RecruitingNCT04518722
CT-Based Changes in Bone and Marrow Among Patients on Oral Steroids
Sponsor
University of Iowa
Enrollment
12 participants
Start Date
Dec 1, 2020
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 25 YearsMax Age: 45 Years
Inclusion Criteria5
- 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 Criteria12
- 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)
Interventions
RADIATIONCT Scan
Dual-energy mid-tibia CT, high-resolution single energy MDCT imaging of the distal tibia (ankle), and low radiation hip CT scans
RADIATIONDXA Scan
Basic DXA scans will be performed to measure areal BMD and body composition measures at the whole body, spine, and hip
OTHERSteroid Intake Questionnaire
Questionnaire designed to quantify lifetime oral glucocorticoid intake
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04518722
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