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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline and three year follow up visit
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have smoked at least 10 packs of cigarettes a year in my life.
Select...
I am between 45 and 90 years old.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CT-based fracture-risk
DXA-based fracture risk
Incident vertebral fractures
+1 moreSecondary outcome measures
Ankle
CT bone mineral density at the spine
DXA Bone Mineral Density
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
Blood Test
2010
N/A
~320
Find a Location
Who is running the clinical trial?
Punam SahaLead Sponsor
Punam K SahaLead Sponsor
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,019 Total Patients Enrolled
10 Trials studying Osteoporosis
1,669 Patients Enrolled for Osteoporosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to other parts of my body.I have smoked at least 10 packs of cigarettes a year in my life.I am between 45 and 90 years old.I am currently on dialysis.I have had surgery for a leg fracture that involved placing metal parts.I am a smoker with COPD and know my emphysema level.I have had fractures in both of my shins.I am a smoker and will be grouped based on whether I have COPD.I have had a leg or foot fracture in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Baseline
- Group 2: 3 year follow-up
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical research project admit individuals aged 35 or older?
"The trial's enrolment requirements state that any hopeful patient must be between 45 and 90 years old. Separately, there are 22 studies for minors and 361 trials specifically designed for patients over 65."
Answered by AI
Do the requirements for this trial align with my qualifications?
"This medical trial is accepting 560 participants, aged between 45 and 90, diagnosed with osteoporosis. Additionally, the inclusion criteria necessitates that all candidates must be either current or former smokers who have accumulated at least 10-pack year lifetime history."
Answered by AI
Are there any vacancies left in this clinical trial?
"According to information on clinicaltrials.gov, enlistment for this trial has closed; the original posting was made February 26th 2019 and the listing was last edited August 2nd 2022. Despite its cessation of recruitment, there are still 383 other trials that are actively welcoming patients at present."
Answered by AI
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