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To Learn How Bone Structure and Bone Mass Change After Long-term PPI Use (BE-CAST)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Pennsylvania.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01306799
First received: February 17, 2011
Last updated: November 17, 2011
Last verified: November 2011
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Chronic Proton Pump Inhibitor Therapy on Bone Mineral Density and Bone Structure in Mid to Late Adulthood

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Volumetric bone mineral density as measured by pQCT [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • measure PTH levels at each study visit [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    monitor change in PTH levels because long-term PPI therapy may have an affect on parathyroid glands, increasing parathyroid hormone (PTH) secretion.

  • measure vitamin B12 levels at each study visit [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    low B12 levels have been associated with reduced bone mineral density (BMD) as well osteoporotic fracture risk


Estimated Enrollment: 116
Study Start Date: January 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Barrett's Esophagus, Erosive Esophagitis, GERD

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  • Patients who either are starting or have been receiving long-term continuous PPI therapy for erosive esophagitis or Barrett's esophagus diagnosed within the past three years.
  • Patients who are starting PPI therapy for gastroesophageal reflux disease (GERD) and have shown a subjective improvement in symptoms within 4 weeks of starting therapy. This improvement will be assessed either through documentation in their medical record or through telephone interview with permission from their physician.
  • Patients who are starting PPI therapy for ulcer prophylaxis in a setting of chronic aspirin use.
  • Patients who are starting PPI therapy for extraesophageal manifestations of GERD.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01306799

Contacts
Contact: Theresa Alcorn 215-746-6151 thh@mail.med.upenn.edu
Contact: Harjeet Sembhi, MPH 215-746-6152 sembhi@mail.med.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Yu-Xiao Yang, MD, MSCE         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Yu-Xiao Yang, MD, MSCE University of Pennsylvania
  More Information

No publications provided

Responsible Party: Yu-Xiao Yang, MD, MSCE, FACP, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01306799     History of Changes
Other Study ID Numbers: 810599, 1R01AR057102-01
Study First Received: February 17, 2011
Last Updated: November 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Barrett's Esophagus
Erosive Esophagitis
Proton Pump Inhibitor (PPI)
Bone
Bone Density
GERD
ulcer prophylaxis

Additional relevant MeSH terms:
Barrett Esophagus
Esophagitis
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastroenteritis
Gastrointestinal Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2014