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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04518722
• Other study ID #: 202009045
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: September 1, 2025

Study information

• Verified date: April 2024
• Source: University of Iowa
• Contact: Taylor M Haynes, MS
• Phone: 319-356-1785
• Email: taylor-haynes[@]uiowa.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Asthma
• Bone Density, Low
• Bone Diseases, Metabolic
• Oral Steroid-Dependent Asthma (Disorder)

Intervention

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
• 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

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

References & Publications (22)

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Chen C, Zhang X, Guo J, Jin D, Letuchy EM, Burns TL, Levy SM, Hoffman EA, Saha PK. Quantitative imaging of peripheral trabecular bone microarchitecture using MDCT. Med Phys. 2018 Jan;45(1):236-249. doi: 10.1002/mp.12632. Epub 2017 Nov 23. — View Citation

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Li C, Jin D, Chen C, Letuchy EM, Janz KF, Burns TL, Torner JC, Levy SM, Saha PK. Automated cortical bone segmentation for multirow-detector CT imaging with validation and application to human studies. Med Phys. 2015 Aug;42(8):4553-65. doi: 10.1118/1.4923753. — View Citation

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Saha PK, Liu Y, Chen C, Jin D, Letuchy EM, Xu Z, Amelon RE, Burns TL, Torner JC, Levy SM, Calarge CA. Characterization of trabecular bone plate-rod microarchitecture using multirow detector CT and the tensor scale: Algorithms, validation, and applications to pilot human studies. Med Phys. 2015 Sep;42(9):5410-25. doi: 10.1118/1.4928481. — View Citation

Stone KL, Seeley DG, Lui LY, Cauley JA, Ensrud K, Browner WS, Nevitt MC, Cummings SR; Osteoporotic Fractures Research Group. BMD at multiple sites and risk of fracture of multiple types: long-term results from the Study of Osteoporotic Fractures. J Bone Miner Res. 2003 Nov;18(11):1947-54. doi: 10.1359/jbmr.2003.18.11.1947. — View Citation

Van Staa TP, Leufkens HG, Abenhaim L, Zhang B, Cooper C. Use of oral corticosteroids and risk of fractures. J Bone Miner Res. 2000 Jun;15(6):993-1000. doi: 10.1359/jbmr.2000.15.6.993. — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

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