Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Does Omeprazole Decrease Intestinal Calcium Absorption?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00582972
Recruitment Status : Completed
First Posted : December 28, 2007
Results First Posted : January 21, 2013
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to measure the effect of omeprazole on intestinal calcium absorption in postmenopausal women.

Condition or disease Intervention/treatment Phase
Osteoporosis Achlorhydria GERD Hip Fracture Drug: Omeprazole Phase 4

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Does Omeprazole Decrease Intestinal Calcium Absorption?
Study Start Date : January 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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:
  • Losec
  • Prilosec


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in Intestinal Calcium Absorption From Baseline to One Month [ Time Frame: change in calcium absorption from baseline to 1 month ]
    percent calcium absorption


Secondary Outcome Measures :
  1. 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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00582972


Locations
Layout table for location information
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Layout table for investigator information
Principal Investigator: Karen E Hansen, MD Univeristy of Wisconsin School of Medicine and Public Health
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00582972    
Other Study ID Numbers: H-2007-0179
07-1235-03
First Posted: December 28, 2007    Key Record Dates
Results First Posted: January 21, 2013
Last Update Posted: February 15, 2013
Last Verified: February 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:
Layout table for MeSH terms
Osteoporosis
Achlorhydria
Hip Fractures
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
 Leg Injuries
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Acid-Base Imbalance
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action