Barrett's EsophagusBE-CASTNCT01306799
To Learn How Bone Structure and Bone Mass Change After Long-term PPI Use
An observational study of Barrett's Esophagus and Erosive Esophagitis, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Barrett's Esophagus, Erosive Esophagitis, Gastroesophageal Reflux Disease(GERD)
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Pre-menopausal women
- men under 40 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Keywords
- Barrett's Esophagus, Erosive Esophagitis, Proton Pump Inhibitor (PPI), Bone, Bone Density, GERD, ulcer prophylaxis
- Medical subject headings
- Barrett Esophagus, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Barrett's Esophagus, Erosive Esophagitis, GERD | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric bone mineral density as measured by pQCT
Measured: 3 years
Secondary outcomes (2)
measure PTH levels at each study visit
monitor change in PTH levels because long-term PPI therapy may have an affect on parathyroid glands, increasing parathyroid hormone (PTH) secretion.
Measured: 3 years
measure vitamin B12 levels at each study visit
low B12 levels have been associated with reduced bone mineral density (BMD) as well osteoporotic fracture risk
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startJan 2010
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Yu-Xiao Yang, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306799
- Sponsor's protocol ID
- 810599
- Other IDs
- 1R01AR057102-01
- Acronym
- BE-CAST
- Status last verified
- Mar 2017
- First submitted
- 17 Feb 2011
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chronic Proton Pump Inhibitor Therapy on Bone Mineral Density and Bone Structure in Mid to Late Adulthood
- ClinicalTrials.gov ID
- NCT01306799
- Acronym / sponsor ID
- BE-CAST / 810599
- Keywords
- Barrett's Esophagus, Erosive Esophagitis, Proton Pump Inhibitor (PPI), Bone, Bone Density, GERD, ulcer prophylaxis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH)
- Study start
- Jan 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 2 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Barrett's Esophagus, Erosive Esophagitis, GERD | – | – |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Pre-menopausal women
- men under 40 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Volumetric bone mineral density as measured by pQCT
Time frame: 3 years
2 secondary outcomes
measure PTH levels at each study visit
Time frame: 3 years
measure vitamin B12 levels at each study visit
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Xiao Yang, MD, MSCE principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett's Esophagus and Erosive Esophagitis, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumetric bone mineral density as measured by pQCT (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.