ISRCTN13914201已完成3 期
A randomised pragmatic open-label, multicentre, non-crossover clinical study to evaluate and compare the efficacy, safety profile and tolerability of oral ibandronate versus intravenous (iv) zoledronate in the treatment of breast cancer patients with bone metastases
Velindre NHS Trust0 个研究点目标入组 1,400 人开始时间: 2005年4月13日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,400
研究概览
简要总结
2013 sub-study results in: http://www.ncbi.nlm.nih.gov/pubmed/24107437
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Patients with newly diagnosed (<3 months) multiple bone metastases from histologically proven breast cancer and considered suitable for treatment with a bisphosphonate
- •2. Isotope bone scan within 6 weeks prior to screening to provide evidence of multiple bone metastases
- •3. Patients may also be receiving chemotherapy and/or hormone therapy for metastatic disease
- •4. Patients with multiple (>1) bone metastases (painful or asymptomatic) of lytic, mixed or purely sclerotic type
- •5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
排除标准
- •1. Patients with a creatinine clearance of less than 30 ml/minute
- •2. Patients with serum bilirubin/aspartate transaminase (AST) (alanine transaminase [ALT]) raised more than 1.5 times normal
- •3. Patients with central nervous system (CNS) metastases
- •4. Patients who have undergone dental procedures in the 2 months prior to randomisation
- •5. Patients with known active peptic ulcer
- •6. Patients with hypocalcaemia within 6 weeks of randomisation
- •7. Patients who have received bisphosphonate therapy in the previous 6 months
研究者
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