CT-Based Bone Assessment for Fracture Risk in COPD

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byPunam Saha, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Punam Saha

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for current or former smokers aged 45-90 with COPD, categorized by their level of emphysema. It's not open to pregnant or breastfeeding individuals, those with recent lower extremity fractures or hardware implants in the area, people on dialysis, or those with metastatic cancer.

Inclusion Criteria

I have smoked at least 10 packs of cigarettes a year in my life.

I am between 45 and 90 years old.

I am a smoker with COPD and know my emphysema level.

See 1 more

Exclusion Criteria

My cancer has spread to other parts of my body.

I am currently on dialysis.

I have had surgery for a leg fracture that involved placing metal parts.

See 3 more

Treatment Details

Interventions

Dual-energy X-ray absorptiometry scan (Diagnostic Test)
Duel-energy X-ray absorptiometry scan (Diagnostic Test)
Multi-detector computed tomography (Diagnostic Test)

Trial OverviewThe study tests a new CT-based tool to assess bone structure and fracture risk in COPD patients at risk for osteoporosis. It involves vital signs checks, urine tests, questionnaires, DXA scans for bone density, blood tests, and multi-detector CT scans.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: BaselineExperimental Treatment7 Interventions

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

Group II: 3 year follow-upExperimental Treatment7 Interventions

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