Do Aromatase Inhibitors (AIs) Decrease Intestinal Calcium Absorption?
Status:
Completed
Trial end date:
2010-10-01
Target enrollment:
Participant gender:
Summary
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.