Clinical trial NCT04518722: CT-Based Changes in Bone and Marrow Among Patients on Oral Steroids
Official title: CT-Based Changes in Bone and Marrow Among Patients on Oral Steroids
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Bone Density, Low
Oral Steroid-Dependent Asthma (Disorder)
Keywords: Glucocorticoid
Corticosteroid
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 12
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We plan to enroll 12 subjects, divided into two groups of 6. We will recruit 6 subjects with a diagnosis of severe, persistent asthma who have been taking oral GCs for 1.5-11 months. We will also recruit 6 subjects with a diagnosis of severe, persistent asthma who have not used any oral GCs in the last 12 months.

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Marrow Adipose Tissue
timeFrame: Baseline
measure: Cortical Bone Density
timeFrame: Baseline
measure: Peripheral Bone Density
timeFrame: Baseline
measure: Bone Geometry and Microstructure
timeFrame: Baseline
measure: DXA Body Composition Analysis (fat mass, lean mass, percent fat)
timeFrame: Baseline
measure: DXA Bone Mineral Density
timeFrame: Baseline
Secondary outcomes:
measure: Marrow Adipose Tissue
timeFrame: Change from baseline to 6-month follow up visit
measure: Cortical Bone Density
timeFrame: Change from baseline to 6-month follow up visit
measure: Peripheral Bone Density
timeFrame: Change from baseline to 6-month follow up visit
measure: Bone Geometry and Microstructure
timeFrame: Change from baseline to 6-month follow up visit
measure: DXA Body Composition Analysis (fat mass, lean mass, percent fat)
timeFrame: Change from baseline to 6-month follow up visit
measure: DXA Bone Mineral Density
timeFrame: Change from baseline to 6-month follow-up visit
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Punam K Saha, PhD
role: PRINCIPAL_INVESTIGATOR
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