A Phase 4 interventional study of Omeprazole in Osteoporosis, Achlorhydria and GERD, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-15.
Sponsored by University of Wisconsin, Madison · Phase 4 and Interventional
The purpose of this study is to measure the effect of omeprazole on intestinal calcium absorption in postmenopausal women.
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.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 23 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will receive omeprazole 40 mg daily for 30 days
Drug: Omeprazole
40 mg po qAM one-half hour before breakfast for 30 days
Also known as: Losec, Prilosec
Change in Intestinal Calcium Absorption From Baseline to One Month
percent calcium absorption
Time frame: change in calcium absorption from baseline to 1 month
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
At least 5 years past onset of menopause; not taking proton pump inhibitors
| Milestone | Experimental |
|---|---|
| Started | 23 |
| Completed | 21 |
| Not completed | 2 |
| Withdrew: Protocol violation | 2 |
percent calcium absorption
| percent calcium absorption | Experimental |
|---|---|
| Change in Intestinal Calcium Absorption From Baseline to One Month | 5 ± 10 |
urine n-telopeptide (normalized to creatinine levels)
| mcg/mmol creatinine | Experimental |
|---|---|
| Change in Bone Resorption From Baseline to 1 Month | 1.9 ± 0.9 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental | — | 0/21 (0%) | 0/21 (0%) |
| Age, Categorical(Participants) | Experimental |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 23 |
| >=65 years | 0 |
| Age Continuous(years) | Experimental |
|---|---|
| Mean | 58 ± 7 |
| Sex: Female, Male(Participants) | Experimental |
|---|---|
| Female | 23 |
| Male | 0 |
| Region of Enrollment(participants) | Experimental |
|---|---|
| United States | 23 |
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Madison