Systemic DKK1 During Estrogen Level Changes in Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Estrogen level suppresses DKK1
研究概览
简要总结
The investigators are hypothesizing that decreasing estrogen levels will cause serum DKK1 to peak, then decrease gradually as estrogens reach a new lower, but steady level. The investigators also believe that the peak in DKK1 will initiated a wave of stem cell diversion from the osteoblastogenic pathway to the adipogenic pathway.
The investigators will conduct a longitudinal cohort study of post menopausal women with hormone-responsive breast cancer that will be treated AIs. The study will observe anthromorphic and serum marker changes during the first year of their treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Post Menopausal Breast cancer patients with planned treatment of aromatase inhibitors.
- •18 years or older
排除标准
- •BMI >30 or <18
- •Osteoporosis as defined by protocol.
- •Subjects currently on bisphosphonate therapy.
- •History of primary or secondary hyperparathyroidism
- •History of Hypo-or Hyperthyroidism
- •History of Vitamin D levels below LLN
- •History of creatinine clearance below the EGFR
- •History ofLiver function tests above 1.5 times ULN including LDH, SGOT, SGPT, Alkaline phosphatase, and Bilirubin
- •History of documented cirrhosis of the liver
- •History of chronic heparin use
- •History of chronic glucocorticoid therapy
结局指标
主要结局
Estrogen level suppresses DKK1
时间窗: 26 weeks
With the start of AI treatment, estrogen levels will decline to almost undetectable levels. We believe this decrease in estrogen will lift suppression of DKK1 and allow its expression to peak during the 1st month of treatment, and decline more slowly thereafter. During the first 26 weeks of treatment, we expect levels of CTx to rise, PTH to fall, and P1NP to show no change, findings that would be consistent with Heshmati's study.
次要结局
未报告次要终点