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临床试验/NCT00114270
NCT00114270已完成不适用

Evaluating the Effect of Letrozole With or Without Concomitant Zoledronic Acid on Estrogen Responsive Targets in Postmenopausal Women

University of Virginia2 个研究点 分布在 1 个国家开始时间: 2004年5月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
试验地点
2

研究概览

简要总结

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may prevent breast cancer by lowering the amount of estrogen the body makes. Zoledronate may prevent bone loss caused by letrozole. Giving letrozole together with zoledronate may prevent breast cancer and reduce bone loss.

PURPOSE: This randomized clinical trial is studying letrozole and zoledronate to see how well they work compared to letrozole and placebo or placebo alone in treating healthy postmenopausal women with high breast density.

详细描述

OBJECTIVES:

Primary

  • Compare the percent change in breast density in healthy postmenopausal women with high breast density treated with placebo only vs letrozole and placebo vs letrozole and zoledronate.
  • Compare the percent change in biochemical markers of bone turnover in participants treated with these regimens.

Secondary

  • Compare the bone density in participants treated with these regimens.
  • Compare growth hormone release and insulin-like growth factor levels in participants treated with these regimens.
  • Compare the incidence and severity of adverse events in participants treated with these regimens.

研究设计

研究类型
Interventional
分配方式
Randomized
主要目的
Prevention
盲法
Double

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Other

研究点 (2)

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