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The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism

NCT01139645 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2013-01-28

No results posted yet for this study

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 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

Interventions

DRUG

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • American University of Beirut Medical Center

    lead OTHER

Principal Investigators

  • Ala' I. Sharara, MD · American University of Beirut Medical Center

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Lebanon

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01139645 on ClinicalTrials.gov