title: Antiosteoporotic Activity of Genistein Aglycone in Postmenopausal Women: Evidence from a Post-Hoc Analysis of a Multicenter Randomized Controlled Trial.
abstract: 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/cm². 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/cm² at baseline to 0.68 g/cm² at 1 year and 0.70 g/cm² at 2 years in genistein recipients, and decreased from 0.61 g/cm² at baseline to 0.60 g/cm² at 1 year and 0.57 g/cm² 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.
authors.affiliation: Department of Clinical and Experimental Medicine, University of Messina, 98100 Messina, Italy. varcoraci@unime.it.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Arcoraci
authors.affiliation: Department of Clinical and Experimental Medicine, University of Messina, 98100 Messina, Italy. matteritano@unime.it.
authors.forename: Marco
authors.initials: M
authors.lastname: Atteritano
authors.affiliation: Department of Clinical and Experimental Medicine, University of Messina, 98100 Messina, Italy. fsquadrito@unime.it.
authors.forename: Francesco
authors.initials: F
authors.lastname: Squadrito
authors.affiliation: Department of Neurosciences and Nemo Sud Clinical Center, University of Messina, 98100 Messina, Italy. rdannna@unime.it.
authors.forename: Rosario
authors.initials: R
authors.lastname: D'Anna
authors.affiliation: Department of Clinical and Experimental Medicine, University of Messina, 98100 Messina, Italy. hrmarini@unime.it.
authors.forename: Herbert
authors.initials: H
authors.lastname: Marini
authors.affiliation: Department of Clinical and Experimental Medicine, University of Messina, 98100 Messina, Italy. santisi@hotmail.com.
authors.forename: Domenico
authors.initials: D
authors.lastname: Santoro
authors.affiliation: Department of Clinical and Experimental Medicine, University of Messina, 98100 Messina, Italy. lminutoli@unime.it.
authors.forename: Letteria
authors.initials: L
authors.lastname: Minutoli
authors.affiliation: Department of Neurosciences and Nemo Sud Clinical Center, University of Messina, 98100 Messina, Italy. smessina@unime.it.
authors.forename: Sonia
authors.initials: S
authors.lastname: Messina
authors.affiliation: Department of Paediatric, Gynaecological, Microbiological and Biomedical Sciences, University of Messina, 98100 Messina, Italy. daltavilla@unime.it.
authors.forename: Domenica
authors.initials: D
authors.lastname: Altavilla
authors.affiliation: Department of Clinical and Experimental Medicine, University of Messina, 98100 Messina, Italy. abitto@unime.it.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Bitto
mesh_terms: D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents; D002136:Calcium, Dietary / Q000627:therapeutic use; D002762:Cholecalciferol / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D005272:Femur Neck; D019833:Genistein / Q000627:therapeutic use*; D006620:Hip Fractures / Q000453:epidemiology / Q000517:prevention & control; D006801:Humans; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D048789:Phytoestrogens; D010919:Placebos; D017698:Postmenopause; D012306:Risk; D018570:Risk Assessment
chemical_list: D050071:Bone Density Conservation Agents; D002136:Calcium, Dietary; D048789:Phytoestrogens; D010919:Placebos; D002762:Cholecalciferol; D019833:Genistein
keywords: bone mineral density; genistein; postemenopausal osteoporosis