36 Participants Needed

Bone Health Assessment for Cystic Fibrosis

RG
Overseen ByRebecca Gordon, MD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Boston Children's Hospital
Must be taking: CFTR modulators
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the relationship between bone health and cystic fibrosis in teenagers. Researchers aim to determine if adolescents with cystic fibrosis have increased bone marrow fat and how it might affect their bone strength and overall health. Various imaging techniques will measure bone marrow and density. The study seeks teenagers aged 13 to 20 with cystic fibrosis and pancreatic insufficiency who have not changed their treatment in the last three months. As an unphased study, this trial offers a unique opportunity to enhance understanding of bone health in cystic fibrosis, potentially benefiting future treatments.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover important insights into skeletal health and bone marrow composition in adolescents with cystic fibrosis. Unlike existing treatments that primarily focus on managing lung function and nutritional status, this study investigates how cystic fibrosis impacts bone health, a less understood aspect of the condition. By comparing adolescents with cystic fibrosis to a control group matched for age and other factors, the trial hopes to identify potential differences or changes in bone and marrow health over time. This could lead to new strategies for improving overall health outcomes in young people with cystic fibrosis.

Who Is on the Research Team?

RG

Rebecca Gordon, MD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

You are between 13 and 20 years old.
You have cystic fibrosis and your pancreas doesn't work properly.
You can join the study if you had a liver transplant at least 1 year ago and are not taking Prednisone anymore for immunosuppressive therapy.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial imaging and blood tests to assess bone marrow composition and bone mineral density

1 day
1 visit (in-person)

Follow-up

Participants are monitored for changes in bone marrow composition and bone mineral density

1 year
1 visit (in-person)

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Cystic FibrosisExperimental Treatment5 Interventions
Group II: ControlExperimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Cystic Fibrosis Foundation

Collaborator

Trials
199
Recruited
37,800+