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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

June 4, 2010
January 25, 2013
October 2009
July 2010   (final data collection date for primary outcome measure)
changes in Parathyroid hormone levels [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
PTH levels at 3 months minus at baseline
changes in Parathyroid hormone levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01139645 on ClinicalTrials.gov Archive Site
  • 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
changes in 25-OH-Vit D, Osteocalcin, Crosslaps, Calcium, Ionized Calcium, Phosphorus, Albumin blood levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Effect of Proton Pump Inhibitors on Calcium and Bone Metabolism
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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Calcium Metabolism Disorders
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
  • Experimental: Proton Pump Inhibitors
    patients were started on Proton Pump inhibitors for 3 months (the whole duration of the study)
    Intervention: Drug: Rabeprazole or Esomeprazole or Lanzoprazole
  • 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Lebanon
 
NCT01139645
IM.AS1.24
Yes
Ala'a Sharara, American University of Beirut Medical Center
American University of Beirut Medical Center
AstraZeneca
Principal Investigator: Ala' I. Sharara, MD American University of Beirut Medical Center
American University of Beirut Medical Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP