Does Omeprazole Decrease Intestinal Calcium Absorption?

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-12-31

Brief Summary

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The purpose of this study is to measure the effect of omeprazole on intestinal calcium absorption in postmenopausal women.

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Detailed Description

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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.

Conditions

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Osteoporosis Achlorhydria GERD Hip Fracture

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Experimental

Subjects will receive omeprazole 40 mg daily for 30 days

Group Type EXPERIMENTAL

Omeprazole

Intervention Type DRUG

40 mg po qAM one-half hour before breakfast for 30 days

Interventions

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Omeprazole

40 mg po qAM one-half hour before breakfast for 30 days

Intervention Type DRUG

Other Intervention Names

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Losec Prilosec

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes