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

Phase

N/A

Condition

Heartburn (Pediatric)

Heartburn

Esophageal Disorders

Treatment

Height measurement

Assessment of medication compliance

Bone Mineral Density (DEXA) scan

Clinical Study ID

NCT03615950

ACHEOEBMD

Ages 5-12
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Intervention:

Age 5-12 years
Diagnosis of EoE based upon a peak eosinophil count of ≥ 15 eosinophils/highpowered field (hpf) on at least one esophageal biopsy while on a minimum of 8weeks of PPI therapy
Patient/Family has elected to start swallowed corticosteroids for the treatmentof EoE with a minimum daily dose of at least 0.5 mg budesonide or 440 mcgfluticasone. The decision to start swallowed corticosteroids will be made basedupon the judgement of the provider, potential subject, and family during aclinic visit and will not be part of the research procedures.

Controls:

Age 5-12 years
Followed in the ACH allergy clinic, but not required to have a diagnosis of EoE
Not treated with swallowed corticosteroids

Exclusion

Exclusion Criteria:

Intervention and controls:

Non-English speaking
Patients actively taking systemic corticosteroids or previous use of systemiccorticosteroids within the past 6 months
Patients actively taking inhaled corticosteroids or prior use of inhaledcorticosteroids in the 6 months prior to screening
Current or previous treatment with swallowed corticosteroids for EoE at thetime of screening
Osteopenia or osteoporosis on baseline dual energy X-ray absorptiometry (DEXA).

Study Design