Zoledronic Acid for Treatment of Osteopenia and Osteoporosis in Women With Primary Breast Cancer Undergoing Adjuvant Aromatase Inhibitor (Letrozole) Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD)
研究概览
简要总结
RATIONALE: Zoledronate may reduce bone loss in patients receiving letrozole for breast cancer.
PURPOSE: This clinical trial is studying how well zoledronate works in treating osteopenia or osteoporosis in postmenopausal women receiving letrozole for stage I, stage II, or stage IIIA primary breast cancer.
详细描述
OBJECTIVES:
Primary
- Assess changes in total lumbar spine bone mineral density (BMD) from baseline to 12 months in postmenopausal women treated with zoledronate for osteopenia or osteoporosis and letrozole for hormone receptor-positive, stage I-IIIA primary breast cancer.
Secondary
- Determine changes in total lumbar spine BMD from baseline to 2, 3, 4, and 5 years in these patients.
- Determine changes in femoral neck BMD from baseline to 1, 2, 3, 4, and 5 years in these patients.
- Determine time to disease progression in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（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
研究组 & 干预措施
zoledronic acid
4 mg 15 minutes IV infusion. If creatinine clearance is ≤ 60, dosage should be adjusted as follows:CrCl 50-60: 3.5 mg; CrCl 40-49: 3.3 mg; CrCl 30-39: 3.0 mg.
干预措施: zoledronic acid (Drug)
zoledronic acid
4 mg 15 minutes IV infusion. If creatinine clearance is ≤ 60, dosage should be adjusted as follows:CrCl 50-60: 3.5 mg; CrCl 40-49: 3.3 mg; CrCl 30-39: 3.0 mg.
干预措施: Letrozole as adjuvant therapy (Procedure)
结局指标
主要结局
Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD)
时间窗: Baseline and 1 year
Change: BMD values at twelve months post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.
次要结局
- Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 2 Post Study Entry(Baseline and 2 year)
- Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 4 Post Study Entry(Baseline and 4 year)
- Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 3 Post Study Entry(Baseline and 3 year)
- Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD) at Year 5 Post Study Entry(Baseline and 5 year)
- Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 2 Post Study Entry(Baseline and 2 year)
- Maximum-Grade Toxicity Incidence at Least Possibly Related to Study Medications(5 years)
- Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 1 Post Study Entry(Baseline and 1 year)
- Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 3 Post Study Entry(Baseline and 3 year)
- Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 4 Post Study Entry(Baseline and 4 year)
- Average Intra-patient Change in Femoral Neck Bone Mineral Density (BMD) at Year 5 Post Study Entry(Baseline and 5 year)
- Time to Disease Progression(Up to 5 years)