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Antiosteoporotic Activity of Genistein Aglycone in Postmenopausal Women: Evidence from a Post-Hoc Analysis of a Multicenter Randomized Controlled Trial

Genistein has a preventive role against bone mass loss during menopause. However, experimental data in animal models of osteoporosis suggest an anti-osteoporotic potential for this isoflavone. We performed a post-hoc analysis of a previously published trial investigating the effects of genistein in...

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Autores principales: Arcoraci, Vincenzo, Atteritano, Marco, Squadrito, Francesco, D’Anna, Rosario, Marini, Herbert, Santoro, Domenico, Minutoli, Letteria, Messina, Sonia, Altavilla, Domenica, Bitto, Alessandra
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5331610/
https://www.ncbi.nlm.nih.gov/pubmed/28241420
http://dx.doi.org/10.3390/nu9020179
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author Arcoraci, Vincenzo
Atteritano, Marco
Squadrito, Francesco
D’Anna, Rosario
Marini, Herbert
Santoro, Domenico
Minutoli, Letteria
Messina, Sonia
Altavilla, Domenica
Bitto, Alessandra
author_facet Arcoraci, Vincenzo
Atteritano, Marco
Squadrito, Francesco
D’Anna, Rosario
Marini, Herbert
Santoro, Domenico
Minutoli, Letteria
Messina, Sonia
Altavilla, Domenica
Bitto, Alessandra
author_sort Arcoraci, Vincenzo
collection PubMed
description Genistein has a preventive role against bone mass loss during menopause. However, experimental data in animal models of osteoporosis suggest an anti-osteoporotic potential for this isoflavone. We performed a post-hoc analysis of a previously published trial investigating the effects of genistein in postmenopausal women with low bone mineral density. The parent study was a randomized, double-blind, placebo-controlled trial involving postmenopausal women with a femoral neck (FN) density <0.795 g/cm(2). A cohort of the enrolled women was, in fact, identified at the baseline as osteoporotic (n = 121) on the basis of their T-score and analyzed thereafter for the 24 months’ treatment with either 1000 mg of calcium and 800 IU vitamin D3 (placebo; n = 59); or calcium, vitamin D3, and Genistein aglycone (54 mg/day; genistein; n = 62). According to the femoral neck T-scores, 31.3% of the genistein and 30.9% of the placebo recipients were osteoporotic at baseline. In the placebo and genistein groups, the 10-year hip fracture probability risk assessed by Fracture Risk Assessment tool (FRAX) was 4.1 ± 1.9 (SD) and 4.2 ± 2.1 (SD), respectively. Mean bone mineral density (BMD) at the femoral neck increased from 0.62 g/cm(2) at baseline to 0.68 g/cm(2) at 1 year and 0.70 g/cm(2) at 2 years in genistein recipients, and decreased from 0.61 g/cm(2) at baseline to 0.60 g/cm(2) at 1 year and 0.57 g/cm(2) at 2 years in placebo recipients. At the end of the study only 18 postmenopausal women had osteoporosis in the genistein group with a prevalence of 12%, whereas in the placebo group the number of postmenopausal women with osteoporosis was unchanged, after 24 months. This post-hoc analysis is a proof-of concept study suggesting that genistein may be useful not only in postmenopausal osteopenia but also in osteoporosis. However, this proof-of concept study needs to be confirmed by a large, well designed, and appropriately focused randomized clinical trial in a population at high risk of fractures.
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spelling pubmed-53316102017-03-13 Antiosteoporotic Activity of Genistein Aglycone in Postmenopausal Women: Evidence from a Post-Hoc Analysis of a Multicenter Randomized Controlled Trial Arcoraci, Vincenzo Atteritano, Marco Squadrito, Francesco D’Anna, Rosario Marini, Herbert Santoro, Domenico Minutoli, Letteria Messina, Sonia Altavilla, Domenica Bitto, Alessandra Nutrients Article Genistein has a preventive role against bone mass loss during menopause. However, experimental data in animal models of osteoporosis suggest an anti-osteoporotic potential for this isoflavone. We performed a post-hoc analysis of a previously published trial investigating the effects of genistein in postmenopausal women with low bone mineral density. The parent study was a randomized, double-blind, placebo-controlled trial involving postmenopausal women with a femoral neck (FN) density <0.795 g/cm(2). A cohort of the enrolled women was, in fact, identified at the baseline as osteoporotic (n = 121) on the basis of their T-score and analyzed thereafter for the 24 months’ treatment with either 1000 mg of calcium and 800 IU vitamin D3 (placebo; n = 59); or calcium, vitamin D3, and Genistein aglycone (54 mg/day; genistein; n = 62). According to the femoral neck T-scores, 31.3% of the genistein and 30.9% of the placebo recipients were osteoporotic at baseline. In the placebo and genistein groups, the 10-year hip fracture probability risk assessed by Fracture Risk Assessment tool (FRAX) was 4.1 ± 1.9 (SD) and 4.2 ± 2.1 (SD), respectively. Mean bone mineral density (BMD) at the femoral neck increased from 0.62 g/cm(2) at baseline to 0.68 g/cm(2) at 1 year and 0.70 g/cm(2) at 2 years in genistein recipients, and decreased from 0.61 g/cm(2) at baseline to 0.60 g/cm(2) at 1 year and 0.57 g/cm(2) at 2 years in placebo recipients. At the end of the study only 18 postmenopausal women had osteoporosis in the genistein group with a prevalence of 12%, whereas in the placebo group the number of postmenopausal women with osteoporosis was unchanged, after 24 months. This post-hoc analysis is a proof-of concept study suggesting that genistein may be useful not only in postmenopausal osteopenia but also in osteoporosis. However, this proof-of concept study needs to be confirmed by a large, well designed, and appropriately focused randomized clinical trial in a population at high risk of fractures. MDPI 2017-02-22 /pmc/articles/PMC5331610/ /pubmed/28241420 http://dx.doi.org/10.3390/nu9020179 Text en © 2017 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Arcoraci, Vincenzo
Atteritano, Marco
Squadrito, Francesco
D’Anna, Rosario
Marini, Herbert
Santoro, Domenico
Minutoli, Letteria
Messina, Sonia
Altavilla, Domenica
Bitto, Alessandra
Antiosteoporotic Activity of Genistein Aglycone in Postmenopausal Women: Evidence from a Post-Hoc Analysis of a Multicenter Randomized Controlled Trial
title Antiosteoporotic Activity of Genistein Aglycone in Postmenopausal Women: Evidence from a Post-Hoc Analysis of a Multicenter Randomized Controlled Trial
title_full Antiosteoporotic Activity of Genistein Aglycone in Postmenopausal Women: Evidence from a Post-Hoc Analysis of a Multicenter Randomized Controlled Trial
title_fullStr Antiosteoporotic Activity of Genistein Aglycone in Postmenopausal Women: Evidence from a Post-Hoc Analysis of a Multicenter Randomized Controlled Trial
title_full_unstemmed Antiosteoporotic Activity of Genistein Aglycone in Postmenopausal Women: Evidence from a Post-Hoc Analysis of a Multicenter Randomized Controlled Trial
title_short Antiosteoporotic Activity of Genistein Aglycone in Postmenopausal Women: Evidence from a Post-Hoc Analysis of a Multicenter Randomized Controlled Trial
title_sort antiosteoporotic activity of genistein aglycone in postmenopausal women: evidence from a post-hoc analysis of a multicenter randomized controlled trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5331610/
https://www.ncbi.nlm.nih.gov/pubmed/28241420
http://dx.doi.org/10.3390/nu9020179
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