Vascular and Skeletal Protective Effects of Genistein in Postmenopausal Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 400
- 主要终点
- Efficacy:
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Concomitant disease
- •Smoke habit
结局指标
主要结局
Efficacy:
bone resorption/formation
bone mineral density
cardiovascular risk factors
Safety:
endometrial thickness
次要结局
- Efficacy:
- hot flushes reduction
- Safety:
- mammography
- vaginal cells maturation value