NCT00122356已完成3 期
Maintaining Skeletal Health in Postmenopausal Women With Surgically Resected Stage I-IIIa Hormone-receptor Positive Breast Cancer Who Are Receiving Anastrozole, Through the Use of Alendronate as Determined by the Osteoporosis Australia Bone Maintenance Algorithm
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 8
- 主要终点
- Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment
研究概览
简要总结
The purpose of this study is to evaluate the use of an oral bisphosphonate (alendronate) in preventing bone loss in postmenopausal women with early breast cancer who are receiving anastrozole therapy, and to determine how long alendronate treatment is needed.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal
- •Adequately diagnosed and treated Stage I-IIIa early breast cancer
- •Oestrogen receptor and/or progesterone receptor positive breast cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- •Hormone replacement therapy (HRT) must be discontinued at least 2 weeks prior to registration
- •Any prior tamoxifen taken for a total of 8 weeks or less
- •Any prior anastrozole taken for a total of 4 weeks or less
- •Anastrozole is clinically indicated to be the best adjuvant strategy
- •Signed written informed consent
排除标准
- •Clinical or radiological evidence of distant spread of disease
- •Prior treatment with bisphosphonates within the past 12 months
- •Prior treatment with continuous systemic corticosteroids within the past 12 months
- •Prior use of parathyroid hormone for more than 1 week
- •Prior use of systemic sodium fluoride for > 3 months during the past 2 years
- •Currently treated with any drugs known to affect the skeleton
- •Abnormal renal function (serum creatinine greater than or equal to 265.2 mmol/L)
- •History of diseases with influence on bone metabolism. Patients with lactose intolerance are also excluded
- •Delayed oesophageal emptying such as stricture or achalasia
- •Hypersensitivity to alendronate or anastrozole
- •Previous or concomitant malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix
- •AST/SGOT and/or ALT/SGPT > 3 x ULN in combination with other laboratory and clinical abnormalities indicating liver insufficiency
- •Fracture due to minimal trauma, demonstrated radiologically
研究组 & 干预措施
Anastrozole and alendronate
Other
Patients will receive anastrozole for 5 years and alendronate for 3 years or anastrozole and alendronate treatment for 5 years.
干预措施: Alendronate sodium (Drug)
结局指标
主要结局
Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment
时间窗: 5 years
次要结局
- Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD(12 monthly intervals)
- Biochemical markers of bone turnover (N-telopeptide and bone-specific alkaline phosphatase) and BMD(6 months after registration and/or 6 months after commencing alendronate)
- Evaluate the Osteoporosis Australia strategy for bone protection for this patient group(5 years)
- Evaluate the clinical fracture incidence cumulative over 5 years(5 years)
- Perform an economic analysis of the cost of monitoring and intervention(5 years)
- Evaluate the time to disease recurrence/relapse in women treated with anastrozole as adjuvant therapy(5 years)
- Evaluate the effects of anastrozole on serum lipid parameters following 6 months therapy(6 months)
研究者
研究点 (8)
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