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

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.

Conditions

• Pulmonary Disease, Chronic Obstructive
• Osteoporosis

Interventions

DIAGNOSTIC_TEST

Vital signs

Heart rate, respirations, blood pressure, temperature, oxygen saturation arterial oxygen saturation (SaO2), height and weight

DIAGNOSTIC_TEST

Urine Pregnancy Test

Urine pregnancy test done on woman of childbearing potential.

OTHER

Questionnaires

Subject Questionnaire Calcium Intake Questionnaire Home and Work Activities Survey

DIAGNOSTIC_TEST

Blood Test

Blood test for vitamin D level, Hemoglobin A1c, and creatinine level

DIAGNOSTIC_TEST

Duel-energy X-ray absorptiometry scan

Bone density measurement

DIAGNOSTIC_TEST

Multi-detector computed tomography

Hip and ankle CT scan

DIAGNOSTIC_TEST

Dual-energy X-ray absorptiometry scan

Vertebral fracture assessment

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Punam K Saha

  lead OTHER

Principal Investigators

• Punam Saha, PhD · University of Iowa

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

45 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-02-26

Primary Completion

2025-03-19

Completion

2025-03-19

FDA Device

Yes

Countries

• United States

Study Locations