OsteoporosisPhase 4NCT00582972
Does Omeprazole Decrease Intestinal Calcium Absorption?
A Phase 4 study testing Omeprazole in people with Osteoporosis and Achlorhydria, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to measure the effect of omeprazole on intestinal calcium absorption in postmenopausal women. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Achlorhydria, GERD
- What is being tested?
- Omeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women at least 5 years past menopause, defined as the last date of menses
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
The purpose of this study is to measure the effect of omeprazole on intestinal calcium absorption in postmenopausal women.
Read the 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.
- Conditions
- Osteoporosis, Achlorhydria, GERD, Hip Fracture
- Being tested
- Omeprazole
- Keywords
- Calcium Absorption, Fractional Calcium Absorption, Omeprazole, Stable Calcium Isotopes, Proton Pump Inhibitor, Intestinal Absorption of Calcium
- Medical subject headings
- Osteoporosis, Achlorhydria, Gastroesophageal Reflux, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Also called Losec, Prilosec
40 mg po qAM one-half hour before breakfast for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Subjects will receive omeprazole 40 mg daily for 30 days Receives: Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intestinal Calcium Absorption From Baseline to One Month
percent calcium absorption
Measured: change in calcium absorption from baseline to 1 month
Secondary outcomes (1)
Change in Bone Resorption From Baseline to 1 Month
urine n-telopeptide (normalized to creatinine levels)
Measured: change in bone resorption from baseline to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen E Hansen, MD, Principal investigator, Univeristy of Wisconsin School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00582972
- Sponsor's protocol ID
- H-2007-0179
- Other IDs
- 07-1235-03
- Status last verified
- Feb 2013
- First submitted
- 19 Dec 2007
- Last updated
- 15 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 20578215Jones 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.
PubMed 21347742
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Omeprazole Decrease Intestinal Calcium Absorption?
- ClinicalTrials.gov ID
- NCT00582972
- Acronym / sponsor ID
- H-2007-0179
- Conditions
- Osteoporosis, Achlorhydria, GERD, Hip Fracture
- Keywords
- Calcium Absorption, Fractional Calcium Absorption, Omeprazole, Stable Calcium Isotopes, Proton Pump Inhibitor, Intestinal Absorption of Calcium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Dec 2007 (estimated)
- Results
- Posted 21 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: OmeprazoleSubjects will receive omeprazole 40 mg daily for 30 days |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women at least 5 years past menopause, defined as the last date of menses
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmeprazoleAlso: Losec, Prilosec40 mg po qAM one-half hour before breakfast for 30 days | Drug | Experimental |
Primary outcome
Change in Intestinal Calcium Absorption From Baseline to One Month
Time frame: change in calcium absorption from baseline to 1 month
percent calcium absorption
1 secondary outcome
Change in Bone Resorption From Baseline to 1 Month
Time frame: change in bone resorption from baseline to 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20578215Hansen 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.
- Results publication: PubMed 21347742Jones 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen E Hansen, MD principal investigator
Univeristy of Wisconsin School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omeprazole in people with Osteoporosis and Achlorhydria, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intestinal Calcium Absorption From Baseline to One Month (time frame: change in calcium absorption from baseline to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00582972, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2013.