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

University of Iowa

Status: Enrolling

Conditions: Asthma; Bone Density, Low; Oral Steroid-Dependent Asthma (Disorder)

Treatments: Radiation: DXA Scan; Radiation: CT Scan; Other: Steroid Intake Questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT04518722

202009045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 25 to 45 years old

Volunteers: No Healthy Volunteers

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)