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

Completed · Not applicable

Conditions studied: Pulmonary Disease, Chronic Obstructive, Osteoporosis

In brief

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.

Key facts

Study ID

NCT03534934

Run by

Punam K Saha

People needed

560

Starts

2019-02-26

Expected to finish

2025-03-19

Last updated by the study team

2026-01-28

Who can join

Age: 45 and older, up to 90. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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