Menopause Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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|---|---|---|---|
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