Asthma Clinical Trial
Official title:
CT-Based Changes in Bone and Marrow Among Patients on Oral Steroids
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.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | September 1, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 45 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
University of Iowa |
United States,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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