Vascular and Skeletal Protective Effects of Genistein in Postmenopausal Women
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Messina
- Enrollment
- 400
- Primary Endpoint
- Efficacy:
Study Overview
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:
- inflammation markers as fibrinogen
- lipid profile - total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, lipoprotein(a)-
- endothelial function markers as VCAM-1 and ICAM-1
- oxidative stress by the evaluation of the F(2)-isoprostane
- cytokines as IL-6, OPG, RANK and RANKL
- bone mineral density, by DEXA, at lumbar spine and femoral neck
- Bone turnover markers as B-ALP, PYR, D-PYR
- PAP-test, transvaginal uterine ecography and mammography.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 45 Years to 70 Years (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Efficacy:
bone resorption/formation
bone mineral density
cardiovascular risk factors
Safety:
endometrial thickness
Secondary Outcomes
- Efficacy:
- hot flushes reduction
- Safety:
- mammography
- vaginal cells maturation value