Vascular and Skeletal Protective Effects of Genistein in Postmenopausal Women

NCT ID: NCT00355953

Last Updated: 2008-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2005-06-30

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.

Conditions

Menopause; Osteopenia

Keywords

Post-Menopausal Women; Osteoporosis; Phytoestrogen; Genistein

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Genistein

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Messina

OTHER

Sponsor Role: lead

Principal Investigators

Francesco Squadrito, MD

Role: STUDY_DIRECTOR

University of Messina

References

Marini H, Minutoli L, Polito F, Bitto A, Altavilla D, Atteritano M, Gaudio A, Mazzaferro S, Frisina A, Frisina N, Lubrano C, Bonaiuto M, D'Anna R, Cannata ML, Corrado F, Adamo EB, Wilson S, Squadrito F. Effects of the phytoestrogen genistein on bone metabolism in osteopenic postmenopausal women: a randomized trial. Ann Intern Med. 2007 Jun 19;146(12):839-47. doi: 10.7326/0003-4819-146-12-200706190-00005.

Reference Type: DERIVED

PMID: 17577003 (View on PubMed)

Other Identifiers

2002067398

Identifier Type: -

Identifier Source: org_study_id