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Does Omeprazole Decrease Intestinal Calcium Absorption?
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Osteoporosis Achlorhydria GERD Hip Fracture | Drug: Omeprazole | Phase 4 |
| Study Type: | Interventional |
| 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 ]percent calcium absorption
- Change in Bone Resorption From Baseline to 1 Month [ Time Frame: change in bone resorption from baseline to 1 month ]urine n-telopeptide (normalized to creatinine levels)
| Enrollment: | 23 |
| Study Start Date: | January 2008 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Experimental
Subjects will receive omeprazole 40 mg daily for 30 days
|
Drug: Omeprazole
40 mg po qAM one-half hour before breakfast for 30 days
Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Women at least 5 years past menopause, defined as the last date of menses
Exclusion Criteria:
- Allergy/Intolerance to orange juice
- Allergy/Intolerance to omeprazole or other PPI therapy
- Use of drugs that interact with omeprazole including oral anti-fungal agents, coumadin, diazepam, phenytoin & tacrolimus
- Use of antacids, PPI or H2-blocker therapy within the past two months
- 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 metabolism, including oral steroids or anticonvulsants
Contacts and LocationsPlease 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 |
More Information
Publications:
| Responsible Party: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT00582972 History of Changes |
| Other Study ID Numbers: |
H-2007-0179 07-1235-03 |
| Study First Received: | December 19, 2007 |
| Results First Received: | July 6, 2012 |
| Last Updated: | February 14, 2013 |
Keywords provided by University of Wisconsin, Madison:
|
Calcium Absorption Fractional Calcium Absorption Omeprazole |
Stable Calcium Isotopes Proton Pump Inhibitor Intestinal Absorption of Calcium |
Additional relevant MeSH terms:
|
Achlorhydria Osteoporosis Hip Fractures Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Femoral Fractures Fractures, Bone Wounds and Injuries Hip Injuries Leg Injuries Stomach Diseases Gastrointestinal Diseases |
Digestive System Diseases Acid-Base Imbalance Metabolic Diseases Calcium, Dietary Omeprazole Bone Density Conservation Agents Physiological Effects of Drugs Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on July 11, 2017