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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Radiation: CT Scan
* Radiation: DXA Scan
* Other: Steroid Intake Questionnaire


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: CT Scan|Dual-energy mid-tibia CT, high-resolution single energy MDCT imaging of the distal tibia (ankle), and low radiation hip CT scans|
|Radiation: DXA Scan|Basic DXA scans will be performed to measure areal BMD and body composition measures at the whole body, spine, and hip|
|Other: Steroid Intake Questionnaire|Questionnaire designed to quantify lifetime oral glucocorticoid intake|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marrow Adipose Tissue | Marrow adipose tissue fraction at 14-16% location of the distal tibia from DECT ankle scans will be computed and compared between oral steroid and control groups. | Baseline | 
| Cortical Bone Density | Cortical bone density will be computed through CT scanning at 4-6% and 12-14% distal tibia locations and compared between oral steroid and control groups. | Baseline | 
| Peripheral Bone Density | Peripheral bone density will be computed through CT scanning at 4-6% and 12-14% distal tibia locations and compared between oral steroid and control groups. | Baseline | 
| Bone Geometry and Microstructure | Hip MDCT scans will be used compute volumetric bone mineral density (vBMD) measures over trabecular and cortical bone compartments at femoral head, femoral neck, greater trochanter, and lesser trochanter. These measurements will be compared between oral steroid and control groups. | Baseline | 
| DXA Body Composition Analysis (fat mass, lean mass, percent fat) | DXA scans will be used to acquire bone and soft tissue measures that will allow for the calculation of body composition measures, which will then be compared between oral steroid and control groups. | Baseline | 
| DXA Bone Mineral Density | DXA Bone Mineral Density score will be obtained using standard DXA scans and compared between oral steroid and control groups. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marrow Adipose Tissue | Marrow adipose tissue fraction at 14-16% location of the distal tibia from DECT ankle scans will be computed and evaluated over time in the oral steroid group. | Change from baseline to 6-month follow up visit | 
| Cortical Bone Density | Cortical bone density will be computed through CT scanning at 4-6% and 12-14% distal tibia locations and evaluated over time in the oral steroid group. | Change from baseline to 6-month follow up visit | 
| Peripheral Bone Density | Peripheral bone density will be computed through CT scanning at 4-6% and 12-14% distal tibia locations and evaluated over time in the oral steroid group. | Change from baseline to 6-month follow up visit | 
| Bone Geometry and Microstructure | Hip MDCT scans will be used compute volumetric bone mineral density (vBMD) measures over trabecular and cortical bone compartments at femoral head, femoral neck, greater trochanter, and lesser trochanter. Changes in these measurements from baseline to 6-month follow up visits will be computed for the oral steroid group. | Change from baseline to 6-month follow up visit | 
| DXA Body Composition Analysis (fat mass, lean mass, percent fat) | DXA scans will be used to acquire bone and soft tissue measures that will allow for the calculation of body composition measures. Change over time from baseline to 6-month follow up visit will be computed for the oral steroid group. | Change from baseline to 6-month follow up visit | 
| DXA Bone Mineral Density | DXA Bone Mineral Density score will be obtained using standard DXA scans. These scores will be compared at baseline and 6-month follow up visits for the oral steroid group. | Change from baseline to 6-month follow-up visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucocorticoid, Corticosteroid