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Do Aromatase Inhibitors (AIs) Decrease Intestinal Calcium Absorption? - NCT00766532-53792(Clinical Trial 244792)



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City:  Madison
State:  
WI
Zip Code: 53792
Conditions: Breast Cancer - Osteoporosis - Osteopenia - Fracture - Fall
Purpose: Research Question: Do Aromatase Inhibitors (AIs) Decrease Intestinal Calcium Absorption? Study Design: Up to 10 post-menopausal women with early stage breast cancer initiating an AI as adjuvant therapy will participate in this two-month study. The primary study outcome is the change in intestinal calcium absorption following AI 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 CTRC studies. The first study will determine their baseline calcium absorption, and the second study will occur after taking an AI daily for at least 6 weeks. Women will present to the CTRC 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. Major Risks: The study confers no major risks. We describe minor risks in the protocol and consent form. Potential Benefits: Subjects receive no direct benefits from the study. Information on how AIs affect calcium absorption is of great import, as AIs are standard therapy in post-menopausal women with breast cancer and often cause bone loss. Consent Procedure: Interested subjects will receive a verbal description of the study along with the consent form and HIPAA document. We will answer all subjects' questions regarding the study. Consenting volunteers will receive a copy of the consent form and HIPAA documents.
Study summary:
Criteria: 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
Study is available at: University of Wisconsin School of Medicine and Public Health
Madison, WI 53792
United States

Primary Contact:
Karen E Hansen, MD
Email: KEH@medicine.wisc.edu
Phone: 608-263-0517

Secondary Contact:
Karen E Hansen, MD
Email: KEH@medicine.wisc.edu
Phone: (608) 263-0517
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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