 19, No. 4. pp. 395-399.
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title = "Effects of two doses of tibolone on trabecular and cortical bone loss in early postmenopausal women: A two-year randomized, placebo-controlled study",
abstract = "The present randomized, double-blind, placebo controlled, 2-year study is the first to evaluate the effect of 1.25 and 2.5 mg tibolone daily oral administration on trabecular and cortical bone loss in early postmenopausal women. Ninety-four healthy, normal weight, nonsmoking women participated 1-3 years following spontaneous menopause. Twenty-three subjects were randomized to the placebo group, 36 to the 1.25 mg/day tibolone group, and 35 to the 2.5 mg/day tibolone group. Bone density was assessed at 6 month intervals. Spinal trabecular bone density (BD) was measured with quantitative computed tomography. Phalangeal cortical BD was measured by radiographic absorptiometry. The 2-year change vs, baseline in the placebo group for trabecular BD was -6.4{\%} (95{\%} confidence interval -8.1 to -4.7). Cortical BD did not change significantly. At 24 months both tibolone groups showed a statistically significantly higher trabecular [9.4{\%} (6.6-12.2) for the 1.25 mg group and 14.7{\%} (11.8-17.5{\%}) for the 2.5 mg group] and phalangeal BD [4.4{\%} (1.5-7.4) for the 1.25 mg group and 6.8{\%} (3.8-9.8) for the 2.5 mg group] as compared to the placebo group. After 2 years of tibolone in both regimes, trabecular and phalangeal BD was significantly higher as compared to pretreatment values. At 24 months the 2.5 mg group showed a significantly higher trabecular (p < 0.001) but not phalangeal (p = 0.064) BD compared to the 1.25 mg group. Tibolone prevents early postmenopausal bone loss by inducing an increase in trabecular and phalangeal BD.",
author = "B. Berning and Kuijk, {C. V.} and Kuiper, {J. W.} and {Coelingh Bennink}, {H. J T} and Kicovic, {P. M.} and Fauser, {B. C J M}",
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Effects of two doses of tibolone on trabecular and cortical bone loss in early postmenopausal women : A two-year randomized, placebo-controlled study. / Berning, B.; Kuijk, C. V.; Kuiper, J. W.; Coelingh Bennink, H. J T; Kicovic, P. M.; Fauser, B. C J M.

In: Bone, Vol. 19, No. 4, 10.1996, p. 395-399.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Effects of two doses of tibolone on trabecular and cortical bone loss in early postmenopausal women

T2 - A two-year randomized, placebo-controlled study

AU - Berning, B.

AU - Kuijk, C. V.

AU - Kuiper, J. W.

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AU - Kicovic, P. M.

AU - Fauser, B. C J M

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N2 - The present randomized, double-blind, placebo controlled, 2-year study is the first to evaluate the effect of 1.25 and 2.5 mg tibolone daily oral administration on trabecular and cortical bone loss in early postmenopausal women. Ninety-four healthy, normal weight, nonsmoking women participated 1-3 years following spontaneous menopause. Twenty-three subjects were randomized to the placebo group, 36 to the 1.25 mg/day tibolone group, and 35 to the 2.5 mg/day tibolone group. Bone density was assessed at 6 month intervals. Spinal trabecular bone density (BD) was measured with quantitative computed tomography. Phalangeal cortical BD was measured by radiographic absorptiometry. The 2-year change vs, baseline in the placebo group for trabecular BD was -6.4% (95% confidence interval -8.1 to -4.7). Cortical BD did not change significantly. At 24 months both tibolone groups showed a statistically significantly higher trabecular [9.4% (6.6-12.2) for the 1.25 mg group and 14.7% (11.8-17.5%) for the 2.5 mg group] and phalangeal BD [4.4% (1.5-7.4) for the 1.25 mg group and 6.8% (3.8-9.8) for the 2.5 mg group] as compared to the placebo group. After 2 years of tibolone in both regimes, trabecular and phalangeal BD was significantly higher as compared to pretreatment values. At 24 months the 2.5 mg group showed a significantly higher trabecular (p < 0.001) but not phalangeal (p = 0.064) BD compared to the 1.25 mg group. Tibolone prevents early postmenopausal bone loss by inducing an increase in trabecular and phalangeal BD.

AB - The present randomized, double-blind, placebo controlled, 2-year study is the first to evaluate the effect of 1.25 and 2.5 mg tibolone daily oral administration on trabecular and cortical bone loss in early postmenopausal women. Ninety-four healthy, normal weight, nonsmoking women participated 1-3 years following spontaneous menopause. Twenty-three subjects were randomized to the placebo group, 36 to the 1.25 mg/day tibolone group, and 35 to the 2.5 mg/day tibolone group. Bone density was assessed at 6 month intervals. Spinal trabecular bone density (BD) was measured with quantitative computed tomography. Phalangeal cortical BD was measured by radiographic absorptiometry. The 2-year change vs, baseline in the placebo group for trabecular BD was -6.4% (95% confidence interval -8.1 to -4.7). Cortical BD did not change significantly. At 24 months both tibolone groups showed a statistically significantly higher trabecular [9.4% (6.6-12.2) for the 1.25 mg group and 14.7% (11.8-17.5%) for the 2.5 mg group] and phalangeal BD [4.4% (1.5-7.4) for the 1.25 mg group and 6.8% (3.8-9.8) for the 2.5 mg group] as compared to the placebo group. After 2 years of tibolone in both regimes, trabecular and phalangeal BD was significantly higher as compared to pretreatment values. At 24 months the 2.5 mg group showed a significantly higher trabecular (p < 0.001) but not phalangeal (p = 0.064) BD compared to the 1.25 mg group. Tibolone prevents early postmenopausal bone loss by inducing an increase in trabecular and phalangeal BD.

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