Effects of Swallowed Steroids on Bone Density and Growth in Pediatric Eosinophilic Esophagitis

NCT ID: NCT03615950

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2020-07-31

Brief Summary

Eosinophilic esophagitis (EoE) is characterized by allergy-driven inflammation of the esophagus leading to a variety of gastrointestinal symptoms and increased healthcare utilization. While considered a rare disease, EoE is rapidly increasing in prevalence in the United States. Treatment options are limited and include dietary modifications with the elimination of suspected food triggers or pharmacological options including proton pump inhibitors (PPIs) and swallowed corticosteroids. Compliance to strict elimination diets is difficult thus many patients elect to use swallowed corticosteroids. Because nearly half of all EoE patients are treated with swallowed corticosteroids there is a growing concern regarding the long-term effects of this class of medication.4

It is known that oral corticosteroids can compromise bone mineral density and growth velocity5-7. Furthermore, there have been multiple studies exploring the relationship between inhaled corticosteroids (ICS) and endocrine effects in asthmatics. While the risk of ICS use is less compared to systemic corticosteroids, higher ICS doses do cause deleterious effects on growth and bone health8-11. Currently, there are no published studies examining the effect of swallowed corticosteroids on bone mineral density or growth velocity in patients with EoE. Given the route of administration, there may be more systemic absorption leading to a higher risk of long-term complications.

The proposed work will address the following specific aims:

Specific Aim 1: Assess effects of swallowed corticosteroids on bone mineral density (primary outcome) in children 5-12 years of age with EoE compared to age matched controls.

Specific Aim 2: Evaluation of the effect of swallowed corticosteroids on growth velocity.

Conditions

Eosinophilic Esophagitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Intervention Group

30 Children with eosinophilic esophagitis who are started on swallowed corticosteroids by their clinical provider.

Bone Mineral Density (DEXA) scan

Intervention Type: DIAGNOSTIC_TEST

Radiologic assessment of bone mineral density in the lumbar spine. This will be performed at screening. If abnormal at screening, subjects will not be enrolled. For enrolled subjects, DEXA will be repeated at 12 months.

Vitamin D Measurement

Intervention Type: DIAGNOSTIC_TEST

Measurement of 25-hydroxy vitamin D levels through the blood at baseline and 12 months. If low for age, subjects will receive dietary counseling to increase intake to recommended levels. Primary care providers of enrolled subjects will be notified of abnormal results.

Height measurement

Intervention Type: DIAGNOSTIC_TEST

Height will be measured at baseline and 12 months.

Assessment of medication compliance

Intervention Type: OTHER

Subjects enrolled in the intervention group will undergo assessment of compliance with swallowed corticosteroids prescribed by their clinical provider. This will be performed at 6 and 12 months.

Control Group

30 children, 5-12 years of age, not taking swallowed corticosteroids. Age and sex matched 1:1 with intervention group.

Bone Mineral Density (DEXA) scan

Intervention Type: DIAGNOSTIC_TEST

Radiologic assessment of bone mineral density in the lumbar spine. This will be performed at screening. If abnormal at screening, subjects will not be enrolled. For enrolled subjects, DEXA will be repeated at 12 months.

Vitamin D Measurement

Intervention Type: DIAGNOSTIC_TEST

Measurement of 25-hydroxy vitamin D levels through the blood at baseline and 12 months. If low for age, subjects will receive dietary counseling to increase intake to recommended levels. Primary care providers of enrolled subjects will be notified of abnormal results.

Height measurement

Intervention Type: DIAGNOSTIC_TEST

Height will be measured at baseline and 12 months.

Interventions

Bone Mineral Density (DEXA) scan

Radiologic assessment of bone mineral density in the lumbar spine. This will be performed at screening. If abnormal at screening, subjects will not be enrolled. For enrolled subjects, DEXA will be repeated at 12 months.

Intervention Type: DIAGNOSTIC_TEST

Vitamin D Measurement

Measurement of 25-hydroxy vitamin D levels through the blood at baseline and 12 months. If low for age, subjects will receive dietary counseling to increase intake to recommended levels. Primary care providers of enrolled subjects will be notified of abnormal results.

Intervention Type: DIAGNOSTIC_TEST

Height measurement

Height will be measured at baseline and 12 months.

Intervention Type: DIAGNOSTIC_TEST

Assessment of medication compliance

Subjects enrolled in the intervention group will undergo assessment of compliance with swallowed corticosteroids prescribed by their clinical provider. This will be performed at 6 and 12 months.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Intervention:

1. Age 5-12 years

2. Diagnosis of EoE based upon a peak eosinophil count of ≥ 15 eosinophils/high powered field (hpf) on at least one esophageal biopsy while on a minimum of 8 weeks of PPI therapy

3. Patient/Family has elected to start swallowed corticosteroids for the treatment of EoE with a minimum daily dose of at least 0.5 mg budesonide or 440 mcg fluticasone. The decision to start swallowed corticosteroids will be made based upon the judgement of the provider, potential subject, and family during a clinic visit and will not be part of the research procedures.

• Controls:

1. Age 5-12 years

2. Followed in the ACH allergy clinic, but not required to have a diagnosis of EoE

3. Not treated with swallowed corticosteroids

Exclusion Criteria

• Intervention and controls:

1. Non-English speaking

2. Patients actively taking systemic corticosteroids or previous use of systemic corticosteroids within the past 6 months

3. Patients actively taking inhaled corticosteroids or prior use of inhaled corticosteroids in the 6 months prior to screening

4. Current or previous treatment with swallowed corticosteroids for EoE at the time of screening

5. Osteopenia or osteoporosis on baseline dual energy X-ray absorptiometry (DEXA).

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: collaborator

Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

ACHEOEBMD

Identifier Type: -

Identifier Source: org_study_id