Vascular and Skeletal Protective Effects of Genistein in Postmenopausal Women

Study Overview
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Brief Summary
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The present research program is proposed deepening some pharmacological effects of the genistein therapy in order to individualize alternative treatments to the conventional hormonal replacement therapy useful to reduce the cardiovascular morbidity and mortality and the osteoporotic consequences in postmenopausal women.

Detailed Description
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Genistein is a phytoestrogen of the isoflavone family which has been shown to have beneficial effects on endothelial function and bone metabolism. On the basis of the so far obtained results, aim of our research was to investigate for a two years period the effects of genistein on cardiovascular risk factors, endothelial function and oxidative stress markers, bone metabolism and finally clarify pathophysiology mechanisms (by dosage of cytokines and endothelial markers) by which this molecule could interfere on atherosclerosis and bone mass loss progression. Particularly, and in extreme synthesis the following parameters have been studied during the treatment: inflammation markers as fibrinogen lipid profile - total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, lipoprotein(a)- endothelial function markers as VCAM-1 and ICAM-1 oxidative stress by the evaluation of the F(2)-isoprostane cytokines as IL-6, OPG, RANK and RANKL bone mineral density, by DEXA, at lumbar spine and femoral neck Bone turnover markers as B-ALP, PYR, D-PYR PAP-test, transvaginal uterine ecography and mammography.

Conditions
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Menopause, Osteopenia

Intervention / Treatment
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* Drug: Genistein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least one year of menopause No use of hormone replacement therapy Bone mineral density T-score at the femoral neck minor than one S.D. Exclusion Criteria: Concomitant disease Smoke habit

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Genistein|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: |  |  | 
| bone resorption/formation |  |  | 
| bone mineral density |  |  | 
| cardiovascular risk factors |  |  | 
| Safety: |  |  | 
| endometrial thickness |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: |  |  | 
| hot flushes reduction |  |  | 
| Safety: |  |  | 
| mammography |  |  | 
| vaginal cells maturation value |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-Menopausal Women, Osteoporosis, Phytoestrogen, Genistein