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Vascular and Skeletal Protective Effects of Genistein in Postmenopausal Women

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00355953
Enrollment
400
Registered
2006-07-25
Start date
2003-01-31
Completion date
2005-06-30
Last updated
2008-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause, Osteopenia

Keywords

Post-Menopausal Women, Osteoporosis, Phytoestrogen, Genistein

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.

Interventions

DRUGGenistein

Sponsors

University of Messina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frame
endometrial thickness
Efficacy:
bone resorption/formation
bone mineral density
cardiovascular risk factors
Safety:

Secondary

MeasureTime frame
hot flushes reduction
Safety:
mammography
vaginal cells maturation value
Efficacy:

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026