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NCT03534934Completed

CT-Based Modeling of Bone Micro-Architecture and Fracture-Risk in COPD

Source: ClinicalTrials.gov · Last updated 28 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
560 (actual)
First submitted
16 Apr 2018
Start date
26 Feb 2019
Primary completion date
19 Mar 2025
Lead sponsor
Punam K Saha
NCT number
NCT03534934

What you commit to

  • Study type: Interventional
  • Participants enrolled: 560
  • From 26 Feb 2019 to the primary completion date, 19 Mar 2025
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently receiving dialysis
  • Any lower extremity fracture with hardware implant(s)

Other illness

  • Metastatic Malignancy
  • History of bilateral tibia fractures

Other

  • Pregnant or breast-feeding
  • Any lower extremity fracture within the last year

Who the study is looking for

  • 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%).

Age in the registry: 45 years to 90 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Iowa Hospitals and Clinics
Coordinator of this site? Confirm its status
Iowa CityUnited StatesUnknown status
Columbia University Medical Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.