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临床试验/NCT00762294
NCT00762294已完成不适用

Effect Of Anastrozole And Letrozole On Bone Turnover Markers And Bone Mineral Density In Postmenopausal Women With Primary Breast Cancer: A Pilot Study

UConn Health1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2007年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
bone density

研究概览

简要总结

Aromatase Inhibitors (AI) are effective for secondary prevention of breast cancer and may soon replace tamoxifen as first-line therapy in the treatment of hormone-sensitive breast cancer. However, because these medications produce a marked reduction in serum estrogen levels, this is likely to result in an increased rate of bone loss and risk of developing osteoporosis and fractures in postmenopausal women treated with these agents. Indeed, substantial bone loss has been reported in several large clinical trials of AIs. Osteoporosis drugs are available that could prevent this loss, but they have frequent side effects and are expensive. Thus, treating all women receiving AIs might not be the most appropriate and cost-effective approach. A better approach might be to select women at highest risk of bone loss and only treat them with antiresorptive agents.

The proposed pilot study will evaluate women who receive anastrozole or letrozole therapy, are receiving adequate amounts of calcium and vitamin D and have baseline normal or moderately low bone mass in order to determine if early changes in bone turnover markers correlate with bone loss at one year. If data from this pilot protocol support our hypothesis, then we would propose a larger trial to confirm it. The ultimate aim is to predict which women are at higher risk of bone loss and therefore treat them earlier with bone-sparing agents, while those with lower risk could be monitored on conservative therapy.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Postmenopausal women with diagnosis of breast cancer - have not started Arimidex or Femara yet, but will be starting .

排除标准

  • History of metastasis
  • History of chronic kidney
  • Liver GI disease
  • Disorders affecting calcium metabolism

结局指标

主要结局

bone density

时间窗: baseline, 6 months, 12 months

次要结局

  • bone markers(baseline, 1 month, 3 month, 6 month, 12 month)

研究者

发起方
UConn Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pamela Taxel

Associate Professor of Medicine

UConn Health

研究点 (1)

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