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| ID | Type | Description | Link |
|---|---|---|---|
| 07-1235-03 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Subjects will receive omeprazole 40 mg daily for 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole | Drug | 40 mg po qAM one-half hour before breakfast for 30 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intestinal Calcium Absorption From Baseline to One Month | percent calcium absorption | change in calcium absorption from baseline to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen E Hansen, MD | Univeristy of Wisconsin School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20578215 | Result | 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. | |
| 21347742 | Result | 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. |
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subjects completed a food diary
At least 5 years past onset of menopause; not taking proton pump inhibitors
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | Subjects will receive omeprazole 40 mg daily for 30 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Subjects will receive omeprazole 40 mg daily for 30 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Intestinal Calcium Absorption From Baseline to One Month | percent calcium absorption | Subjects completing the measures of calcium absorption were included in the analysis of the primary outcome. | Posted | Mean | Standard Deviation | percent calcium absorption | change in calcium absorption from baseline to 1 month |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental | Subjects will receive omeprazole 40 mg daily for 30 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen Hansen | University of Wisconsin | 608-263-3457 | keh@medicine.wisc.edu |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D000126 | Achlorhydria |
| D005764 | Gastroesophageal Reflux |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Change in Bone Resorption From Baseline to 1 Month | urine n-telopeptide (normalized to creatinine levels) | 23 enrolled but two dropped from the study, leading to 21 subjects who completed all study visits | Posted | Mean | Standard Deviation | mcg/mmol creatinine | change in bone resorption from baseline to 1 month |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D000137 | Acid-Base Imbalance |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |