Clinical trial NCT01139645: The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism
Official title: The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism: A Prospective Single-Blind Matched Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Calcium Metabolism Disorders
Keywords: Calcium
bone
metabolism
Proton Pump Inhibitors
Rabeprazole
Esomeprazole
Lanzoprazole
Vitamin D
bone and bones
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2010-06-08
Enrollment: 58
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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.


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

Primary outcomes:
measure: changes in Parathyroid hormone levels
timeFrame: baseline and 3 months
Secondary outcomes:
measure: changes in 25-OH-Vitamin D blood levels
timeFrame: baseline and 3 months
measure: changes in osteocalcin levels in blood
timeFrame: baseline and 3 months
measure: changes in crosslaps levels in blood
timeFrame: baseline and 3 months
measure: changes in serum ionized calcium levels
timeFrame: baseline and 3 months
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut - Medical Center
Study officials:
affiliation: American University of Beirut Medical Center
name: Ala' I. Sharara, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sharara AI, El-Halabi MM, Ghaith OA, Habib RH, Mansour NM, Malli A, El Hajj-Fuleihan G. Proton pump inhibitors have no measurable effect on calcium and bone metabolism in healthy young males: a prospective matched controlled study. Metabolism. 2013 Apr;62(4):518-26. doi: 10.1016/j.metabol.2012.09.011. Epub 2012 Oct 24.