The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Calcium Metabolism Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Proton Pump Inhibitors

patients were started on Proton Pump inhibitors for 3 months (the whole duration of the study)

Group Type EXPERIMENTAL

Rabeprazole or Esomeprazole or Lanzoprazole

Intervention Type DRUG

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

No Proton Pump Inhibitors

patients are not taking any Proton Pump Inhibitor, and they are matched by age to patients in the experimental group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Rabeprazole or Esomeprazole or Lanzoprazole

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males aged 18-50 years
* Healthy (or healthy with heartburn only)

Exclusion Criteria

* 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
* Intake of the following medications:

* Vitamin D or calcium supplements
* PPIs or H2 receptor antagonists within the past year
* One-Alpha
* Anticonvulsants
* Glucocorticoids

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes