The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism

Study Overview
=================
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.

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

Conditions
-----------------
Calcium Metabolism Disorders

Intervention / Treatment
-----------------
* Drug: Rabeprazole or Esomeprazole or Lanzoprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proton Pump Inhibitors<br>patients were started on Proton Pump inhibitors for 3 months (the whole duration of the study) | Drug: Rabeprazole or Esomeprazole or Lanzoprazole<br>* 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<br>|
| No Intervention: No Proton Pump Inhibitors<br>patients are not taking any Proton Pump Inhibitor, and they are matched by age to patients in the experimental group. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in Parathyroid hormone levels | PTH levels at 3 months minus at baseline | baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in 25-OH-Vitamin D blood levels | 25-OH-Vitamin D blood levels at 3 months minus baseline | baseline and 3 months | 
| changes in osteocalcin levels in blood | osteocalcin levels at 3 months minus at baseline | baseline and 3 months | 
| changes in crosslaps levels in blood | crosslaps levels in blood at 3 months minus at baseline | baseline and 3 months | 
| changes in serum ionized calcium levels | serum ionized calcium levels at 3 months minus at baseline | baseline and 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Calcium, bone, metabolism, Proton Pump Inhibitors, Rabeprazole, Esomeprazole, Lanzoprazole, Vitamin D, bone and bones