Bone Metabolic Markers, TRAP, and Zometa's Effect on Bone Metastasis Due to Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Average Percent Change From Baseline in TRAP Levels at 2 Weeks
研究概览
简要总结
The purpose of this study is to evaluate a new blood test as a way to follow the effect of Zometa in treating bone metastases due to lung cancer.
详细描述
The purpose of this research study is to evaluate a new blood test as a way to follow the effect of Zometa in treating bone metastases. The blood test will look for a protein, called TRAP, which is released into the blood stream by the breakdown of bone. This study will compare the TRAP blood test with other blood tests for bone destruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •invasive lung cancer (small cell or non-small cell lung cancer)
- •osteolytic bone metastasis determined by clinical exam, bone scan/XR
- •age > 18 years
排除标准
- •concurrent malignancy with a second primary
- •renal failure (serum creatinine > 3mg/dl)
- •pregnancy
- •active rheumatoid arthritis
- •intolerance to zoledronic acid
研究组 & 干预措施
zoledronic acid
3.0-4.0 mg by IV (in the vein), once a month for 6 months
干预措施: zoledronic acid (Drug)
结局指标
主要结局
Average Percent Change From Baseline in TRAP Levels at 2 Weeks
时间窗: TRAP levels at Baseline and 2 weeks after first Zometa infusion
Change was calculated as 100% (value at baseline minus value at 2 weeks)/value at baseline
次要结局
未报告次要终点
研究者
Goetz Kloecker
Assoc Professor
James Graham Brown Cancer Center