The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism

NCT01139645 | Completed DMC

• 1 other identifier: IM.AS1.24
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Calcium Metabolism Disorders

Keywords

Calcium; bone; metabolism; Proton Pump Inhibitors; Rabeprazole; Esomeprazole; Lanzoprazole; Vitamin D; bone and bones

Outcome Measures

Primary Outcomes (1)

• changes in Parathyroid hormone levels

  PTH levels at 3 months minus at baseline

  baseline and 3 months

Secondary Outcomes (4)

• changes in 25-OH-Vitamin D blood levels

  baseline and 3 months

• changes in osteocalcin levels in blood

  baseline and 3 months

• changes in crosslaps levels in blood

  baseline and 3 months

• changes in serum ionized calcium levels

  baseline and 3 months

Study Arms (2)

Proton Pump Inhibitors

EXPERIMENTAL

patients were started on Proton Pump inhibitors for 3 months (the whole duration of the study)

Drug: Rabeprazole or Esomeprazole or Lanzoprazole

No Proton Pump Inhibitors

NO INTERVENTION

patients are not taking any Proton Pump Inhibitor, and they are matched by age to patients in the experimental group.

Interventions

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

Proton Pump Inhibitors

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males aged 18-50 years
• Healthy (or healthy with heartburn only)

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead
• AstraZeneca: collaborator

Study Sites (1)

American University of Beirut - Medical Center

Beirut, Lebanon

Location

Related Publications (1)

• 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.

  PMID: 23102518 DERIVED

MeSH Terms

Conditions

Calcium Metabolism Disorders

Interventions

Rabeprazole; Esomeprazole

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Omeprazole

Study Officials

• Ala' I. Sharara, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: June 8, 2010
• Study Start: October 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: January 28, 2013

Record last verified: 2013-01

Locations

LE (1)