NCT00029224已完成4 期
A Prospective, Multicenter, Open-label Clinical Evaluation of the Effect of IV Zoledronic Acid 4mg on PAIN, QUALITY OF LIFE and TIME IN INFUSION CHAIR in Breast Cancer, Multiple Myeloma, and Prostate Cancer Patients With Cancer-related Bone Lesions
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 500
- 试验地点
- 14
- 主要终点
- Pain score assessed by change from baseline
研究概览
简要总结
Patients with bone metastases or bone lesions caused by breast cancer, multiple myeloma or prostate cancer will be treated with IV Zometa in a 15 minute infusion. Pain will be evaluated, as well as time in chair, quality of life and safety of Zometa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Signed informed consent
- •Greater than 18 years of age
- •Proof of breast cancer, multiple myeloma or prostate cancer
- •Diagnosis of at least one cancer-related bone lesion
- •If patient is of child-bearing potential, negative pregnancy test and on a medically recognized form of contraception
- •ECOG performance status of 0,1 or 2
- •Ability to read, understand and write English or Spanish language
- •Normal renal function
- •Corrected serum calcium equal to or greater than 8mg/dl
排除标准
- •clinically symptomatic brain metastases
- •hypersensitivity to Zometa or other bisphosphonates
- •pregnant or lactating
结局指标
主要结局
Pain score assessed by change from baseline
次要结局
- Quality of life
- Time in infusion chair
- Safety assessed by adverse events (AEs)
研究者
研究点 (14)
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