Ignite Creation Date:
2024-05-05 @ 10:34 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01139645
Status:
COMPLETED
Last Update Posted:
2013-01-28
First Post:
2010-06-04
Brief Title:
The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism
Sponsor:
American University of Beirut Medical Center
Organization:
American University of Beirut Medical Center
Study Overview
Official Title:
The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism A Prospective Single-Blind Matched Controlled Study
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None