CT-Based Bone Assessment for Fracture Risk in COPD

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assess bone health and fracture risk in individuals with COPD, a lung disease. Researchers use advanced CT scans, including dual-energy X-ray absorptiometry scans, to examine bone structure rather than just bone density. The goal is to develop a model that more accurately predicts fracture risk specifically for those with COPD. Smokers, both with and without COPD, who have smoked the equivalent of a pack a day for at least ten years may be suitable candidates for this trial. As an unphased study, this trial allows participants to contribute to groundbreaking research that could improve health outcomes for those with COPD.

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 prior data suggests that this CT-based tool is safe for assessing fracture risk in COPD patients?

Research has shown that dual-energy X-ray absorptiometry (DXA) safely and effectively checks bone health, especially in people with COPD. DXA scans measure bone density and can detect bone loss. Studies indicate that patients tolerate DXA well, with no significant side effects reported.

Similarly, multi-detector computed tomography (MDCT) reliably provides detailed images of the body, including bones. MDCT is commonly used in medical settings and is considered safe. It allows doctors to examine bone structure without surgery. Research has not identified any major safety concerns with its use.

Both DXA and MDCT are non-invasive imaging methods and are generally considered safe for humans, with minimal risk involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's using advanced imaging techniques to better understand fracture risk in people with COPD, a condition not traditionally linked with bone health. Unlike standard methods like simple X-rays or just monitoring symptoms, this study uses dual-energy X-ray absorptiometry (DXA) and multi-detector computed tomography (MDCT) to get detailed images of bones. These methods can provide a more comprehensive assessment of bone density and structure, potentially leading to earlier and more accurate detection of fracture risk. This could pave the way for more personalized treatment plans and improve quality of life for those with COPD.

What evidence suggests that this CT-based tool is effective for assessing fracture risk in COPD patients?

Research has shown that DXA scans, which participants in this trial will undergo, effectively measure bone strength in people with COPD. These scans help detect osteoporosis, a condition that increases the likelihood of bone fractures. Studies indicate that people with COPD often have weaker bones, raising their fracture risk.

Additionally, CT scans, another assessment tool used in this trial, provide a detailed view of bone structure, aiding in fracture risk prediction. Research has found that this type of CT scan can effectively identify those at higher risk for fractures in COPD patients. Together, these tools offer a clearer understanding of bone health and fracture risk in people with COPD. ^{6 7 8 9 10}

Who Is on the Research Team?

Punam Saha, PhD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4819104/

Assessment of Bone Mineral Density in Male Patients with ... The purpose of this study is to identify the prevalence of osteoporosis in male patients with chronic obstructive pulmonary disease (COPD) by dual-energy X-ray ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1076633224006020

A Novel CT-Based Fracture Risk Prediction Model for ... The aim of this study was to develop and validate a novel computed tomography (CT)-based fracture risk assessment model (FRCT) specifically tailored for ...

3. publications.ersnet.org publications.ersnet.org/content/erj/34/1/209

Current status of research on osteoporosis in COPD One of the outcomes had to be the prevalence of osteoporosis based on bone mineral density (BMD) measurements, thereby excluding studies with a prevalence of ...

4. atsjournals.org atsjournals.org/doi/10.1513/AnnalsATS.201412-591OC

Reduced Bone Density and Vertebral Fractures in Smokers ... Inadequate data regarding fracture risk in men may be compounded by use of dual-energy X-ray absorptiometry (DXA) as the measurement standard, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3263743/

Recommendations for Diagnosis and Management of ... The purpose of this paper is to review the current recommendations for diagnosis and management of osteoporosis in COPD men.

6. publications.ersnet.org publications.ersnet.org/content/erj/19/4/626

Bedside methods versus dual energy X‐ray absorptiometry for ... Abstract. The measurement of body composition is of value in the nutritional assessment of patients with chronic obstructive pulmonary disease (COPD).

7. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(23)00772-4/pdf

Dual-energy X-ray absorptiometry in the clinical evaluation ... Design: In a cross-sectional study in 79 COPD patients partici- pating in a pulmonary inpatient program and in 23 healthy vol- unteers, DXA was compared with ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01388920

Efficacy and Safety Study of Tesamorelin in Chronic ... The primary objective of this study is to investigate the effect of tesamorelin, in conjunction with exercise training, on lean body mass measured by dual ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/9846862/

Dual-energy X-ray absorptiometry in the clinical evaluation ... DXA appears to be a suitable alternative method to Deu for assessing body composition and is also of value in identifying bone mineral loss in COPD patients.

10. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/12006428/

Dual energy X-ray absorptiometry outcomes in male COPD ... Dual energy x-ray absorptiometry scanning of the lumbar spine, total hip, and femoral neck regions revealed a T score < or = 2.5 SD in 27 patients (31%), 31 ...