AsthmaNCT04518722
CT-Based Changes in Bone and Marrow Among Patients on Oral Steroids
An observational study of Asthma and Bone Density, Low, run by University of Iowa at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Asthma, Bone Density, Low, Oral Steroid-Dependent Asthma (Disorder)
- What is being tested?
- CT Scan, DXA Scan and Steroid Intake Questionnaire
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 28 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- Diagnosis of severe, persistent asthma (defined as using both a long-acting beta-agonist AND a high-dose inhaled steroid)
- Age 25-45
- Chronic treatment with oral steroids for at least 45 days but less than 1 year
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- CT Scan, DXA Scan, Steroid Intake Questionnaire
- Keywords
- Glucocorticoid, Corticosteroid
- Medical subject headings
- Asthma, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT ScanRadiation
Also called CAT Scan
Dual-energy mid-tibia CT, high-resolution single energy MDCT imaging of the distal tibia (ankle), and low radiation hip CT scans
DXA ScanRadiation
Also called Bone Density Scan
Basic DXA scans will be performed to measure areal BMD and body composition measures at the whole body, spine, and hip
Steroid Intake QuestionnaireOther
Questionnaire designed to quantify lifetime oral glucocorticoid intake
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
DXA Bone Mineral Density
DXA Bone Mineral Density score will be obtained using standard DXA scans and compared between oral steroid and control groups.
Measured: Baseline
Secondary outcomes (6)
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.
Measured: Change from baseline to 6-month follow up visit
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.
Measured: Change from baseline to 6-month follow up visit
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.
Measured: Change from baseline to 6-month follow up visit
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.
Measured: Change from baseline to 6-month follow up visit
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.
Measured: Change from baseline to 6-month follow up visit
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.
Measured: Change from baseline to 6-month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Dec 2020
- Primary completion28 Sep 2021
- Study completion28 Sep 2021
Why it stopped: The PI was not awarded the funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Punam K Saha, University of Iowa
- Investigators
- Punam K Saha, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518722
- Sponsor's protocol ID
- 202009045
- Status last verified
- Jan 2026
- First submitted
- 14 Aug 2020
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10841167Canalis E, Mazziotti G, Giustina A, Bilezikian JP. Glucocorticoid-induced osteoporosis: pathophysiology and therapy. Osteoporos Int. 2007 Oct;18(10):1319-28. doi: 10.1007/s00198-007-0394-0. Epub 2007 Jun 14.
PubMed 17566815Clowes JA, Peel N, Eastell R. Glucocorticoid-induced osteoporosis. Curr Opin Rheumatol. 2001 Jul;13(4):326-32. doi: 10.1097/00002281-200107000-00015.
PubMed 11555737Wehrli FW, Saha PK, Gomberg BR, Song HK, Snyder PJ, Benito M, Wright A, Weening R. Role of magnetic resonance for assessing structure and function of trabecular bone. Top Magn Reson Imaging. 2002 Oct;13(5):335-55. doi: 10.1097/00002142-200210000-00005.
PubMed 12464746Barger-Lux MJ, Recker RR. Bone microstructure in osteoporosis: transilial biopsy and histomorphometry. Top Magn Reson Imaging. 2002 Oct;13(5):297-305. doi: 10.1097/00002142-200210000-00002.
PubMed 12464743Bell KL, Loveridge N, Power J, Garrahan N, Meggitt BF, Reeve J. Regional differences in cortical porosity in the fractured femoral neck. Bone. 1999 Jan;24(1):57-64. doi: 10.1016/s8756-3282(98)00143-4.
PubMed 9916785Kleerekoper M, Villanueva AR, Stanciu J, Rao DS, Parfitt AM. The role of three-dimensional trabecular microstructure in the pathogenesis of vertebral compression fractures. Calcif Tissue Int. 1985 Dec;37(6):594-7. doi: 10.1007/BF02554913.
PubMed 3937580Legrand E, Chappard D, Pascaretti C, Duquenne M, Krebs S, Rohmer V, Basle MF, Audran M. Trabecular bone microarchitecture, bone mineral density, and vertebral fractures in male osteoporosis. J Bone Miner Res. 2000 Jan;15(1):13-9. doi: 10.1359/jbmr.2000.15.1.13.
PubMed 10646109Legrand E, Audran M, Guggenbuhl P, Levasseur R, Chales G, Basle MF, Chappard D. Trabecular bone microarchitecture is related to the number of risk factors and etiology in osteoporotic men. Microsc Res Tech. 2007 Nov;70(11):952-9. doi: 10.1002/jemt.20501.
PubMed 17661392Moore RJ, Durbridge TC, McNeil PJ, Parkinson IH, Need AG, Vernon-Roberts B. Trabecular spacing in post-menopausal Australian women with and without vertebral fractures. Aust N Z J Med. 1992 Jun;22(3):269-73. doi: 10.1111/j.1445-5994.1992.tb02124.x.
PubMed 1386728Mosekilde L. Consequences of the remodelling process for vertebral trabecular bone structure: a scanning electron microscopy study (uncoupling of unloaded structures). Bone Miner. 1990 Jul;10(1):13-35. doi: 10.1016/0169-6009(90)90046-i.
PubMed 2397325Parfitt AM, Mathews CH, Villanueva AR, Kleerekoper M, Frame B, Rao DS. Relationships between surface, volume, and thickness of iliac trabecular bone in aging and in osteoporosis. Implications for the microanatomic and cellular mechanisms of bone loss. J Clin Invest. 1983 Oct;72(4):1396-409. doi: 10.1172/JCI111096.
PubMed 6630513Parfitt AM. Implications of architecture for the pathogenesis and prevention of vertebral fracture. Bone. 1992;13 Suppl 2:S41-7. doi: 10.1016/8756-3282(92)90196-4.
PubMed 1627414Recker RR. Architecture and vertebral fracture. Calcif Tissue Int. 1993;53 Suppl 1:S139-42. doi: 10.1007/BF01673423.
PubMed 8275368Vesterby A, Gundersen HJ, Melsen F, Mosekilde L. Marrow space star volume in the iliac crest decreases in osteoporotic patients after continuous treatment with fluoride, calcium, and vitamin D2 for five years. Bone. 1991;12(1):33-7. doi: 10.1016/8756-3282(91)90052-k.
PubMed 2054234
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT-Based Changes in Bone and Marrow Among Patients on Oral Steroids
- ClinicalTrials.gov ID
- NCT04518722
- Acronym / sponsor ID
- 202009045
- Keywords
- Glucocorticoid, Corticosteroid
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The PI was not awarded the funding.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 28 Sep 2021 (actual)
- Study completion
- 28 Sep 2021 (actual)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT ScanAlso: CAT ScanDual-energy mid-tibia CT, high-resolution single energy MDCT imaging of the distal tibia (ankle), and low radiation hip CT scans | Radiation | – |
| DXA ScanAlso: Bone Density ScanBasic DXA scans will be performed to measure areal BMD and body composition measures at the whole body, spine, and hip | Radiation | – |
| Steroid Intake QuestionnaireQuestionnaire designed to quantify lifetime oral glucocorticoid intake | Other | – |
Primary outcome
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.
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.
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.
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.
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.
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.
6 secondary outcomes
Marrow Adipose Tissue
Time frame: Change from baseline to 6-month follow up visit
Cortical Bone Density
Time frame: Change from baseline to 6-month follow up visit
Peripheral Bone Density
Time frame: Change from baseline to 6-month follow up visit
Bone Geometry and Microstructure
Time frame: Change from baseline to 6-month follow up visit
DXA Body Composition Analysis (fat mass, lean mass, percent fat)
Time frame: Change from baseline to 6-month follow up visit
DXA Bone Mineral Density
Time frame: Change from baseline to 6-month follow-up visit
Results and safety
The study was stopped early (reason given: The PI was not awarded the funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 10841167Van 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.
- Background: PubMed 17566815Canalis E, Mazziotti G, Giustina A, Bilezikian JP. Glucocorticoid-induced osteoporosis: pathophysiology and therapy. Osteoporos Int. 2007 Oct;18(10):1319-28. doi: 10.1007/s00198-007-0394-0. Epub 2007 Jun 14.
- Background: PubMed 11555737Clowes JA, Peel N, Eastell R. Glucocorticoid-induced osteoporosis. Curr Opin Rheumatol. 2001 Jul;13(4):326-32. doi: 10.1097/00002281-200107000-00015.
- Background: PubMed 12464746Wehrli FW, Saha PK, Gomberg BR, Song HK, Snyder PJ, Benito M, Wright A, Weening R. Role of magnetic resonance for assessing structure and function of trabecular bone. Top Magn Reson Imaging. 2002 Oct;13(5):335-55. doi: 10.1097/00002142-200210000-00005.
- Background: PubMed 12464743Barger-Lux MJ, Recker RR. Bone microstructure in osteoporosis: transilial biopsy and histomorphometry. Top Magn Reson Imaging. 2002 Oct;13(5):297-305. doi: 10.1097/00002142-200210000-00002.
- Background: PubMed 9916785Bell KL, Loveridge N, Power J, Garrahan N, Meggitt BF, Reeve J. Regional differences in cortical porosity in the fractured femoral neck. Bone. 1999 Jan;24(1):57-64. doi: 10.1016/s8756-3282(98)00143-4.
- Background: PubMed 3937580Kleerekoper M, Villanueva AR, Stanciu J, Rao DS, Parfitt AM. The role of three-dimensional trabecular microstructure in the pathogenesis of vertebral compression fractures. Calcif Tissue Int. 1985 Dec;37(6):594-7. doi: 10.1007/BF02554913.
- Background: PubMed 10646109Legrand E, Chappard D, Pascaretti C, Duquenne M, Krebs S, Rohmer V, Basle MF, Audran M. Trabecular bone microarchitecture, bone mineral density, and vertebral fractures in male osteoporosis. J Bone Miner Res. 2000 Jan;15(1):13-9. doi: 10.1359/jbmr.2000.15.1.13.
- Background: PubMed 17661392Legrand E, Audran M, Guggenbuhl P, Levasseur R, Chales G, Basle MF, Chappard D. Trabecular bone microarchitecture is related to the number of risk factors and etiology in osteoporotic men. Microsc Res Tech. 2007 Nov;70(11):952-9. doi: 10.1002/jemt.20501.
- Background: PubMed 1386728Moore RJ, Durbridge TC, McNeil PJ, Parkinson IH, Need AG, Vernon-Roberts B. Trabecular spacing in post-menopausal Australian women with and without vertebral fractures. Aust N Z J Med. 1992 Jun;22(3):269-73. doi: 10.1111/j.1445-5994.1992.tb02124.x.
- Background: PubMed 2397325Mosekilde L. Consequences of the remodelling process for vertebral trabecular bone structure: a scanning electron microscopy study (uncoupling of unloaded structures). Bone Miner. 1990 Jul;10(1):13-35. doi: 10.1016/0169-6009(90)90046-i.
- Background: PubMed 6630513Parfitt AM, Mathews CH, Villanueva AR, Kleerekoper M, Frame B, Rao DS. Relationships between surface, volume, and thickness of iliac trabecular bone in aging and in osteoporosis. Implications for the microanatomic and cellular mechanisms of bone loss. J Clin Invest. 1983 Oct;72(4):1396-409. doi: 10.1172/JCI111096.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Punam K Saha, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Bone Density, Low, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The PI was not awarded the funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marrow Adipose Tissue (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04518722, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.