Asthma, Bone Density, Low, Oral Steroid-Dependent Asthma (Disorder)
Conditions
Keywords
Glucocorticoid, Corticosteroid
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.
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
Sponsors
University of Iowa
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DXA Bone Mineral Density | Baseline | DXA Bone Mineral Density score will be obtained using standard DXA scans and compared between oral steroid and control groups. |
| Marrow Adipose Tissue | Baseline | 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. |
| Cortical Bone Density | Baseline | 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. |
| Peripheral Bone Density | Baseline | 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. |
| Bone Geometry and Microstructure | Baseline | 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. |
| DXA Body Composition Analysis (fat mass, lean mass, percent fat) | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Marrow Adipose Tissue | Change from baseline to 6-month follow up visit | 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. |
| Cortical Bone Density | Change from baseline to 6-month follow up visit | 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. |
| Peripheral Bone Density | Change from baseline to 6-month follow up visit | 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. |
| Bone Geometry and Microstructure | Change from baseline to 6-month follow up visit | 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. |
| DXA Body Composition Analysis (fat mass, lean mass, percent fat) | Change from baseline to 6-month follow up visit | 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. |
| DXA Bone Mineral Density | Change from baseline to 6-month follow-up visit | 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. |
Countries
United States
Contacts
Primary ContactTaylor M Haynes, MS
Backup ContactPunam K Saha, PhD
Outcome results
None listed