The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism

American University of Beirut Medical Center

Status: Completed

Conditions: Calcium Metabolism Disorders

Treatments: Drug: Rabeprazole or Esomeprazole or Lanzoprazole

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01139645

IM.AS1.24

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

58 participants in 2 patient groups

Proton Pump Inhibitors

Experimental group

Description:

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

Treatment:

Drug: Rabeprazole or Esomeprazole or Lanzoprazole

No Proton Pump Inhibitors

No Intervention group

Description:

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