Investigating the Chemical Properties of Fingernails to Determine the Efficacy of Nail Structure for Evaluating Bone Fragility
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
- •DISEASE CHARACTERISTICS:
- •Enrolled on protocol IBCSG-1-98
- •Currently receiving (i.e., have not yet completed) 5 years of treatment with tamoxifen or letrozole and expected to receive ≥ 6 months of additional treatment on protocol IBCSG-1-98
- •No recurrent breast cancer or second primary cancer
- •No known bone disease (including osteomalacia or osteogenesis imperfecta)
- •Hormone receptor status
- •Estrogen and/or progesterone receptor positive tumor
- •PATIENT CHARACTERISTICS:
- •Postmenopausal
- •No uncontrolled thyroid or parathyroid disease, Cushing's disease, or other pituitary diseases
- •No malabsorption syndrome or clinically relevant vitamin D deficiency
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 1 year since prior and no concurrent anticonvulsants
- •More than 6 months since prior and no concurrent corticosteroids at doses > the equivalent of 5 mg/day of prednisone for > 2 weeks total
- •No prior or concurrent sodium fluoride at daily doses ≥ 5 mg/day for > 1 month
- •More than 12 months since prior and no concurrent anabolic steroids
- •More than 6 months since any prior drug for the prevention of osteoporosis (excluding calcium or cholecalciferol [vitamin D])
- •Concurrent warfarin allowed provided duration of treatment is no more than 4 weeks
排除标准
- 未提供
研究组 & 干预措施
tamoxifen and no bone fracture
Patients randomized to Arm A of Study BIG 1-98 (tamoxifen for 5 years) who have not had a bone fracture.
干预措施: spectroscopy (Procedure)
Letrozole and no bone fracture
Patients randomized to Arm B of Study BIG 1-98 (letrozole for 5 years) who have not had a bone fracture.
干预措施: spectroscopy (Procedure)
Tamoxifen and bone fracture
Patients randomized to Arm A of Study BIG 1-98 (tamoxifen for 5 years) who have had a bone fracture.
干预措施: spectroscopy (Procedure)
Letrozole and bone fracture
Patients randomized to Arm B of Study BIG 1-98 (letrozole for 5 years) who have had a bone fracture.
干预措施: spectroscopy (Procedure)
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