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Effect of Chronic Proton Pump Inhibitor Therapy on Bone Mineral Density and Bone Structure in Mid to Late Adulthood

40 Years
75 Years
Open (Enrolling)
Barrett's Esophagus, Erosive Esophagitis, Gastroesophageal Reflux Disease(GERD)

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Trial Information

Effect of Chronic Proton Pump Inhibitor Therapy on Bone Mineral Density and Bone Structure in Mid to Late Adulthood

Proton pump inhibitors (PPIs) are among the most widely used medications. It is becoming
increasingly common for patients to take these potent acid suppressants on a long-term and
continuous basis for erosive esophagitis, Barrett's esophagus and protection against
nonsteroidal anti-inflammatory drug-related gastropathy. PPI therapy leads to elevated serum
gastrin levels and may impair the absorption of calcium and food-bound vitamin B12.
PPI-induced hypergastrinemia has a direct trophic effect on the parathyroid glands, leading
to parathyroid hyperplasia, increased parathyroid hormone secretion and bone loss.
Furthermore, both calcium malabsorption and vitamin B12 deficiency are associated with
reduced bone mineral density (BMD) and increased osteoporotic fracture risk. Consistent with
these data, recent studies revealed a positive association between PPI therapy and the risk
of osteoporotic fractures. Peripheral quantitative computed tomography (pQCT) can provide a
three-dimensional structural analysis of trabecular and cortical volumetric BMD (vBMD) and
dimensions. These data are imperative for a valid assessment of the effect of chronic PPI
therapy on bone strength. The investigators hypothesize that PPI therapy leads to decreased
cortical and trabecular vBMD, cortical dimensions and bone strength.

Inclusion Criteria:

- women between 50 to 75 years old

- men between 40 to 75 years old

- Barrett's esophagus and Erosive esophagitis diagnosed within the past three years,
GERD or Acid Reflux, taking chronic aspirin

- Starting long-term PPI therapy or currently on long-term PPI therapy

Exclusion Criteria:

- Pre-menopausal women

- men under 40 years old

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Volumetric bone mineral density as measured by pQCT

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Yu-Xiao Yang, MD, MSCE

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania


United States: Institutional Review Board

Study ID:




Start Date:

January 2010

Completion Date:

November 2014

Related Keywords:

  • Barrett's Esophagus
  • Erosive Esophagitis
  • Gastroesophageal Reflux Disease(GERD)
  • Barrett's Esophagus
  • Erosive Esophagitis
  • Proton Pump Inhibitor (PPI)
  • Bone
  • Bone Density
  • GERD
  • ulcer prophylaxis
  • Barrett Esophagus
  • Esophagitis
  • Gastroesophageal Reflux



University of Pennsylvania Philadelphia, Pennsylvania  19104