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To Learn How Bone Structure and Bone Mass Change After Long-term PPI Use

NCT01306799 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 106

Last updated 2017-03-30

No results posted yet for this study

Summary

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.

Conditions

  • Barrett's Esophagus
  • Erosive Esophagitis
  • Gastroesophageal Reflux Disease(GERD)

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Pennsylvania

    lead OTHER

Principal Investigators

  • Yu-Xiao Yang, MD, MSCE · University of Pennsylvania

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01306799 on ClinicalTrials.gov