Does Omeprazole Decrease Intestinal Calcium Absorption?
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Does Omeprazole Decrease Intestinal Calcium Absorption?|
- Change in Intestinal Calcium Absorption From Baseline to One Month [ Time Frame: change in calcium absorption from baseline to 1 month ] [ Designated as safety issue: Yes ]percent calcium absorption
- Change in Bone Resorption From Baseline to 1 Month [ Time Frame: change in bone resorption from baseline to 1 month ] [ Designated as safety issue: Yes ]urine n-telopeptide (normalized to creatinine levels)
|Study Start Date:||January 2008|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Subjects will receive omeprazole 40 mg daily for 30 days
40 mg po qAM one-half hour before breakfast for 30 days
Existing literature makes it unclear whether proton pump inhibitor therapy truly decreases intestinal calcium absorption. Up to 25 postmenopausal women will participate in this study. The primary study outcome is the change in intestinal calcium absorption following omeprazole therapy 40 mg daily for 30 days. The secondary outcomes include the change in urine n-telopeptide.
We will interview women and review their medical records to determine eligibility. Eligible subjects will undergo three calcium absorption studies. The first 2 studies will determine the monthly variation in calcium absorption, while the 3rd study will occur after taking 40 mg of omeprazole daily for 30 days. Women will present to the research unit in the early morning and receive an oral and intravenous calcium tracer with breakfast. Over the next 24 hours, we will collect all urine for measurement of its calcium content. During the first stay, we will measure each subject's gastric pH by collecting gastric fluid from a temporary nasogastric tube. In consenting subjects we will collect one tube of blood, isolate its DNA.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00582972
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Karen E Hansen, MD||Univeristy of Wisconsin School of Medicine and Public Health|