Calcium Metabolism DisordersNCT01139645
The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism
A study testing Rabeprazole or Esomeprazole or Lanzoprazole in people with Calcium Metabolism Disorders, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
This prospective, single-blind, matched controlled study aims to evaluate the effect of proton pump inhibitors on biochemical markers of calcium and bone metabolism in an effort to establish additional biological plausibility for the apparent association between proton pump inhibitors (PPIs) and osteoporosis-related… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Calcium Metabolism Disorders
- What is being tested?
- Rabeprazole or Esomeprazole or Lanzoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteLebanon
- Study dates
- Oct 2009to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males aged 18-50 years
- Healthy (or healthy with heartburn only)
Who cannot join
- Female gender
- Previous allergy to PPI
- Regular beach seekers (more than once a week)
- Intestinal disease
- Recent fracture (within the past six months)
- Kidney stones
Show all 12Show fewer
- Intake of the following medications:
- Vitamin D or calcium supplements
- PPIs or H2 receptor antagonists within the past year
- One-Alpha
- Anticonvulsants
- Glucocorticoids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism: A Prospective Single-Blind Matched Controlled Study
This prospective, single-blind, matched controlled study aims to evaluate the effect of proton pump inhibitors on biochemical markers of calcium and bone metabolism in an effort to establish additional biological plausibility for the apparent association between proton pump inhibitors (PPIs) and osteoporosis-related fractures.
Young males (age 18-45 years), who are either healthy volunteers, or who complain of daily or frequent heartburn but are otherwise healthy, will be recruited and enrolled in the study. Patients with heartburn will be assigned to the intervention group and will be assigned to take a PPI for three months. Healthy volunteers will be matched by age to patients in the intervention group and will act as the control group. 70 patients will be enrolled in total. Blood studies for all subjects will be taken at 0, 1 and 3 months to test for various biochemical markers of calcium and bone metabolism, which act as surrogate markers of calcium absorption and bone remodeling.
Levels of biochemical markers in the two groups will be compared using two-way analysis of variance (ANOVA). Changes in biochemical parameters within a group will be assessed using repeated measures ANOVA.
- Conditions
- Calcium Metabolism Disorders
- Being tested
- Rabeprazole or Esomeprazole or Lanzoprazole
- Keywords
- Calcium, bone, metabolism, Proton Pump Inhibitors, Rabeprazole, Esomeprazole, Lanzoprazole, Vitamin D, bone and bones
- Medical subject headings
- Calcium Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabeprazole or Esomeprazole or LanzoprazoleDrug
1/3 of the patients are taking Pariet (Rabeprazole) 20 mg once daily 1/3 of the patients are taking Nexium (Esomeprazole) 40 mg once daily 1/3 of the patients are taking Lanzor (Lanzoprazole) 30 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Proton Pump Inhibitors | Experimental | patients were started on Proton Pump inhibitors for 3 months (the whole duration of the study) Receives: Drug: Rabeprazole or Esomeprazole or Lanzoprazole |
| No Proton Pump Inhibitors | No intervention | patients are not taking any Proton Pump Inhibitor, and they are matched by age to patients in the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in Parathyroid hormone levels
PTH levels at 3 months minus at baseline
Measured: baseline and 3 months
Secondary outcomes (4)
changes in 25-OH-Vitamin D blood levels
25-OH-Vitamin D blood levels at 3 months minus baseline
Measured: baseline and 3 months
changes in osteocalcin levels in blood
osteocalcin levels at 3 months minus at baseline
Measured: baseline and 3 months
changes in crosslaps levels in blood
crosslaps levels in blood at 3 months minus at baseline
Measured: baseline and 3 months
changes in serum ionized calcium levels
serum ionized calcium levels at 3 months minus at baseline
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startOct 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Calcium Metabolism DisordersStudies 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 N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Ala'a Sharara, American University of Beirut Medical Center
- Investigators
- Ala' I. Sharara, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139645
- Sponsor's protocol ID
- IM.AS1.24
- Status last verified
- Jan 2013
- First submitted
- 4 Jun 2010
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sharara AI, El-Halabi MM, Ghaith OA, Habib RH, Mansour NM, Malli A, El Hajj-Fuleihan G. Proton pump inhibitors have no measurable effect on calcium and bone metabolism in healthy young males: a prospective matched controlled study. Metabolism. 2013 Apr;62(4):518-26. doi: 10.1016/j.metabol.2012.09.011. Epub 2012 Oct 24.
PubMed 23102518
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism: A Prospective Single-Blind Matched Controlled Study
- ClinicalTrials.gov ID
- NCT01139645
- Acronym / sponsor ID
- IM.AS1.24
- Conditions
- Calcium Metabolism Disorders
- Keywords
- Calcium, bone, metabolism, Proton Pump Inhibitors, Rabeprazole, Esomeprazole, Lanzoprazole, Vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Oct 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 8 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, single-blind, matched controlled study aims to evaluate the effect of proton pump inhibitors on biochemical markers of calcium and bone metabolism in an effort to establish additional biological plausibility for the apparent association between proton pump inhibitors (PPIs) and osteoporosis-related fractures.
Young males (age 18-45 years), who are either healthy volunteers, or who complain of daily or frequent heartburn but are otherwise healthy, will be recruited and enrolled in the study. Patients with heartburn will be assigned to the intervention group and will be assigned to take a PPI for three months. Healthy volunteers will be matched by age to patients in the intervention group and will act as the control group. 70 patients will be enrolled in total. Blood studies for all subjects will be taken at 0, 1 and 3 months to test for various biochemical markers of calcium and bone metabolism, which act as surrogate markers of calcium absorption and bone remodeling.
Levels of biochemical markers in the two groups will be compared using two-way analysis of variance (ANOVA). Changes in biochemical parameters within a group will be assessed using repeated measures ANOVA.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proton Pump Inhibitors | Experimental | Drug: Rabeprazole or Esomeprazole or Lanzoprazolepatients were started on Proton Pump inhibitors for 3 months (the whole duration of the study) |
| No Proton Pump Inhibitors | No intervention | –patients are not taking any Proton Pump Inhibitor, and they are matched by age to patients in the experimental group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Males aged 18-50 years
- Healthy (or healthy with heartburn only)
Key exclusion criteria (12 listed)
- Female gender
- Previous allergy to PPI
- Regular beach seekers (more than once a week)
- Intestinal disease
- Recent fracture (within the past six months)
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 |
|---|---|---|
| Rabeprazole or Esomeprazole or Lanzoprazole1/3 of the patients are taking Pariet (Rabeprazole) 20 mg once daily 1/3 of the patients are taking Nexium (Esomeprazole) 40 mg once daily 1/3 of the patients are taking Lanzor (Lanzoprazole) 30 mg once daily | Drug | Proton Pump Inhibitors |
Primary outcome
changes in Parathyroid hormone levels
Time frame: baseline and 3 months
PTH levels at 3 months minus at baseline
4 secondary outcomes
changes in 25-OH-Vitamin D blood levels
Time frame: baseline and 3 months
changes in osteocalcin levels in blood
Time frame: baseline and 3 months
changes in crosslaps levels in blood
Time frame: baseline and 3 months
changes in serum ionized calcium levels
Time frame: baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
- Derived from this study: PubMed 23102518Sharara AI, El-Halabi MM, Ghaith OA, Habib RH, Mansour NM, Malli A, El Hajj-Fuleihan G. Proton pump inhibitors have no measurable effect on calcium and bone metabolism in healthy young males: a prospective matched controlled study. Metabolism. 2013 Apr;62(4):518-26. doi: 10.1016/j.metabol.2012.09.011. Epub 2012 Oct 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.
Ala' I. Sharara, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rabeprazole or Esomeprazole or Lanzoprazole in people with Calcium Metabolism Disorders, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 2 inclusion and 12 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 28 Jan 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 Lebanon. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
changes in Parathyroid hormone levels (time frame: baseline and 3 months). 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 NCT01139645, which also lists 1 linked publication.
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 28 Jan 2013.