NCT02528747已完成不适用
A Multi-Center Observational Survey of Breast Cancer Patients With Metastatic Bone Disease Receiving Oral Ibandronate (BONDORAL)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 582
- 主要终点
- Change in bone pain according to Visual Analog Scale (VAS) score
研究概览
简要总结
This observational, multicenter survey is designed to assess the efficacy of oral ibandronate in adults with breast cancer and metastatic bone disease. Data on the use of ibandronate in clinical practice will be collected from Hungarian patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adults at least 18 years of age
- •Histologically confirmed breast cancer with bone metastasis
- •Receiving or indicated for the tablet formulation of ibandronate according to the summary of product characteristics (SmPC) and local labeling
排除标准
- •Contraindication to ibandronate according to SmPC
- •Ongoing participation in any trial evaluating the efficacy and/or safety of ibandronate
结局指标
主要结局
Change in bone pain according to Visual Analog Scale (VAS) score
时间窗: From Baseline to the end of 1 year
次要结局
- Compliance with tablet formulation of ibandronate according to Case Report Form (CRF) questionnaire(Up to approximately 1 year)
- Incidence of adverse events(Up to approximately 1 year)
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