Bone Mineral Density Effects of Zoledronate in Postmenopausal Women With Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Change in Bone Mineral Density (BMD) From Baseline to 1 Year
研究概览
简要总结
This is a two arm, double-blind randomized study looking at the effect of zoledronate, a bisphosphonate, on the bone mineral density (BMD) of postmenopausal women with breast cancer.
详细描述
This is a two arm, double-blind randomized study looking at the effect of zoledronate, a bisphosphonate, on the bone mineral density (BMD) of postmenopausal women with breast cancer. An approved bisphosphonate, alendronate, is of benefit in patients with osteoporosis, however, this agent has a roughly 30% incidence of gastrointestinal symptoms and up to 50% of patients may take the drug improperly, compromising absorption and potentially efficacy. Zoledronate is a heterocyclic imidazole third generation bisphosphonate, which is administered intravenously (IV) and has little toxicity. Zoledronate is more potent than alendronate, and because of its route of administration it does not have the problems of poor oral bioavailability and non-compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Postmenopausal women, Stage III or axillary node positive
- •Currently disease free of breast cancer and other invasive malignancies at the time of registration
- •No concurrent use of bisphosphonates
排除标准
- •Metastatic disease
研究组 & 干预措施
Zoledronate
Zoledronate
干预措施: Zoledronate (Drug)
结局指标
主要结局
Change in Bone Mineral Density (BMD) From Baseline to 1 Year
时间窗: Up to 1 year
To determine whether zoledronate 4 mg IV every 12 weeks x 4 doses is associated with increases in bone mineral density at the lumbar spine and femoral head, calculated from baseline and 1 year data. Participants who missed one or more DXA were not evaluated.
次要结局
- Rates of Metastases(Up to 1 year)
- Overall Survival(Up to 10 years)
- Clinical Toxicity of ZA(Up to 1 year)