NCT00355953

Vascular and Skeletal Protective Effects of Genistein in Postmenopausal Women

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 400 (planned)
• Sponsor: University of Messina · Academic / Other
• Sex: Female
• Age: 45 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Menopause
• Osteopenia

Interventions

Type	Name	Description
DRUG	Genistein

Timeline

• Start date: 2003-01-01
• Completion: 2005-06-01
• First posted: 2006-07-25
• Last updated: 2008-04-22