CT-Based Bone Assessment for Fracture Risk in COPD

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Punam Saha

Disqualifiers: Pregnant, Metastatic malignancy, Dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

560 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment for fracture risk in COPD?

Research shows that using CT scans to assess bone density and fractures in COPD patients can help identify those at higher risk of fractures. Dual-energy X-ray absorptiometry (DXA) and quantitative computed tomography (QCT) are effective in detecting osteoporosis, with QCT being more sensitive in identifying low bone mineral density in COPD patients. ^{1 2 3 4 5}

Is CT-based bone assessment safe for humans?

CT scans and dual-energy X-ray absorptiometry (DXA) are generally considered safe imaging techniques for assessing bone health. They are commonly used in medical practice to evaluate bone density and fracture risk, with minimal risk to patients. ^{3 4 6 7 8}

How does CT-based bone assessment for fracture risk in COPD differ from other treatments?

CT-based bone assessment for fracture risk in COPD is unique because it uses advanced imaging techniques like dual-energy X-ray absorptiometry (DXA) and multi-detector computed tomography (CT) to evaluate bone health, which can provide more detailed information about bone density and structure compared to traditional methods. This approach is particularly useful in identifying osteoporosis in COPD patients, as it can detect bone issues that other methods might miss, such as those obscured by aortic calcifications or spinal changes. ^{1 3 4 9 10}

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.

Research Team

Punam Saha, PhD

Principal Investigator

University of Iowa

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including vital signs, spirometry, questionnaires, blood tests, DXA scans, and CT scans

1 visit

1 visit (in-person)

3-Year Follow-up

Participants return for follow-up assessments including vital signs, spirometry, questionnaires, blood tests, DXA scans, and CT scans

3 years

1 visit (in-person)

Follow-up

Participants are monitored for changes in bone mineral density and fracture risk

4 weeks

Treatment Details

Interventions

• Dual-energy X-ray absorptiometry scan
• Duel-energy X-ray absorptiometry scan
• Multi-detector computed tomography

Trial Overview 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.

Participant Groups

Group I: Baseline Experimental Treatment 7 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-up Experimental Treatment 7 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

Who Is Running the Clinical Trial?

Punam Saha

Lead Sponsor

Trials

1

Recruited

560+

Punam K Saha

Lead Sponsor

Trials

1

Recruited

560+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

References

1. Egypt pubmed.ncbi.nlm.nih.gov

Assessment of Bone Mineral Density in Male Patients with Chronic Obstructive Pulmonary Disease by DXA and Quantitative Computed Tomography. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

COPD and osteoporosis: detection and grading of vertebral fractures on lateral chest radiography. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Vertebral bone attenuation in Hounsfield Units and prevalent vertebral fractures are associated with the short-term risk of vertebral fractures in current and ex-smokers with and without COPD: a 3-year chest CT follow-up study. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Bone stiffness and failure load are related with clinical parameters in men with chronic obstructive pulmonary disease. [2013]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Management of Fracture Risk in Patients with Chronic Obstructive Pulmonary Disease (COPD): Building a UK Consensus Through Healthcare Professional and Patient Engagement. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Osteoporosis in COPD outpatients based on bone mineral density and vertebral fractures. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Theoretical feasibility of dual-energy radiography for structural and functional imaging of chronic obstructive pulmonary disease. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Skeletal Implications of Chronic Obstructive Pulmonary Disease. [2018]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Ten-year risk of osteoporotic fractures in patients with chronic obstructive pulmonary disease estimated by FRAX method]. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Bone attenuation on routine chest CT correlates with bone mineral density on DXA in patients with COPD. [2021]