Vascular and Skeletal Protective Effects of Genistein in Postmenopausal Women

Phase 2

Completed

• Conditions: Menopause; Osteopenia

• Registration Number: NCT00355953
• Lead Sponsor: University of Messina

Brief Summary

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

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:

1. inflammation markers as fibrinogen

2. lipid profile - total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, lipoprotein(a)-

3. endothelial function markers as VCAM-1 and ICAM-1

4. oxidative stress by the evaluation of the F(2)-isoprostane

5. cytokines as IL-6, OPG, RANK and RANKL

6. bone mineral density, by DEXA, at lumbar spine and femoral neck

7. Bone turnover markers as B-ALP, PYR, D-PYR

8. PAP-test, transvaginal uterine ecography and mammography.

Study Timeline

• Study Start: 2003-01
• Study Completion: 2005-06
• Study First Submitted: 2006-07-24
• Study First Submitted QC: 2006-07-24
• Study First Posted: 2006-07-25
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-18
• Last Update Posted: 2008-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy:
bone resorption/formation
bone mineral density
cardiovascular risk factors
Safety:
endometrial thickness

Secondary Outcome Measures

Name	Time	Method
Efficacy:
hot flushes reduction
Safety:
mammography
vaginal cells maturation value