Vascular and Skeletal Protective Effects of Genistein in Postmenopausal Women

Menopause Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355953
• Other study ID #: 2002067398
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 24, 2006
• Last updated: April 18, 2008
• Start date: January 2003
• Est. completion date: June 2005

Study information

• Verified date: April 2008
• Source: University of Messina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menopause
• Osteopenia

Intervention

Drug:
• Genistein

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Messina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy:
Primary	bone resorption/formation
Primary	bone mineral density
Primary	cardiovascular risk factors
Primary	Safety:
Primary	endometrial thickness
Secondary	Efficacy:
Secondary	hot flushes reduction
Secondary	Safety:
Secondary	mammography
Secondary	vaginal cells maturation value