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

• Conditions: Eosinophilic Esophagitis
• Interventions: Diagnostic Test: Bone Mineral Density (DEXA) scan; Diagnostic Test: Vitamin D Measurement; Diagnostic Test: Height measurement; Other: Assessment of medication compliance

• Registration Number: NCT03615950
• Lead Sponsor: Arkansas Children's Hospital Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-24
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-06
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-11
• Last Update Posted: 2019-07-12
• Study Start: 2019-10-01
• Primary Completion: 2020-08-01
• Study Completion: 2020-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention Group	Height measurement	30 Children with eosinophilic esophagitis who are started on swallowed corticosteroids by their clinical provider.
Control Group	Vitamin D Measurement	30 children, 5-12 years of age, not taking swallowed corticosteroids. Age and sex matched 1:1 with intervention group.
Intervention Group	Bone Mineral Density (DEXA) scan	30 Children with eosinophilic esophagitis who are started on swallowed corticosteroids by their clinical provider.
Intervention Group	Vitamin D Measurement	30 Children with eosinophilic esophagitis who are started on swallowed corticosteroids by their clinical provider.
Intervention Group	Assessment of medication compliance	30 Children with eosinophilic esophagitis who are started on swallowed corticosteroids by their clinical provider.
Control Group	Bone Mineral Density (DEXA) scan	30 children, 5-12 years of age, not taking swallowed corticosteroids. Age and sex matched 1:1 with intervention group.
Control Group	Height measurement	30 children, 5-12 years of age, not taking swallowed corticosteroids. Age and sex matched 1:1 with intervention group.

Primary Outcome Measures

Name	Time	Method
Effects of swallowed corticosteroids on bone mineral density	12 months	Change in bone mineral density over 1 year while being treated with swallowed corticosteroids compared to age-matched controls

Secondary Outcome Measures

Name	Time	Method
Effects of swallowed corticosteroids on linear growth	12 months	Changes in linear growth over 1 year while being treated with swallowed corticosteroids compared to controls

Trial Locations

Locations (1)

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States