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

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

Recruiting
25-45 years
All
Phase N/A

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Overview

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.

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.

Eligibility

Inclusion Criteria:

  • Inclusion (all subjects):
    • Diagnosis of severe, persistent asthma (defined as using both a long-acting beta-agonist AND a high-dose inhaled steroid)
    • Age 25-45
  • Inclusion (oral steroid group):
    • Chronic treatment with oral steroids for at least 45 days but less than 1 year

Exclusion Criteria:

  • Exclusion (all subjects):
    • Pregnant or breastfeeding
    • History of any cancer, excluding non-melanoma skin cancer
    • Currently receiving dialysis
    • History of any lower extremity fracture
    • Hip or knee replacement
    • Non-ambulatory
    • Greater than 10 pack-year smoking history
    • BMI > 50
    • Age < 25 or > 45
    • Current or past use of FDA-approved medication for osteoporosis:
        Bisphosphonates (Alendronate/Fosamax, Ibandronate/Boniva, Risedronate/Actonel/Atelvia,
        Zoledronic Acid/Reclast) Calcitonin (Fortical, Miacalcin) Selective Estrogen Receptor
        Modulator (Raloxifene/Evista) Parathyroid Hormone Analogue (Teriparatide/Forteo) Monoclonal
        Antibody (Denosumab/Prolia)

Study details
    Asthma
    Bone Density
    Low
    Oral Steroid-Dependent Asthma (Disorder)

NCT04518722

University of Iowa

14 April 2024

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