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The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Ala'a Sharara, American University of Beirut Medical Center
ClinicalTrials.gov Identifier:
NCT01139645
First received: June 4, 2010
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Calcium Metabolism Disorders
 Drug: Rabeprazole or Esomeprazole or Lanzoprazole

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism: A Prospective Single-Blind Matched Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by American University of Beirut Medical Center:

Primary Outcome Measures:
  • changes in Parathyroid hormone levels [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    PTH levels at 3 months minus at baseline


Secondary Outcome Measures:
  • changes in 25-OH-Vitamin D blood levels [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    25-OH-Vitamin D blood levels at 3 months minus baseline

  • changes in osteocalcin levels in blood [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    osteocalcin levels at 3 months minus at baseline

  • changes in crosslaps levels in blood [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    crosslaps levels in blood at 3 months minus at baseline

  • changes in serum ionized calcium levels [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    serum ionized calcium levels at 3 months minus at baseline


Enrollment: 58
Study Start Date: October 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139645

Locations
Lebanon
American University of Beirut - Medical Center
Beirut, Lebanon
Sponsors and Collaborators
American University of Beirut Medical Center
AstraZeneca
Investigators
Principal Investigator: Ala' I. Sharara, MD American University of Beirut Medical Center
  More Information

No publications provided by American University of Beirut Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ala'a Sharara, Professor, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT01139645     History of Changes
Other Study ID Numbers: IM.AS1.24
Study First Received: June 4, 2010
Last Updated: January 25, 2013
Health Authority: Lebanon: Institutional Review Board

Keywords provided by American University of Beirut Medical Center:
Calcium
bone
metabolism
Proton Pump Inhibitors
Rabeprazole
 Esomeprazole
Lanzoprazole
Vitamin D
bone and bones

Additional relevant MeSH terms:
Calcium Metabolism Disorders
Metabolic Diseases
Omeprazole
Lansoprazole
Rabeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
 Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 23, 2013