NCT04518722

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

5.1 years

First QC Date

August 14, 2020

Last Update Submit

January 7, 2026

Conditions

Bone Density, LowAsthmaOral Steroid-Dependent Asthma (Disorder)

Keywords

GlucocorticoidCorticosteroid

Outcome Measures

Primary 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 compared between oral steroid and control groups.

    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.

    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.

    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.

    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.

    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.

    Baseline

Secondary Outcomes (6)

  • Marrow Adipose Tissue

    Change from baseline to 6-month follow up visit

  • Cortical Bone Density

    Change from baseline to 6-month follow up visit

  • Peripheral Bone Density

    Change from baseline to 6-month follow up visit

  • Bone Geometry and Microstructure

    Change from baseline to 6-month follow up visit

  • DXA Body Composition Analysis (fat mass, lean mass, percent fat)

    Change from baseline to 6-month follow up visit

  • +1 more secondary outcomes

Interventions

CT ScanRADIATION

Dual-energy mid-tibia CT, high-resolution single energy MDCT imaging of the distal tibia (ankle), and low radiation hip CT scans

Also known as: CAT Scan
DXA ScanRADIATION

Basic DXA scans will be performed to measure areal BMD and body composition measures at the whole body, spine, and hip

Also known as: Bone Density Scan
Steroid Intake QuestionnaireOTHER

Questionnaire designed to quantify lifetime oral glucocorticoid intake

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Related Publications (22)

  • 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.

    PMID: 10841167BACKGROUND

  • Canalis 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.

    PMID: 17566815BACKGROUND

  • Clowes JA, Peel N, Eastell R. Glucocorticoid-induced osteoporosis. Curr Opin Rheumatol. 2001 Jul;13(4):326-32. doi: 10.1097/00002281-200107000-00015.

    PMID: 11555737BACKGROUND

  • Wehrli 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.

    PMID: 12464746BACKGROUND

  • Barger-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.

    PMID: 12464743BACKGROUND

  • Bell 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.

    PMID: 9916785BACKGROUND

  • Kleerekoper 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.

    PMID: 3937580BACKGROUND

  • Legrand 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.

    PMID: 10646109BACKGROUND

  • Legrand 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.

    PMID: 17661392BACKGROUND

  • Moore 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.

    PMID: 1386728BACKGROUND

  • Mosekilde 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.

    PMID: 2397325BACKGROUND

  • Parfitt 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.

    PMID: 6630513BACKGROUND

  • Parfitt 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.

    PMID: 1627414BACKGROUND

  • Recker RR. Architecture and vertebral fracture. Calcif Tissue Int. 1993;53 Suppl 1:S139-42. doi: 10.1007/BF01673423.

    PMID: 8275368BACKGROUND

  • Vesterby 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.

    PMID: 2054234BACKGROUND

  • 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.

    PMID: 14606506BACKGROUND

  • 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.

    PMID: 26233184BACKGROUND

  • 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.

    PMID: 26328990BACKGROUND

  • 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.

    PMID: 29064579BACKGROUND

  • Rosen CJ, Bouxsein ML. Mechanisms of disease: is osteoporosis the obesity of bone? Nat Clin Pract Rheumatol. 2006 Jan;2(1):35-43. doi: 10.1038/ncprheum0070.

    PMID: 16932650BACKGROUND

  • Bredella MA, Gill CM, Gerweck AV, Landa MG, Kumar V, Daley SM, Torriani M, Miller KK. Ectopic and serum lipid levels are positively associated with bone marrow fat in obesity. Radiology. 2013 Nov;269(2):534-41. doi: 10.1148/radiol.13130375. Epub 2013 Jul 16.

    PMID: 23861502BACKGROUND

  • Bredella MA, Daley SM, Kalra MK, Brown JK, Miller KK, Torriani M. Marrow Adipose Tissue Quantification of the Lumbar Spine by Using Dual-Energy CT and Single-Voxel (1)H MR Spectroscopy: A Feasibility Study. Radiology. 2015 Oct;277(1):230-5. doi: 10.1148/radiol.2015142876. Epub 2015 May 19.

    PMID: 25988401BACKGROUND

MeSH Terms

Conditions

AsthmaBone Diseases, Metabolic

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Punam K Saha, PhD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Taylor M Haynes, MS

CONTACT

319-356-1785taylor-haynes@uiowa.edu

Punam K Saha, PhD

CONTACT

319-335-5959punam-saha@uiowa.edu

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 14, 2020

First Posted

August 19, 2020

Study Start

December 1, 2020

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

January 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)