The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism

Calcium Metabolism Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01139645
• Other study ID #: IM.AS1.24
• Status: Completed
• Phase: N/A
• First received: June 4, 2010
• Last updated: January 25, 2013
• Start date: October 2009
• Est. completion date: July 2010

Study information

• Verified date: January 2013
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lebanon: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Calcium Metabolism Disorders
• Metabolic Diseases

Intervention

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

Locations

Country	Name	City	State
Lebanon	American University of Beirut - Medical Center	Beirut

Sponsors (2)

Lead Sponsor	Collaborator
American University of Beirut Medical Center	AstraZeneca

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in Parathyroid hormone levels	PTH levels at 3 months minus at baseline	baseline and 3 months	No
Secondary	changes in 25-OH-Vitamin D blood levels	25-OH-Vitamin D blood levels at 3 months minus baseline	baseline and 3 months	No
Secondary	changes in osteocalcin levels in blood	osteocalcin levels at 3 months minus at baseline	baseline and 3 months	No
Secondary	changes in crosslaps levels in blood	crosslaps levels in blood at 3 months minus at baseline	baseline and 3 months	No
Secondary	changes in serum ionized calcium levels	serum ionized calcium levels at 3 months minus at baseline	baseline and 3 months	No