Skeletal Health in Adolescents with Cystic Fibrosis Study

This study is looking at bone health in adolescents (ages 13-20) with cystic fibrosis (CF). Researchers want to understand if young people with CF have more fat in their bone marrow and how this might affect their bone strength. They will use several imaging tests, including magnetic resonance relaxometry (MRI scans to measure fat in bone marrow), magnetic resonance spectroscopy (another type of MRI to measure fat), DXA (a scan to measure bone density), and pQCT (a scan to measure bone density in the lower leg). Blood tests will also be done to check markers related to bone formation, breakdown, and inflammation. The study aims to see if increased bone marrow fat in CF patients is linked to weaker bones over one year. You may be able to join if you are 13-20 years old, have CF with pancreatic insufficiency, and have been on a stable treatment plan for at least three months.

Study design
This is an observational study planning to enroll 36 adolescents with cystic fibrosis and compare them to healthy individuals. It is not testing a new treatment.
What's involved
Participants will undergo magnetic resonance relaxometry, magnetic resonance spectroscopy, DXA, pQCT scans, and blood draws at the beginning of the study and again after one year.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one year, with assessments at baseline and one year.

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NCT06216704

Skeletal Health and Bone Marrow Composition in Adolescents With Cystic Fibrosis

Recruiting
Not specifiedAges 13–20Observational
Massachusetts General Hospital
~36 participants
Updated 2025-10-30 on ClinicalTrials.gov
What's tested:Magnetic resonance relaxometryMagnetic resonance spectroscopyBlood DrawDXApQCT

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Bone marrow adiposity by magnetic resonance relaxometry (MR relaxometry)
Measured over Baseline and One Year follow-up
+1 more outcome measured
Cystic Fibrosis
1 sites across 1 states
Massachusetts1
  • Rebecca Gordon, MD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital

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Eligibility criteria

Inclusion

13-20 years old
Cystic fibrosis with pancreatic insufficiency
Must have a stable treatment regimen, including CFTR modulator usage unchanged for the prior three months
Liver transplant recipients will be eligible, as long as they are at least 1 year post-transplant and are no longer on Prednisone for immunosuppressive therapy

Exclusion

Diagnosis of other chronic disease affecting bone health
Active use (within the past 3 months) of medications that are known to affect skeletal metabolism
CF exacerbation or glucocorticoid exposure within the prior 1 month
Lung transplant
  • Bone marrow adiposity by magnetic resonance relaxometry (MR relaxometry)Baseline and One Year follow-up

    Change in bone marrow adiposity measured by MR relaxometry

  • Bone marrow adiposity by magnetic resonance spectroscopy (MRS)Baseline and One Year follow-up

    Change in bone marrow adiposity measured by MRS