NCT04518722

CT-Based Changes in Bone and Marrow Among Patients on Oral Steroids

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 25 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to assess the feasibility of emerging CT-based tools to measure changes in central and peripheral bone density, micro-structure, and marrow adipose tissue (MAT) among patients treated with oral steroids.

Detailed description

This study aims to prove that emerging CT-based tools are suitable to measure changes in central and peripheral bone density, geometry, micro-structure, and marrow adipose tissue (MAT) among patients treated with oral steroids. To do this, investigators will recruit 10 non-smokers (defined as \< 10 pack-year smoking history) age 25-45 years with a diagnosis of severe, persistent asthma who either chronically use oral steroids or do not use any oral steroids. Participants will undergo dual-energy X-ray absorptiometry (DXA), dual-energy mid-tibia CT, high-resolution single-energy ankle CT, and low-radiation hip CT scans at baseline and 6-month follow-up visits. The images obtained will be used to analyze cross-sectional differences in central and peripheral bone density, geometry, micro-structure, and MAT between patients using oral steroids versus those who do not use any oral steroids. Differences in imaging at baseline and six-month follow visits will be used to analyze longitudinal bone changes among patients with oral steroid treatment.

Conditions

• Asthma
• Bone Density, Low
• Oral Steroid-Dependent Asthma (Disorder)

Interventions

Type	Name	Description
RADIATION	CT Scan	Dual-energy mid-tibia CT, high-resolution single energy MDCT imaging of the distal tibia (ankle), and low radiation hip CT scans
RADIATION	DXA Scan	Basic DXA scans will be performed to measure areal BMD and body composition measures at the whole body, spine, and hip
OTHER	Steroid Intake Questionnaire	Questionnaire designed to quantify lifetime oral glucocorticoid intake

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-09-28
• Completion: 2021-09-28
• First posted: 2020-08-19
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States