The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism

Not Applicable

Completed

• Conditions: Calcium Metabolism Disorders
• Interventions: Drug: Rabeprazole or Esomeprazole or Lanzoprazole

• Registration Number: NCT01139645
• Lead Sponsor: American University of Beirut Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-06-04
• Study First Submitted QC: 2010-06-07
• Study First Posted: 2010-06-08
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-25
• Last Update Posted: 2013-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proton Pump Inhibitors	Rabeprazole or Esomeprazole or Lanzoprazole	patients were started on Proton Pump inhibitors for 3 months (the whole duration of the study)

Primary Outcome Measures

Name	Time	Method
changes in Parathyroid hormone levels	baseline and 3 months	PTH levels at 3 months minus at baseline

Secondary Outcome Measures

Name	Time	Method
changes in 25-OH-Vitamin D blood levels	baseline and 3 months	25-OH-Vitamin D blood levels at 3 months minus baseline
changes in osteocalcin levels in blood	baseline and 3 months	osteocalcin levels at 3 months minus at baseline
changes in crosslaps levels in blood	baseline and 3 months	crosslaps levels in blood at 3 months minus at baseline
changes in serum ionized calcium levels	baseline and 3 months	serum ionized calcium levels at 3 months minus at baseline

Trial Locations

Locations (1)

American University of Beirut - Medical Center; 🇱🇧 Beirut, Lebanon