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| Tracking Information | |||||
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| First Received Date ICMJE | December 19, 2007 | ||||
| Last Updated Date | June 19, 2009 | ||||
| Start Date ICMJE | January 2008 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in intestinal calcium absorption after one month of omeprazole therapy [ Time Frame: 2 months ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00582972 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
The change in bone resorption (urine n-telopeptide) after one month of omeprazole therapy and the month-to-month variability in intestinal calcium absorption. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Does Omeprazole Decrease Intestinal Calcium Absorption? | ||||
| Official Title ICMJE | Does Omeprazole Decrease Intestinal Calcium Absorption? | ||||
| Brief Summary | The purpose of this study is to measure the effect of omeprazole on intestinal calcium absorption in postmenopausal women. Because older adults frequently take PPI, it is critical to understand the impact of PPI therapy on calcium homeostasis. In this study, I hypothesize that PPI therapy does not alter intestinal calcium absorption in postmenopausal women. |
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| Detailed Description | Existing literature makes it unclear whether PPI therapy truly decreases intestinal calcium absorption. Up to 25 postmenopausal women will participate in this two-month study. The primary study outcome is the change in intestinal calcium absorption following omeprazole therapy. The secondary outcomes include the change in urine n-telopeptide, the month-to-month variability in intestinal calcium absorption and the establishment of a DNA bank for genetic studies of calcium homeostasis. We will interview women and review their medical records to determine eligibility. Eligible subjects will undergo three GCRC 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 GCRC 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 or second GCRC 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 and save it indefinitely within the locked GRECC Drezner Laboratory (5th Floor, VA Hospital) permitting future genetic studies related to calcium homeostasis. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Other, Non-Randomized, Open Label, Single Group Assignment | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Omeprazole | ||||
| Study Arms / Comparison Groups | Experimental: Subjects will receive omeprazole 40 mg daily for 30 days | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 21 | ||||
| Completion Date | December 2008 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | |||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00582972 | ||||
| Responsible Party | Karen Hansen, MD, University of Wisconsin School of Medicine and Public Health | ||||
| Study ID Numbers ICMJE | H-2007-0179, 07-1235-03 | ||||
| Study Sponsor ICMJE | University of Wisconsin, Madison | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of Wisconsin, Madison | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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