NCT02716792已完成3 期
Randomized, Open Label Study to Evaluate Renal Safety of Intravenous Bondronat 6 mg Infusions Over 15 Minutes Versus 60 Minutes in Patients With Metastatic Bone Disease Due to Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 334
- 主要终点
- Creatinine clearance (CrCl) Estimated by Cockcroft-Gault Formula
研究概览
简要总结
This study will evaluate renal function in participants with metastatic bone disease due to breast cancer receiving intravenous (IV) infusions of ibandronate (Bondronat) 6 milligrams (mg), over either 15 minutes or 60 minutes, every 3 weeks. Efficacy and safety of ibandronate in the 2 groups of participants will also be compared. The anticipated time on study treatment is 7 months, and the target sample size is 318 individuals.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •For participants of childbearing potential: negative pregnancy test and ready to use effective contraceptive measures
- •Metastatic breast cancer with at least one bone metastasis
- •Karnofsky index >/= 60
- •Life expectancy >/= 6 months
- •Estimated creatinine clearance (Cockcroft and Gault formula) >/= 30 milliliters per minute (mL/min)
排除标准
- •Pregnancy or breast feeding participant
- •Participant who had a current dental problem, particularly tooth or jaw infection, trauma or surgery on tooth or jaw in the previous six weeks, medical history of jaw osteonecrosis or delayed healing after dental surgery
- •Participant who was participating or had participated in the last 30 days to a clinical trial investigating treatments
- •Uncontrolled brain metastasis
- •Severe or concomitant infection
- •Known medical history of systemic disease with renal lesion
- •Rapidly progressing renal failure at inclusion
- •Uncontrolled cardiac disorder
- •Hypercalcaemia (> 2.7 millimoles per liter [mmol/L]), hypocalcaemia (< 2 mmol/L)
- •Participant receiving nephrotoxic chemotherapy
- •Participant eligible for haematopoietic stem cell transplantation at inclusion time
- •Bisphosphonate therapy in the 3 weeks before randomization
- •Known hypersensitivity to ibandronate or other bisphosphonates
研究组 & 干预措施
Ibandronate 15-Minute Infusion
Experimental
Participants will receive ibandronate IV infusions over a 15-minute interval.
干预措施: Ibandronate (Drug)
Ibandronate 60-Minute Infusion
Active Comparator
Participants will receive ibandronate IV infusions over a 60-minute interval.
干预措施: Ibandronate (Drug)
结局指标
主要结局
Creatinine clearance (CrCl) Estimated by Cockcroft-Gault Formula
时间窗: 28 days after last infusion (approximately 2 years)
次要结局
- Number of Participants with Bone Pain According to Visual Analog Scale (VAS)(Every 3 weeks up to approximately 6 months)
- Karnofsky Index score(Every 3 weeks up to approximately 6 months)
- Number of Participants With of Skeletal Events (Vertebral and Non-Vertebral Fractures, Impending Fracture, Radiotherapy or Surgery to Bone)(Up to approximately 7 months)
- Percentage of Participants on Analgesics According to World Health Organization (WHO) Three-Step Analgesic Ladder(Up to approximately 7 months)
研究者
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