The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism
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|ClinicalTrials.gov Identifier: NCT01139645|
Recruitment Status : Completed
First Posted : June 8, 2010
Last Update Posted : January 28, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Calcium Metabolism Disorders||Drug: Rabeprazole or Esomeprazole or Lanzoprazole||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism: A Prospective Single-Blind Matched Controlled Study|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||July 2010|
Experimental: Proton Pump Inhibitors
patients were started on Proton Pump inhibitors for 3 months (the whole duration of the study)
Drug: Rabeprazole 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
No Intervention: No Proton Pump Inhibitors
patients are not taking any Proton Pump Inhibitor, and they are matched by age to patients in the experimental group.
- changes in Parathyroid hormone levels [ Time Frame: baseline and 3 months ]PTH levels at 3 months minus at baseline
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01139645
|American University of Beirut - Medical Center|
|Principal Investigator:||Ala' I. Sharara, MD||American University of Beirut Medical Center|