Phase 4
N=23
Does Omeprazole Decrease Intestinal Calcium Absorption?
Osteoporosis · Achlorhydria · GERD · Hip Fracture
Bottom Line
View on ClinicalTrials.gov: NCT00582972 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Change in Intestinal Calcium Absorption From Baseline to One Month — 5 percent calcium absorption
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Omeprazole (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Intestinal Calcium Absorption From Baseline to One Month |
5 | — |
| SECONDARY Change in Bone Resorption From Baseline to 1 Month |
1.9 | — |
Summary
The purpose of this study is to measure the effect of omeprazole on intestinal calcium absorption in postmenopausal women.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00582972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.