NCT00899288终止3 期
Investigating the Chemical Properties of Fingernails to Determine the Efficacy of Nail Structure for Evaluating Bone Fragility
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 60
- 主要终点
- Determination of bone health using fingernail assessments at baseline and 6 months
研究概览
简要总结
RATIONALE: Studying samples of fingernails in the laboratory from patients with breast cancer may help in evaluating bone health in postmenopausal women undergoing hormone therapy for breast cancer.
PURPOSE: This laboratory study is examining fingernails as a way of evaluating bone health in postmenopausal women with breast cancer undergoing hormone therapy on clinical trial IBCSG-1-98.
详细描述
OBJECTIVES:
Primary
- Compare the effects of tamoxifen vs letrozole on the chemical properties of fingernails by Raman spectroscopy in postmenopausal women with breast cancer undergoing adjuvant hormonal therapy on protocol IBCSG-1-98.
- Determine the efficacy of nail structure for evaluating bone fragility.
Secondary
- Compare fingernail assessments in patients who have had a bone fracture vs those who have not.
- Determine the natural variation in chemical (Raman spectroscopy) properties of 2 fingernails sourced at 1 appointment from the same donor.
- Evaluate the effect of further drug treatment (after 6 months) on the chemical properties of fingernails.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Determination of bone health using fingernail assessments at baseline and 6 months
时间窗: At baseline and 6 months after inclusion in the trial
次要结局
未报告次要终点
研究者
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