Does Omeprazole Decrease Intestinal Calcium Absorption?

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT00582972
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arm: 1
• Duration (Months): 35
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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

• Study Type: Interventional
• 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: Jan 1, 2008
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

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

Primary Outcome Measures

1. Change in Intestinal Calcium Absorption From Baseline to One Month [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 [change in bone resorption from baseline to 1 month]

   urine n-telopeptide (normalized to creatinine levels)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00582972
• Other Study ID Numbers: H-2007-0179; 07-1235-03
• First Posted: Dec 28, 2007
• Last Update Posted: Feb 15, 2013
• Last Verified: Feb 1, 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: Osteoporosis; Achlorhydria; Hip Fractures; Omeprazole

Study Results

Participant Flow

Recruitment Details	At least 5 years past onset of menopause; not taking proton pump inhibitors
Pre-assignment Detail	subjects completed a food diary

Arm/Group Title	Experimental
Arm/Group Description	Subjects will receive omeprazole 40 mg daily for 30 days
Period Title: Overall Study
STARTED	23
COMPLETED	21
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Experimental
Arm/Group Description	Subjects will receive omeprazole 40 mg daily for 30 days
Overall Participants	23
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	23 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58 (7)
Sex: Female, Male (Count of Participants)
Female	23 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	23 100%

Outcome Measures

1. Primary Outcome

Title	Change in Intestinal Calcium Absorption From Baseline to One Month
Description	percent calcium absorption
Time Frame	change in calcium absorption from baseline to 1 month

Outcome Measure Data

Analysis Population Description

Subjects completing the measures of calcium absorption were included in the analysis of the primary outcome.

Arm/Group Title	Experimental
Arm/Group Description	omeprazole 40 mg daily for 30 days
Measure Participants	21
Mean (Standard Deviation) [percent calcium absorption]	5 (10)

2. Secondary Outcome

Title	Change in Bone Resorption From Baseline to 1 Month
Description	urine n-telopeptide (normalized to creatinine levels)
Time Frame	change in bone resorption from baseline to 1 month

Outcome Measure Data

Analysis Population Description

23 enrolled but two dropped from the study, leading to 21 subjects who completed all study visits

Arm/Group Title	Experimental
Arm/Group Description	Subjects received omeprazole 40 mg daily for 30 days
Measure Participants	21
Mean (Standard Deviation) [mcg/mmol creatinine]	1.9 (0.9)

Adverse Events

Arm/Group Title	Experimental
Arm/Group Description	Subjects will receive omeprazole 40 mg daily for 30 days
All Cause Mortality
	Experimental
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Experimental
	Affected / at Risk (%)	# Events
Total	0/21 (0%)
Other (Not Including Serious) Adverse Events
	Experimental
	Affected / at Risk (%)	# Events
Total	0/21 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.