Status:
COMPLETED
Do Aromatase Inhibitors (AIs) Decrease Intestinal Calcium Absorption?
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Breast Cancer
Osteoporosis
Eligibility:
FEMALE
Phase:
PHASE4
Brief Summary
Research Question: Do Aromatase Inhibitors Decrease Intestinal Calcium Absorption? Study Design: Postmenopausal women with early stage breast cancer initiating aromatase inhibitor adjuvant therapy wi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00766532
Start Date
January 1 2009
End Date
October 1 2010
Last Update
September 14 2012
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