The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: American University of Beirut Medical Center
• Collaborator: AstraZeneca
• Treatments: Calcium, Dietary; Esomeprazole; Proton Pump Inhibitors; Rabeprazole

Criteria

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