Traditional Chinese Medicine as Preventive Method for Osteoporosis in Early Breast Cancer Patients Receiving Adjuvant Endocrine Therapy

Shanghai Jiao Tong University School of Medicine1 个研究点分布在 1 个国家目标入组 278 人开始时间: 2015年5月最近更新: 2020年4月14日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 278
试验地点: 1
主要终点: Change of Bone Mineral Density

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To test the efficacy of two Traditional Chinese Medicine in preventing osteoporosis in patients receiving adjuvant endocrine therapy.

详细描述

Breast cancer is the most common malignant tumor in female wolrdwide. Results from clinical trials like ATAC trial have demonstrated the efficacy of AIs in postmenopausal breast cancer patients. Meanwhile it may cause a certain rate of osteoporosis in postmenopausal patients. The aim of this trial is to test the efficacy of two traditional Chinese medicine in preventing osteoporosis in patients receiving adjuvant endocrine therapy.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
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

•Histologically confirmed invasive breast cancer;
•Post-surgery, primary lesion been removed;
•Post-Menopausal patients or pre-menopausal patients who will receive ovarian function suppression;
•Histologically confirmed ER and/or PR positive ;
•Receiving adjuvant AIs therapy in the following one years;
•Leukocyte ≥ 3*10(9)/L; Platelets ≥ 75*10(9)/L;
•Serum glutamate oxaloacetate(AST/SGOT) or serum glutamic-pyruvic transaminase(ALT/SGPT) <2.5 times of upper limit of normal range;
•Serum creatinine/blood urea nitrogen(BUN) ≤ upper limit of normal (UNL) range;
•Written informed consent according to the local ethics committee equirements;

排除标准

•Metastatic Breast Cancer;
•Received Neo-Adjuvant Endocrine Therapy;
•History of pelvic fracture or bone metabolic disease;
•Received drugs interfering bone metabolism in the last 12 months;
•Baseline Bone Mineral Density: T < -2SD;
•With other primary malignant disease;
•With severe non-malignant co-morbidity that will influence long-term follow up;
•Known severe hypersensitivity to any drugs in this study;