← Back to Search

Diagnostic Test

CT-Based Bone Assessment for Fracture Risk in COPD

N/A

Waitlist Available

Led By Punam Saha, PhD

Research Sponsored by Punam Saha

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current or former smoker, defined as having at least 10-pack year lifetime history

Age: 45-90

Must not have

Metastatic Malignancy

Currently receiving dialysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline and three year follow up visit

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new tool to assess osteoporosis and bone loss in COPD patients, which may be more accurate than existing methods. The study will look at how different factors related to COPD impact bone structure and the risk of fractures.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

There are no direct side effects from the interventions as they are non-invasive diagnostic procedures. However, there may be minimal risks associated with exposure to radiation during scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am between 45 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My cancer has spread to other parts of my body.

Select...

I am currently on dialysis.

Select...

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

Select...

I have had fractures in both of my shins.

Select...

I have had a leg or foot fracture in the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline and three year follow up visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline and three year follow up visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline and three year follow up visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CT-based fracture-risk

DXA-based fracture risk

Incident vertebral fractures

+1 more

Secondary study objectives

Ankle

CT bone mineral density at the spine

DXA Bone Mineral Density

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vital signs

2017

Completed Phase 3

~810

Urine Pregnancy Test

2018

N/A

~310