Clinical Trial: The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism: A Prospective Single-Blind Matched Controlled Study

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 Summary:
Sponsor: American University of Beirut Medical Center

Current Primary Outcome: changes in Parathyroid hormone levels [ Time Frame: baseline and 3 months ]

PTH levels at 3 months minus at baseline


Original Primary Outcome: changes in Parathyroid hormone levels [ Time Frame: 3 months ]

Current Secondary Outcome:

  • changes in 25-OH-Vitamin D blood levels [ Time Frame: baseline and 3 months ]
    25-OH-Vitamin D blood levels at 3 months minus baseline
  • changes in osteocalcin levels in blood [ Time Frame: baseline and 3 months ]
    osteocalcin levels at 3 months minus at baseline
  • changes in crosslaps levels in blood [ Time Frame: baseline and 3 months ]
    crosslaps levels in blood at 3 months minus at baseline
  • changes in serum ionized calcium levels [ Time Frame: baseline and 3 months ]
    serum ionized calcium levels at 3 months minus at baseline


Original Secondary Outcome: changes in 25-OH-Vit D, Osteocalcin, Crosslaps, Calcium, Ionized Calcium, Phosphorus, Albumin blood levels [ Time Frame: 3 months ]

Information By: American University of Beirut Medical Center

Dates:
Date Received: June 4, 2010
Date Started: October 2009
Date Completion:
Last Updated: January 25, 2013
Last Verified: January 2013