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

Eosinophilic Esophagitis Clinical Trial

Official title:

Effects of Swallowed Corticosteroids on Bone Mineral Density and Growth Velocity in Children With Eosinophilic Esophagitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03615950
• Other study ID #: ACHEOEBMD
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: July 2019
• Source: Arkansas Children's Hospital Research Institute
• Contact: Robbie Pesek, MD
• Phone: 5013641060
• Email: rdpesek[@]uams.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 1, 2020
• Est. primary completion date: August 1, 2020
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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).

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Diagnostic Test:
• 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.
• 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.
• Height measurement
Height will be measured at baseline and 12 months.

Other:
• 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.

Locations

Country	Name	City	State
United States	Arkansas Children's Hospital	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute	University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of swallowed corticosteroids on bone mineral density	Change in bone mineral density over 1 year while being treated with swallowed corticosteroids compared to age-matched controls	12 months
Secondary	Effects of swallowed corticosteroids on linear growth	Changes in linear growth over 1 year while being treated with swallowed corticosteroids compared to controls	12 months