Do Aromatase Inhibitors (AIs) Decrease Intestinal Calcium Absorption?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Change in Intestinal Calcium Absorption Related to Aromatase Inhibitor Therapy
研究概览
简要总结
Research Question: Do Aromatase Inhibitors Decrease Intestinal Calcium Absorption?
Study Design: Postmenopausal women with early stage breast cancer initiating aromatase inhibitor adjuvant therapy will participate in this two-month study. The primary study outcome is the change in intestinal calcium absorption following such therapy. Secondary outcomes are the changes in bone resorption markers and musculoskeletal signs and symptoms after initiation of therapy.
We will interview women and review their medical records to determine eligibility. Eligible subjects will undergo two calcium absorption studies. The first study will determine their baseline calcium absorption, and the second study will occur after taking an aromatase inhibitor daily for at least 6 weeks. Women will present to the research unit in the early morning and receive an oral and intravenous stable calcium tracer with breakfast. Over the next 24 hours, we will collect all urine for measurement of its calcium content. During each inpatient stay, we will assess musculoskeletal symptoms by questionnaire and joint examination. Each woman will complete a four-day diet diary twice during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women at least 5 years past menopause, defined as date of last menses or bilateral oophorectomy
- •Newly diagnosed breast cancer and starting an AI as initial adjuvant therapy
- •Exclusion Criteria
- •Recent, current or planned chemotherapy for breast cancer, as this may have independent effects on intestinal health, calcium homeostasis and bone turnover
- •Allergy or intolerance to orange juice, as one isotope is given with orange juice
- •Current use of over-the-counter or prescription antacids, as they may influence Ca-Ab
- •Intestinal conditions associated with malabsorption or low gastric acid levels including Crohn's disease, ulcerative colitis, pernicious anemia, bacterial overgrowth, celiac sprue, chronic diarrhea or use of antibiotics within the past month
- •Known Stage 4 or 5 Chronic Kidney Disease, defined as an estimated GFR <30 cc/minute
- •Use of medications known to interfere with calcium or vitamin D metabolism, including oral steroids or anticonvulsants
- •Significant lymphedema precluding adequate intravenous access
排除标准
- 未提供
研究组 & 干预措施
aromatase inhibitor therapy
aromatase inhibitor therapy for six weeks
干预措施: Aromatase Inhibitor (Drug)
结局指标
主要结局
Change in Intestinal Calcium Absorption Related to Aromatase Inhibitor Therapy
时间窗: baseline and 6 weeks later
intestinal calcium absorption
次要结局
未报告次要终点