Safety, Efficacy, and Optimal Dosage of Soy Isoflavones to Prevent Osteoporosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 403
- 试验地点
- 6
- 主要终点
- Bone mineral density
研究概览
简要总结
The purpose of this study is to determine whether soy isoflavone supplementation is safe and effective to prevent bone loss in postmenopausal women.
详细描述
Over-the-counter soy isoflavone supplement usage is becoming common among postmenopausal women. However, there is no documented scientific evidence of its long-term safety and efficacy in preventing osteoporosis. Our primary goal is to determine the safety, efficacy, and optimal dosage of isoflavone supplementation to reduce bone loss in postmenopausal women. The multi-state, multi-institutional design ensures that the study results are representative of postmenopausal women in the U.S. population. Confirming the skeletal benefits of soy isoflavones could translate into reduced healthcare costs related to osteoporosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Must be able to swallow the pills
- •No menses for 12 months
- •Blood follicle stimulating hormone great than 30 IU/mL
- •Lumbar spine bone mineral density t-score equal to or greater than -1.5
排除标准
- •Strict vegetarians
- •Current or recent smokers (within last five years)
- •Abnormal screening mammogram, Pap smear and blood chemistries
- •Clinical diagnosis of osteoporosis, spine and/or hip fracture, cancer, liver, kidney, gallbladder and heart disease
- •Clinical diagnosis of psychiatric disorder
- •Any allergic reactions to soy products
- •Current treatment with bisphosphonates, calcitonin, fluoride, corticosteroids, tamoxifen, raloxifene, HRT, premarin, farestron and letrozole
- •Current usage of black cohosh, blue cohosh, dong quai, Caltrate 600+Soy, Estroven, ginseng, Healthy Women, Natural Estrogen, Opti-Soy, PhytoFem, Probalance, Promensil, Remifemin, Rimostil and Trinovin
结局指标
主要结局
Bone mineral density
时间窗: One year and two years
次要结局
- Blood biochemical bone markers (osteocalcin, bone-specific alkaline phosphatase, cross-linked N-telopeptides of type 1 collagen)(One year and two years)
研究者
William Wong
Professor
Baylor College of Medicine