Does Omeprazole Decrease Intestinal Calcium Absorption? - Full Text View

Sponsor:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00582972

Purpose

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.

Condition	Intervention	Phase
Osteoporosis Achlorhydria GERD Hip Fracture	Drug: Omeprazole	Phase IV

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment
Official Title:	Does Omeprazole Decrease Intestinal Calcium Absorption?

Resource links provided by NLM:

MedlinePlus related topics: Calcium Fractures Hip Injuries and Disorders Hip Replacement Osteoporosis

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium Calcium gluconate

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

Change in intestinal calcium absorption after one month of omeprazole therapy [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Enrollment:	21
Study Start Date:	January 2008
Estimated 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

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582972

Locations

United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator:

Karen E Hansen, MD

Univeristy of Wisconsin School of Medicine and Public Health

More Information

No publications provided

Responsible Party:	University of Wisconsin School of Medicine and Public Health ( Karen Hansen, MD )
Study ID Numbers:	H-2007-0179, 07-1235-03
Study First Received:	December 19, 2007
Last Updated:	February 3, 2010
ClinicalTrials.gov Identifier:	NCT00582972 History of Changes
Health Authority:	United States: Institutional Review Board

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:

Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Fractures, Bone
Disorders of Environmental Origin
Omeprazole
Bone Diseases
Hip Fractures
Femoral Fractures
Stomach Diseases
Musculoskeletal Diseases
Achlorhydria
Therapeutic Uses
Anti-Ulcer Agents

Metabolic Diseases
Wounds and Injuries
Gastrointestinal Agents
Osteoporosis
Bone Diseases, Metabolic
Enzyme Inhibitors
Hip Injuries
Acid-Base Imbalance
Pharmacologic Actions
Digestive System Diseases
Osteoporosis, Postmenopausal
Leg Injuries

ClinicalTrials.gov processed this record on February 08, 2010