Achlorhydria, GERD, Hip Fracture, Osteoporosis
Conditions
Keywords
Calcium Absorption, Fractional Calcium Absorption, Omeprazole, Stable Calcium Isotopes, Proton Pump Inhibitor, Intestinal Absorption of Calcium
Brief summary
The purpose of this study is to measure the effect of omeprazole on intestinal calcium absorption in postmenopausal women.
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.
Interventions
DRUGOmeprazole
40 mg po qAM one-half hour before breakfast for 30 days
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
FEMALE
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intestinal Calcium Absorption From Baseline to One Month | change in calcium absorption from baseline to 1 month | percent calcium absorption |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Recruitment details
At least 5 years past onset of menopause; not taking proton pump inhibitors
Pre-assignment details
subjects completed a food diary
Participants by arm
| Arm | Count |
|---|---|
| Experimental Subjects will receive omeprazole 40 mg daily for 30 days | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 2 |
Baseline characteristics
| Characteristic | Experimental |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age Continuous | 58 years STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
Change in Intestinal Calcium Absorption From Baseline to One Month
percent calcium absorption
Time frame: change in calcium absorption from baseline to 1 month
Population: Subjects completing the measures of calcium absorption were included in the analysis of the primary outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Change in Intestinal Calcium Absorption From Baseline to One Month | 5 percent calcium absorption | Standard Deviation 10 |
Secondary
Change in Bone Resorption From Baseline to 1 Month
urine n-telopeptide (normalized to creatinine levels)
Time frame: change in bone resorption from baseline to 1 month
Population: 23 enrolled but two dropped from the study, leading to 21 subjects who completed all study visits
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Change in Bone Resorption From Baseline to 1 Month | 1.9 mcg/mmol creatinine | Standard Deviation 0.9 |