Vascular and Skeletal Protective Effects of Genistein in Postmenopausal Women

April 18, 2008 updated by: University of Messina
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

400

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy:
Safety:
bone mineral density
bone resorption/formation
cardiovascular risk factors
endometrial thickness

Secondary Outcome Measures

Outcome Measure
Efficacy:
Safety:
hot flushes reduction
mammography
vaginal cells maturation value

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Messina

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

July 24, 2006

First Submitted That Met QC Criteria

July 24, 2006

First Posted (Estimate)

July 25, 2006

Study Record Updates

Last Update Posted (Estimate)

April 22, 2008

Last Update Submitted That Met QC Criteria

April 18, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2002067398

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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