NCT00458796终止不适用
Cost-Effective Use of Bisphosphonates in Metastatic Bone Disease - A Comparison of Bone Marker Directed Zoledronic Acid Therapy to a Standard Schedule
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,500
- 试验地点
- 60
- 主要终点
- Hypercalcemia of malignancy
研究概览
简要总结
RATIONALE: Zoledronic acid may help decrease the risk of broken bones, bone pain, and other symptoms caused by bone metastases. It may also help patients live more comfortably.
PURPOSE: This randomized clinical trial is studying different schedules of zoledronic acid to compare how well they work in treating patients with breast cancer that has spread to the bone.
详细描述
OBJECTIVES:
Primary
- Compare the frequency and timing of serious related events (e.g., fractures, radiotherapy to bone, hypercalcemia of malignancy, orthopedic surgery, and spinal cord compression) in patients with advanced breast cancer metastatic to the bone treated with bone marker-directed schedule vs standard schedule zoledronic acid.
Secondary
- Compare the quality of life of patients treated with these regimens.
- Compare the clinical burden of skeletal complications in these patients.
- Compare pain, performance status, and analgesic use (PPA score) in these patients.
- Compare the incidence of new bone metastases in these patients.
- Compare overall survival of these patients.
- Compare bisphosphonate use and expenditure on administration in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- All
- 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
Hypercalcemia of malignancy
Fractures
Radiotherapy to bone either for relief of pain or to treat or prevent pathological fractures or spinal cord compression
Orthopedic surgery to prevent or treat pathological fractures or spinal cord compression
Spinal cord compression
次要结局
- Health care utilization
- Quality of life as measured by QLQ-C30 and the QLQ-BR23 breast-specific module
- Clinical burden of skeletal complications
- Pain, performance status, and analgesic use
- Incidence of new bone metastases
- Overall survival
- Bisphosphonate use and expenditure on administration
- Clinical utility of the "point of care" test for N-telopeptides (NTx) excretion
研究者
研究点 (60)
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