University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
NCT Number: NCT00582972
The purpose of this study is to measure the effect of omeprazole on intestinal calcium absorption in postmenopausal women.
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Interventional
Phase 4
Madison, Wisconsin, 53792, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
40 mg po qAM one-half hour before breakfast for 30 days
Other names: Losec, Prilosec
Time frame: change in calcium absorption from baseline to 1 month
percent calcium absorption
Time frame: change in bone resorption from baseline to 1 month
urine n-telopeptide (normalized to creatinine levels)
University of Wisconsin, Madison
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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