NCT Number: NCT00355953
Vascular and Skeletal Protective Effects of Genistein in Postmenopausal Women
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.
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Notify MeKey information
Conditions
Age range
45 year–70 year
Sex eligibility
Female
Study type
Interventional
Phase
Phase 2 / Phase 3
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
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
Sponsors and collaborators
Lead sponsor
University of Messina
Other
Registry information
Important dates
- Study start
- 2003
- Study completion
- 2005
- First posted
- Jul 25, 2006
- Registry last updated
- Apr 22, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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