CT-Based Changes in Bone and Marrow Among Patients on Oral Steroids (NCT04518722) | Clinical Trial Compass
TerminatedNot Applicable
CT-Based Changes in Bone and Marrow Among Patients on Oral Steroids
Stopped: The PI was not awarded the funding.
United States2 participantsStarted 2020-12-01
Plain-language 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.
Who can participate
Age range
25 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Marrow Adipose Tissue
Timeframe: Baseline
2
Cortical Bone Density
Timeframe: Baseline
3
Peripheral Bone Density
Timeframe: Baseline
4
Bone Geometry and Microstructure
Timeframe: Baseline
5
DXA Body Composition Analysis (fat mass, lean mass, percent fat)