Does Omeprazole Decrease Intestinal Calcium Absorption?

Osteoporosis Clinical Trial

Official title:

Does Omeprazole Decrease Intestinal Calcium Absorption?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00582972
• Other study ID #: H-2007-0179
• Secondary ID: 07-1235-03
• Status: Completed
• Phase: Phase 4
• First received: December 19, 2007
• Last updated: February 14, 2013
• Start date: January 2008
• Est. completion date: December 2010

Study information

• Verified date: February 2013
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Achlorhydria
• GERD
• Hip Fracture
• Hip Fractures
• Osteoporosis

Intervention

Drug:
• Omeprazole
40 mg po qAM one-half hour before breakfast for 30 days

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (2)

Hansen KE, Jones AN, Lindstrom MJ, Davis LA, Ziegler TE, Penniston KL, Alvig AL, Shafer MM. Do proton pump inhibitors decrease calcium absorption? J Bone Miner Res. 2010 Dec;25(12):2786-95. doi: 10.1002/jbmr.166. Epub 2010 Jun 24. Erratum in: J Bone Miner — View Citation

Jones AN, Shafer MM, Keuler NS, Crone EM, Hansen KE. Fasting and postprandial spot urine calcium-to-creatinine ratios do not detect hypercalciuria. Osteoporos Int. 2012 Feb;23(2):553-62. doi: 10.1007/s00198-011-1580-7. Epub 2011 Feb 24. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Intestinal Calcium Absorption From Baseline to One Month	percent calcium absorption	change in calcium absorption from baseline to 1 month	Yes
Secondary	Change in Bone Resorption From Baseline to 1 Month	urine n-telopeptide (normalized to creatinine levels)	change in bone resorption from baseline to 1 month	Yes