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

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ClinicalTrials.gov Identifier: NCT04518722
Recruitment Status : Recruiting
First Posted : August 19, 2020
Last Update Posted : February 3, 2023
Sponsor:
Information provided by (Responsible Party):
Punam K Saha, University of Iowa

Study Description
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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.

Condition or disease Intervention/treatment
Asthma Bone Density, Low Oral Steroid-Dependent Asthma (Disorder) Radiation: CT Scan Radiation: DXA Scan Other: Steroid Intake Questionnaire

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: CT-Based Changes in Bone and Marrow Among Patients on Oral Steroids
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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
    Other Name: CAT Scan
  • 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 Name: Bone Density Scan
  • Other: Steroid Intake Questionnaire
    Questionnaire designed to quantify lifetime oral glucocorticoid intake

Outcome Measures
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Primary Outcome Measures :
  1. Marrow Adipose Tissue [ Time Frame: 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.

  2. Cortical Bone Density [ Time Frame: 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.

  3. Peripheral Bone Density [ Time Frame: 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.

  4. Bone Geometry and Microstructure [ Time Frame: 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.

  5. DXA Body Composition Analysis (fat mass, lean mass, percent fat) [ Time Frame: 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.

  6. DXA Bone Mineral Density [ Time Frame: Baseline ]
    DXA Bone Mineral Density score will be obtained using standard DXA scans and compared between oral steroid and control groups.


Secondary Outcome Measures :
  1. Marrow Adipose Tissue [ Time Frame: 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.

  2. Cortical Bone Density [ Time Frame: 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.

  3. Peripheral Bone Density [ Time Frame: 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.

  4. Bone Geometry and Microstructure [ Time Frame: 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.

  5. DXA Body Composition Analysis (fat mass, lean mass, percent fat) [ Time Frame: 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.

  6. DXA Bone Mineral Density [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04518722


Contacts
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Contact: Taylor M Haynes, MS 319-356-1785 taylor-haynes@uiowa.edu
Contact: Punam K Saha, PhD 319-335-5959 punam-saha@uiowa.edu

Locations
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United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Taylor M Haynes, MS    319-356-1785    taylor-haynes@uiowa.edu   
Contact: Kimberly Sprenger, RN    319-353-8862    kimberly-sprenger@uiowa.edu   
Principal Investigator: Alejandro Comellas, MD         
Principal Investigator: Punam K Saha, PhD         
Sponsors and Collaborators
University of Iowa
Investigators
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Principal Investigator: Punam K Saha, PhD University of Iowa
More Information
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Publications:

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Responsible Party: Punam K Saha, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT04518722    
Other Study ID Numbers: 202009045
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: February 3, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Punam K Saha, University of Iowa:
Glucocorticoid
Corticosteroid
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases