To Learn How Bone Structure and Bone Mass Change After Long-term PPI Use
Completed
Conditions studied: Barrett's Esophagus, Erosive Esophagitis, Gastroesophageal Reflux Disease(GERD)
In brief
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.
Key facts
- Study ID
- NCT01306799
- Run by
- University of Pennsylvania
- People needed
- 106
- Starts
- 2010-01-01
- Expected to finish
- 2015-04-01
- Last updated by the study team
- 2017-03-30
Who can join
Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Pre-menopausal women
- men under 40 years old
Where it is running
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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