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
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Spine and femur bone change comparison
研究概览
简要总结
RATIONALE: Bisphosphonates, such as risedronate, may help improve bone health and prevent osteoporosis in postmenopausal women. It is not yet known whether risedronate is effective in improving bone mineral density and bone health in women with ductal carcinoma in situ.
PURPOSE: This randomized phase III trial is studying risedronate to see how well it works compared to a placebo in improving bone mineral density and bone health in postmenopausal women with ductal carcinoma in situ enrolled in clinical trial CRUK-IBIS-II-DCIS (CRUK: Cancer Research UK) (DCIS: Ductal carcinoma in situ).
详细描述
OBJECTIVES:
Primary
- Compare the changes in bone of the spine and femur in postmenopausal women with ductal carcinoma in situ treated with anastrozole vs placebo on protocol CRUK-IBIS-II-DCIS.
- Determine the effect of bisphosphonate treatment on bone mineral density and bone metabolism in patients who are receiving anastrozole on protocol CRUK-IBIS-II-DCIS and are osteoporotic or moderately to severely osteopenic at baseline.
Secondary
- Correlate changes in levels of biochemical markers of bone metabolism with longer-term changes in bone mineral density, as measured by dual-energy x-ray absorptiometry (DXA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- Double
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of ductal carcinoma in situ within the past 6 months
- •Locally excised with tumor-free margins at least 1 mm
- •Currently enrolled in protocol CRUK-IBIS-II-DCIS AND randomized to receive either anastrozole or placebo
- •No T-score < -4.0 and/or > 2 low trauma vertebral fractures by dual-energy x-ray absorptiometry (DXA)
- •Hormone receptor status: Estrogen or progesterone receptor positive tumor
- •PATIENT CHARACTERISTICS:
- •Female patient
- •Postmenopausal
- •No prior bilateral hip fracture or bilateral hip prostheses
- •No concurrent metabolic bone disease, including any of the following:
- •Paget's disease
- •Osteogenesis imperfecta
- •Disorders of calcium or mineral metabolism
- •Renal calculus
- •Malabsorption
- •Hypercalcemia or hypocalcemia
- •Hyperparathyroidism or hypoparathyroidism
- •Hyperthyroidism or hypothyroidism
- •Patients on stable replacement therapy are allowed provided they are euthyroid
- •PRIOR CONCURRENT THERAPY:
- •More than 12 months since prior medication affecting bone metabolism, including any of the following:
- •Any bisphosphonate
- •Parathyroid hormone
- •Calcitonin
- •Oral or systemic glucocorticoids
排除标准
- 未提供
结局指标
主要结局
Spine and femur bone change comparison
Effects of bisphosphonate on bone mineral density and bone metabolism in patients who were osteoporotic or moderately severe osteopenic at baseline
次要结局
- Correlation of changes in levels of biochemical markers of bone metabolism with longer-term changes in bone mineral density as measured by dual-energy x-ray absorptiometry (DXA)