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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
58
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
American University of Beirut - Medical Center
Beirut, Lebanon
changes in Parathyroid hormone levels
PTH levels at 3 months minus at baseline
Time frame: baseline and 3 months
changes in 25-OH-Vitamin D blood levels
25-OH-Vitamin D blood levels at 3 months minus baseline
Time frame: baseline and 3 months
changes in osteocalcin levels in blood
osteocalcin levels at 3 months minus at baseline
Time frame: baseline and 3 months
changes in crosslaps levels in blood
crosslaps levels in blood at 3 months minus at baseline
Time frame: baseline and 3 months
changes in serum ionized calcium levels
serum ionized calcium levels at 3 months minus at baseline
Time frame: baseline and 3 months
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