Pulmonary Disease, Chronic ObstructiveNCT03534934
CT-Based Modeling of Bone Micro-Architecture and Fracture-Risk in COPD
A study testing Vital signs, Urine Pregnancy Test and Questionnaires in people with Pulmonary Disease, Chronic Obstructive and Osteoporosis, run by Punam K Saha at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Osteoporosis
- What is being tested?
- Vital signs, Urine Pregnancy Test and Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Feb 2019to 19 Mar 2025
- Phase
- Interventional
- 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 45 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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%).
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Columbia University Medical Center
New York, New York, 10032
About this study
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.
Read the detailed description
This translational study seeks to establish a Chronic Obstructive Pulmonary Disease (COPD)-specific fracture prediction model using the investigators unique computed tomography (CT)-based assessment of peripheral bone micro-architecture. Osteoporosis, a common comorbidity among patients with COPD, accelerates morbidity and mortality. The basis for this comorbidity is poorly understood, thus the need for characterizing the link between COPD-related factors and bone micro-architecture and their association to fracture-risk. Multiple COPD-related factors are associated with osteoporosis. Different COPD-related causes of bone loss may non-uniformly impact cortical and trabecular bone structures with varying mechanical consequences, reflective of divergent COPD-associated fracture-risk in individuals with similar bone mineral density (BMD). Little is known about this linkage, and the study goal is to fill this knowledge gap using a clinically suitable emerging CT-based tool for characterization of bone micro-architecture at peripheral sites. Specifically, this study will-(1) establish the generalizability of the investigators bone micro-architecture assessment applied to emerging low dose / high resolution CT scanners from different vendors; (2) assess its potential as compared to dual energy x-ray absorptiometry (DXA) to explain prevalent fractures and predict incident fractures among patients with COPD; (3) quantify the impact of different COPD-related factors on bone structures and their implications for fracture-risk; (4) identify COPD subtypes with rapid bone structural degeneration; and (5) develop a COPD-specific model for assessment of fracture-risk using patient-specific data.
The study will take advantage of-(1) existing COPD patient cohorts with lung characterization at the University of Iowa (UI) and Columbia University (CU) representing a wide demographic range; (2) access to emerging CT scanners at both sites; and (3) unique image processing methodologies for quantifying three-dimensional bone structural metrics. The study will recruit 550 smokers with and without COPD from the UI and CU cohorts of the COPDGene and SPIROMICS studies. Smokers without COPD will comprise the control group for the study. At baseline and 3-year follow-up visits, the study team will collect-(1) data related to risk factors; (2) a lateral spine CT scout scan to assess vertebral fractures; (3) high resolution CT scans of the hip and ankle for computation of bone structural metrics; (4) whole-body, spine and hip DXA scans for evaluation of bone mineral density and body composition; and (5) DXA vertebral fracture assessment.
This study will establish an emerging CT-based scanner-independent generalizable tool to assess bone response to different therapeutic interventions aimed at slowing or reversing bone loss, and possibly restoring bone structure, potentially leading to more patient-specific interventions. Also, this study seeks to explain the relationships among various COPD-related factors, bone structural changes and their implications for fracture-risk.
Finally, a COPD-specific model for assessment of fracture-risk will be developed 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.
- Being tested
- Vital signs, Urine Pregnancy Test, Questionnaires, Blood Test, Duel-energy X-ray absorptiometry scan
- Keywords
- COPD, Osteoporosis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vital signsDiagnostic test
Heart rate, respirations, blood pressure, temperature, oxygen saturation
arterial oxygen saturation (SaO2), height and weight
Urine Pregnancy TestDiagnostic test
Urine pregnancy test done on woman of childbearing potential.
QuestionnairesOther
Subject Questionnaire Calcium Intake Questionnaire Home and Work Activities Survey
Blood TestDiagnostic test
Blood test for vitamin D level, Hemoglobin A1c, and creatinine level
Duel-energy X-ray absorptiometry scanDiagnostic test
Also called DXA scan
Bone density measurement
Multi-detector computed tomographyDiagnostic test
Also called MDCT, CT scan
Hip and ankle CT scan
Dual-energy X-ray absorptiometry scanDiagnostic test
Also called DXA scan
Vertebral fracture assessment
| Study group | Role | What they receive |
|---|---|---|
| Baseline | Experimental | Smokers, 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 Receives: Diagnostic Test: Vital signs; Diagnostic Test: Urine Pregnancy Test; Other: Questionnaires; Diagnostic Test: Blood Test; Diagnostic Test: Duel-energy X-ray absorptiometry scan; Diagnostic Test: Multi-detector computed tomography; Diagnostic Test: Dual-energy X-ray absorptiometry scan |
| 3 year follow-up | Experimental | All 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 Receives: Diagnostic Test: Vital signs; Diagnostic Test: Urine Pregnancy Test; Other: Questionnaires; Diagnostic Test: Blood Test; Diagnostic Test: Duel-energy X-ray absorptiometry scan; Diagnostic Test: Multi-detector computed tomography; Diagnostic Test: Dual-energy X-ray absorptiometry scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline Visit
Secondary outcomes (2)
CT bone mineral density at the spine
Method: CT measures of thoracic spine bone mineral density will be computed using a chest CT scan and computerized algorithms.
Measured: Change from baseline and three year follow up visit
DXA Bone Mineral Density
DXA Bone Mineral Density score will be obtained using standard DXA scans.
Measured: Change from baseline and three year 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 posted23 May 2018
- Study start26 Feb 2019
- Primary completion19 Mar 2025
- Study completion19 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- All subjects will participate in both baseline and three year follow-up visits and undergo identical interventions.
- Masking
- None (open label)
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Punam K Saha
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Punam K Saha, University of Iowa
- Investigators
- Punam Saha, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534934
- Sponsor's protocol ID
- 201802724
- Other IDs
- R01HL142042
- Status last verified
- Jan 2026
- First submitted
- 16 Apr 2018
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT-Based Modeling of Bone Micro-Architecture and Fracture-Risk in COPD
- ClinicalTrials.gov ID
- NCT03534934
- Acronym / sponsor ID
- 201802724
- Keywords
- COPD, Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Punam K SahaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 19 Mar 2025 (actual)
- First posted
- 23 May 2018 (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 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.
Detailed description
This translational study seeks to establish a Chronic Obstructive Pulmonary Disease (COPD)-specific fracture prediction model using the investigators unique computed tomography (CT)-based assessment of peripheral bone micro-architecture. Osteoporosis, a common comorbidity among patients with COPD, accelerates morbidity and mortality. The basis for this comorbidity is poorly understood, thus the need for characterizing the link between COPD-related factors and bone micro-architecture and their association to fracture-risk. Multiple COPD-related factors are associated with osteoporosis. Different COPD-related causes of bone loss may non-uniformly impact cortical and trabecular bone structures with varying mechanical consequences, reflective of divergent COPD-associated fracture-risk in individuals with similar bone mineral density (BMD). Little is known about this linkage, and the study goal is to fill this knowledge gap using a clinically suitable emerging CT-based tool for characterization of bone micro-architecture at peripheral sites. Specifically, this study will-(1) establish the generalizability of the investigators bone micro-architecture assessment applied to emerging low dose / high resolution CT scanners from different vendors; (2) assess its potential as compared to dual energy x-ray absorptiometry (DXA) to explain prevalent fractures and predict incident fractures among patients with COPD; (3) quantify the impact of different COPD-related factors on bone structures and their implications for fracture-risk; (4) identify COPD subtypes with rapid bone structural degeneration; and (5) develop a COPD-specific model for assessment of fracture-risk using patient-specific data.
The study will take advantage of-(1) existing COPD patient cohorts with lung characterization at the University of Iowa (UI) and Columbia University (CU) representing a wide demographic range; (2) access to emerging CT scanners at both sites; and (3) unique image processing methodologies for quantifying three-dimensional bone structural metrics. The study will recruit 550 smokers with and without COPD from the UI and CU cohorts of the COPDGene and SPIROMICS studies. Smokers without COPD will comprise the control group for the study. At baseline and 3-year follow-up visits, the study team will collect-(1) data related to risk factors; (2) a lateral spine CT scout scan to assess vertebral fractures; (3) high resolution CT scans of the hip and ankle for computation of bone structural metrics; (4) whole-body, spine and hip DXA scans for evaluation of bone mineral density and body composition; and (5) DXA vertebral fracture assessment.
This study will establish an emerging CT-based scanner-independent generalizable tool to assess bone response to different therapeutic interventions aimed at slowing or reversing bone loss, and possibly restoring bone structure, potentially leading to more patient-specific interventions. Also, this study seeks to explain the relationships among various COPD-related factors, bone structural changes and their implications for fracture-risk.
Finally, a COPD-specific model for assessment of fracture-risk will be developed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All subjects will participate in both baseline and three year follow-up visits and undergo identical interventions.
| Arm | Type | Receives |
|---|---|---|
| Baseline | Experimental | Diagnostic Test: Vital signs, Diagnostic Test: Urine Pregnancy Test, Other: Questionnaires, Diagnostic Test: Blood Test, Diagnostic Test: Duel-energy X-ray absorptiometry scan, Diagnostic Test: Multi-detector computed tomography, Diagnostic Test: Dual-energy X-ray absorptiometry scanSmokers, 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 | Experimental | Diagnostic Test: Vital signs, Diagnostic Test: Urine Pregnancy Test, Other: Questionnaires, Diagnostic Test: Blood Test, Diagnostic Test: Duel-energy X-ray absorptiometry scan, Diagnostic Test: Multi-detector computed tomography, Diagnostic Test: Dual-energy X-ray absorptiometry scanAll 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 |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%).
Key exclusion criteria (6 listed)
- 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)
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 |
|---|---|---|
| Vital signsHeart rate, respirations, blood pressure, temperature, oxygen saturation arterial oxygen saturation (SaO2), height and weight | Diagnostic test | 3 year follow-up, Baseline |
| Urine Pregnancy TestUrine pregnancy test done on woman of childbearing potential. | Diagnostic test | 3 year follow-up, Baseline |
| QuestionnairesSubject Questionnaire Calcium Intake Questionnaire Home and Work Activities Survey | Other | 3 year follow-up, Baseline |
| Blood TestBlood test for vitamin D level, Hemoglobin A1c, and creatinine level | Diagnostic test | 3 year follow-up, Baseline |
| Duel-energy X-ray absorptiometry scanAlso: DXA scanBone density measurement | Diagnostic test | 3 year follow-up, Baseline |
| Multi-detector computed tomographyAlso: MDCT, CT scanHip and ankle CT scan | Diagnostic test | 3 year follow-up, Baseline |
| Dual-energy X-ray absorptiometry scanAlso: DXA scanVertebral fracture assessment | Diagnostic test | 3 year follow-up, Baseline |
Primary outcome
Prevalent vertebral fractures at baseline
Time frame: Baseline Visit
Method: Prevalent fracture cases at the baseline visit will be determined using expert visual reading of the baseline lateral spine CT scout scan.
CT-based fracture-risk
Time frame: Baseline Visit
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.
DXA-based fracture risk
Time frame: Baseline Visit
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.
2 secondary outcomes
CT bone mineral density at the spine
Time frame: Change from baseline and three year follow up visit
DXA Bone Mineral Density
Time frame: Change from baseline and three year follow up visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
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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 Saha, PhD principal investigator
University of Iowa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vital signs, Urine Pregnancy Test and Questionnaires in people with Pulmonary Disease, Chronic Obstructive and Osteoporosis, run by Punam K Saha at 2 sites 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalent vertebral fractures at baseline (time frame: Baseline Visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2026.