CT-Based Modeling of Bone Micro-Architecture and Fracture-Risk in COPD
2 other identifiers
interventional
560
1 country
2
Brief Summary
The goal of this translational study is to establish a newly emerging CT-based tool for the characterization of changes in bone micro-architecture and assessment of their implications for fracture-risk in a population of COPD patients at risk for osteoporosis. The tool will be suitable and generalizable across emerging CT scanners from different vendors, and it will provide a more structurally-based assessment of osteoporosis and bone loss than is provided by simple bone density measures. The study will characterize the impact of different COPD-related factors on bone structure, and their implications for fracture-risk, leading to the development of a COPD-specific model for assessment of fracture-risk that will utilize patient-specific demographic, clinical and radiographic data, and CT BMD at the spine, as well as bone structural measures at the hip and/or ankle.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2019
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2018
CompletedFirst Posted
Study publicly available on registry
May 23, 2018
CompletedStudy Start
First participant enrolled
February 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2025
CompletedJanuary 28, 2026
January 1, 2026
6.1 years
April 16, 2018
January 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Prevalent vertebral fractures at baseline
Method: Prevalent fracture cases at the baseline visit will be determined using expert visual reading of the baseline lateral spine CT scout scan.
Baseline Visit
CT-based fracture-risk
Method: Fragility fracture-risk will be computed using a CT-based model comprising of patient-specific demographic, clinical and radiographic data, CT bone mineral density at the spine, and CT bone micro-structural measures at the ankle.
Baseline Visit
DXA-based fracture risk
Method: Fragility fracture-risk will be computed using a DXA-based model comprising of patient-specific demographic, clinical and radiographic data, and whole-body, spine, and hip DXA bone mineral density.
Baseline Visit
Secondary Outcomes (2)
CT bone mineral density at the spine
Change from baseline and three year follow up visit
DXA Bone Mineral Density
Change from baseline and three year follow up visit.
Study Arms (2)
Baseline
EXPERIMENTALSmokers, defined has having at least a 10 pack-year lifetime history, with and without COPD will participate in the following interventions: Vital Signs Urine Pregnancy Test on woman of child bearing potential Pre- and Post-Bronchodilator Spirometry Questionnaires Blood Test for Vitamin D level, Hemoglobin A1c, and creatinine level Duel-energy X-ray absorptiometry scan (DXA) of the whole body, spine, and hip Duel-energy X-ray absorptiometry scan (DXA) for vertebral fracture assessment Multi-detector computed tomography (MDCT) of the hip and ankle
3 year follow-up
EXPERIMENTALAll subjects who completed a baseline visit will return for a follow-up visit and participate in the following interventions: Vital Signs Urine Pregnancy Test on woman of child bearing potential Pre- and Post-Bronchodilator Spirometry Questionnaires Blood Test for Vitamin D level, Hemoglobin A1c, and creatinine level Duel-energy X-ray absorptiometry scan (DXA) of the whole body, spine, and hip Duel-energy X-ray absorptiometry scan (DXA) for vertebral fracture assessment Multi-detector computed tomography (MDCT) of the hip and ankle
Interventions
Heart rate, respirations, blood pressure, temperature, oxygen saturation arterial oxygen saturation (SaO2), height and weight
Urine pregnancy test done on woman of childbearing potential.
Subject Questionnaire Calcium Intake Questionnaire Home and Work Activities Survey
Blood test for vitamin D level, Hemoglobin A1c, and creatinine level
Bone density measurement
Hip and ankle CT scan
Vertebral fracture assessment
Eligibility Criteria
You may qualify if:
- Current or former smoker, defined as having at least 10-pack year lifetime history
- Age: 45-90
- Subjects will be stratified into groups based on COPD disease status: smokers with COPD and smokers without COPD.
- Smokers with COPD will be further stratified into three groups: low emphysema (\< 3%), moderate emphysema (between 3 and 10%), and severe emphysema (\> 10%).
You may not qualify if:
- Pregnant or breast-feeding
- Metastatic Malignancy
- Currently receiving dialysis
- Any lower extremity fracture within the last year
- Any lower extremity fracture with hardware implant(s)
- History of bilateral tibia fractures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Punam K Sahalead
- National Institutes of Health (NIH)collaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (2)
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Columbia University Medical Center
New York, New York, 10032, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Punam Saha, PhD
University of Iowa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 16, 2018
First Posted
May 23, 2018
Study Start
February 26, 2019
Primary Completion
March 19, 2025
Study Completion
March 19, 2025
Last Updated
January 28, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- The data would be available about 12 months after completion of the grant, with necessary data management and statistical analyses done by then. At that time, data could be provided on the appropriate storage media through the mail, with appropriate variable labels and other necessary documentation.
- Access Criteria
- Data will only be available to researchers who formally request it and who have entered into a data-use agreement with the principal investigators.
Clinical exam, questionnaire, and image-derived data will be made available to other researchers who request it formally. The data will be de-identified and linked only by code numbers. To further minimize the risk of breaches of confidentiality, we will establish data-use sharing agreements, and consider employment of electronic firewalls, locked storage facilities, password authentication of users, audit trails, and disaster prevention/recovery plans. We will stipulate that data are used only for research purposes, that proposed research using the data will be reviewed by an Institutional Review Board, and data will not be transferred to other users. The data would be available upon completion of necessary data management and statistical analyses. At that time, data could be provided on appropriate storage media via mail. Data files would be provided in SAS format, with PDF documentation files. We also will provide copies of questionnaires and images from which our data are derived.