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

Arkansas Children's Hospital Research Institute

Status

Unknown

Conditions

Eosinophilic Esophagitis

Treatments

Diagnostic Test: Vitamin D Measurement

Other: Assessment of medication compliance

Diagnostic Test: Height measurement

Diagnostic Test: Bone Mineral Density (DEXA) scan

Study type

Observational

Funder types

Other

Identifiers

NCT03615950

ACHEOEBMD

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

5 to 12 years old

Volunteers

No Healthy Volunteers

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).