To Learn How Bone Structure and Bone Mass Change After Long-term PPI Use
| Status: | Completed |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease , Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 40 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | January 2010 |
| End Date: | April 2015 |
Effect of Chronic Proton Pump Inhibitor Therapy on Bone Mineral Density and Bone Structure in Mid to Late Adulthood
Patients with severe acid reflux and/or Barrett's esophagus are recommended to take Proton
pump inhibitors (PPIs)indefinitely to prevent complications such as strictures or the
development of a type of esophageal cancer. Recently, some studies suggested that taking
these medications on a long-term basis may affect the bone. Therefore, it is important to
learn whether these medications may lead to accelerated bone loss so that effective
preventive measures can be developed for patients who require these medications for
acid-related conditions. Several studies reported that patients receiving PPIs for many
years may have increased risk of hip fractures. However, it is unclear whether this is
because the PPIs cause reduced bone density or whether the increased risk of fractures has
nothing to do with PPIs and is because patients who require PPIs have other illnesses that
cause the increased fractures. The purpose of the study is to learn how bone structure and
bone mass change after long-term PPI use.
pump inhibitors (PPIs)indefinitely to prevent complications such as strictures or the
development of a type of esophageal cancer. Recently, some studies suggested that taking
these medications on a long-term basis may affect the bone. Therefore, it is important to
learn whether these medications may lead to accelerated bone loss so that effective
preventive measures can be developed for patients who require these medications for
acid-related conditions. Several studies reported that patients receiving PPIs for many
years may have increased risk of hip fractures. However, it is unclear whether this is
because the PPIs cause reduced bone density or whether the increased risk of fractures has
nothing to do with PPIs and is because patients who require PPIs have other illnesses that
cause the increased fractures. The purpose of the study is to learn how bone structure and
bone mass change after long-term PPI use.
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.
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
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