Status:

RECRUITING

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

Lead Sponsor:

University of Iowa

Conditions:

Asthma

Bone Density, Low

Eligibility:

All Genders

25-45 years

Brief 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 patient...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

December 1 2020

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 1 2026

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT04518722

Start Date

December 1 2020

End Date

January 1 2026

Last Update

January 9 2026

Active Locations (1)

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University of Iowa

Iowa City, Iowa, United States, 52242