NCT00323479已完成4 期
A Multicentre, Open Study Assessing Joint Disorders Under ARIMIDEX® (1mg/Day) as Adjuvant Treatment in Post Menopausal Women With Early Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 114
- 试验地点
- 5
- 主要终点
- Number of Participants With New Events of Arthralgia
研究概览
简要总结
The purpose of this study is to describe the joint symptoms and structural joint changes under anastrozole as adjuvant treatment in postmenopausal women with early breast cancer.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Post menopausal woman with a breast cancer and scheduled for an adjuvant treatment with anastrozole
- •WHO performance status 0, 1 or 2
- •Provision of written informed consent
排除标准
- •Recurrence of breast cancer, inflammatory rheumatism
- •treatment by chondromodulator, oral glucocorticoid, aromatase inhibitor, anti estrogen, Herceptin
- •Diabetes treated by insulin
- •Severe renal or hepatic disease
- •Known hypersensitivity to anastrozole
结局指标
主要结局
Number of Participants With New Events of Arthralgia
时间窗: 12 months
次要结局
- Functional Index of Cochin at 12 Months in Patients Under Anastrozole.(12 months)
- Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole(12 months)
- Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole(12 months)
- Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole(12 months)
- Percentage of Participant With Therapeutic Maintenance Under Anastrozole(12 months)
研究者
研究点 (5)
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