NCT00766532

Do Aromatase Inhibitors (AIs) Decrease Intestinal Calcium Absorption?

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Osteoporosis
• Osteopenia
• Fracture

Interventions

Type	Name	Description
DRUG	Aromatase Inhibitor	Any aromatase inhibitor started as initial adjuvant therapy

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2008-10-06
• Last updated: 2012-09-14
• Results posted: 2012-09-14