ACTRN12605000222640已完成3 期
International Breast cancer Intervention Study (IBIS-II) Bone Sub-Protocol, A randomised double-blind trial to assess the effects on bone mineral density and bone biomarkers of anastrozole when used to prevent breast cancer in postmenopausal women
Australia and New Zealand Breast Cancer Trials Group0 个研究点目标入组 1,000 人开始时间: 2005年8月26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
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 70 Years（—）
- 性别
- Female
入选标准
- •Women meeting the entry criteria of the IBIS-II (Prevention) trial will be offered entry into the bone sub-protocol. Women will be selected from the first women randomised into the main trial, and will be enrolled for the sub-protocol subject to: (1) giving informed consent; (2) not being excluded by one or more of the exclusion criteria listed below. Women with T-scores < -2.5 and > -4.0 or 1-2 low trauma vertebral fractures must be treated with risedronate.
排除标准
- •criteria: 1. Women with previous bilateral hip fractures or bilateral hip prostheses. This is because reliable DXA scans cannot be performed.2. Women currently with any type of metabolic bone disease including: Paget's disease, osteogenesis imperfecta, disorders of calcium or mineral metabolism, renal calculus, malabsorption, hyper- or hypocalcaemia, hyper- or hypoparathyroidism, hyper- or hypothyroidism (NB: women on stable thyroid replacement therapy can be included provided they are euthyroid as judged by the investigator). Women with previous conditions that have been corrected are eligible.3. Women who have regularly taken any medication affecting bone metabolism within the past 12 months including oestrogen, any bisphosphonate, parathyroid hormone, calcitonin, oral or systemic glucocorticoid.However, women who have been diagnosed as osteoporotic and are currently taking oral bisphosphonate can join stratum III of the bone sub-study providing their T-score is <-2.5 at the time of randomisation (DXA scan done within 3 months of joining the study).4. Women who have a T score less than -4 and/or more than 2 low trauma vertebral fractures.
研究者
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