Calcium Metabolism Disorders
Conditions
Keywords
Calcium, bone, metabolism, Proton Pump Inhibitors, Rabeprazole, Esomeprazole, Lanzoprazole, Vitamin D, bone and bones
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.
Interventions
DRUGRabeprazole or Esomeprazole or Lanzoprazole
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
Sponsors
AstraZeneca
American University of Beirut Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in Parathyroid hormone levels | baseline and 3 months | PTH levels at 3 months minus at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Lebanon
Outcome results
None listed