The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism

January 25, 2013 updated by: Ala'a Sharara, American University of Beirut Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Beirut, Lebanon
        • American University of Beirut - Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in Parathyroid hormone levels
Time Frame: baseline and 3 months
PTH levels at 3 months minus at baseline
baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline and 3 months
changes in osteocalcin levels in blood
Time Frame: baseline and 3 months
osteocalcin levels at 3 months minus at baseline
baseline and 3 months
changes in crosslaps levels in blood
Time Frame: baseline and 3 months
crosslaps levels in blood at 3 months minus at baseline
baseline and 3 months
changes in serum ionized calcium levels
Time Frame: baseline and 3 months
serum ionized calcium levels at 3 months minus at baseline
baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American University of Beirut Medical Center

Collaborators

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

June 4, 2010

First Submitted That Met QC Criteria

June 7, 2010

First Posted (ESTIMATE)

June 8, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 28, 2013

Last Update Submitted That Met QC Criteria

January 25, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM.AS1.24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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