Vascular and Skeletal Protective Effects of Genistein in Postmenopausal Women

• Sponsor: University of Messina (Other)
• Overall Status: Completed
• CT.gov ID: NCT00355953
• Collaborator: (none)
• Enrollment: 400
• Duration (Months): 29

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Menopause; Osteopenia	Drug: Genistein	Phase 2/Phase 3

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2003
• Study Completion Date: Jun 1, 2005

Outcome Measures

Primary Outcome Measures

1. Efficacy: []

2. bone resorption/formation []

3. bone mineral density []

4. cardiovascular risk factors []

5. Safety: []

6. endometrial thickness []

Secondary Outcome Measures

1. Efficacy: []

2. hot flushes reduction []

3. Safety: []

4. mammography []

5. vaginal cells maturation value []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Messina

Investigators

• Study Director: Francesco Squadrito, MD, University of Messina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00355953
• Other Study ID Numbers: 2002067398
• First Posted: Jul 25, 2006
• Last Update Posted: Apr 22, 2008
• Last Verified: Apr 1, 2008

• Keywords provided by , ,: Post-Menopausal Women; Osteoporosis; Phytoestrogen; Genistein
• Additional relevant MeSH terms: Bone Diseases, Metabolic; Genistein

Study Results

No Results Posted as of Apr 22, 2008