Do Aromatase Inhibitors (AIs) Decrease Intestinal Calcium Absorption?
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|ClinicalTrials.gov Identifier: NCT00766532|
Recruitment Status : Completed
First Posted : October 6, 2008
Results First Posted : September 14, 2012
Last Update Posted : September 14, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Osteoporosis Osteopenia Fracture||Drug: Aromatase Inhibitor||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Do Aromatase Inhibitors (AIs) Decrease Intestinal Calcium Absorption?|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
Experimental: aromatase inhibitor therapy
aromatase inhibitor therapy for six weeks
Drug: Aromatase Inhibitor
Any aromatase inhibitor started as initial adjuvant therapy
- Change in Intestinal Calcium Absorption Related to Aromatase Inhibitor Therapy [ Time Frame: baseline and 6 weeks later ]intestinal calcium absorption
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00766532
|Principal Investigator:||Karen E Hansen, MD||University of Wisconsin, Madison|