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Completed

NCT Number: NCT01139645

The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism

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.

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Key information

Conditions

Calcium Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

American University of Beirut - Medical Center

Beirut, Lebanon

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rabeprazole or Esomeprazole or Lanzoprazole

Drug

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

Primary outcomes

  1. changes in Parathyroid hormone levels

    Time frame: baseline and 3 months

    PTH levels at 3 months minus at baseline

Secondary outcomes

  1. 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

  2. changes in osteocalcin levels in blood

    Time frame: baseline and 3 months

    osteocalcin levels at 3 months minus at baseline

  3. changes in crosslaps levels in blood

    Time frame: baseline and 3 months

    crosslaps levels in blood at 3 months minus at baseline

  4. changes in serum ionized calcium levels

    Time frame: baseline and 3 months

    serum ionized calcium levels at 3 months minus at baseline

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 8, 2010
Registry last updated
Jan 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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