Clinical trial · Observational
To Learn How Bone Structure and Bone Mass Change After Long-term PPI Use
Effect of Chronic Proton Pump Inhibitor Therapy on Bone Mineral Density and Bone Structure in Mid to Late Adulthood
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett's Esophagus | — | UNRESOLVED | — |
| Erosive Esophagitis | — | UNRESOLVED | — |
| Gastroesophageal Reflux Disease(GERD) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Barrett's Esophagus, Erosive Esophagitis, GERD
Primary outcomes (1)
- measure
- Volumetric bone mineral density as measured by pQCT
- timeFrame
- 3 years
Secondary outcomes (2)
- measure
- measure PTH levels at each study visit
- timeFrame
- 3 years
- description
- monitor change in PTH levels because long-term PPI therapy may have an affect on parathyroid glands, increasing parathyroid hormone (PTH) secretion.
- measure
- measure vitamin B12 levels at each study visit
- timeFrame
- 3 years
- description
- low B12 levels have been associated with reduced bone mineral density (BMD) as well osteoporotic fracture risk
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available