Cystic Fibrosis Clinical Trial
Official title:
Skeletal Health and Bone Marrow Composition in Adolescents With Cystic Fibrosis
The investigators will be evaluating bone marrow composition via magnetic resonance imaging in adolescents diagnosed with cystic fibrosis (CF) compared to healthy, matched controls. The investigators will also be assessing their bone mineral density via other imaging modalities, including dual-energy X-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT). This longitudinal project will focus on abnormalities in bone marrow composition, and specifically whether adolescents with diagnosed with CF exhibit increased bone marrow fat, its association with bone mineral density (BMD) and the underlying pathophysiology, including glycemic control, inflammation, and bone turnover markers.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | June 30, 2029 |
Est. primary completion date | December 31, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 20 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital | Cystic Fibrosis Foundation |
United States,
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* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone marrow adiposity by magnetic resonance relaxometry (MR relaxometry) | Change in bone marrow adiposity measured by MR relaxometry | Baseline and One Year follow-up | |
Primary | Bone marrow adiposity by magnetic resonance spectroscopy (MRS) | Change in bone marrow adiposity measured by MRS | Baseline and One Year follow-up | |
Secondary | Total body bone mineral density Z-score by Dual-energy X-ray absorptiometry (DXA) | Change in total body less head BMD Z-score | Baseline and One Year follow-up | |
Secondary | Spine BMD Z-score by DXA | Change in lumbar spine BMD Z-score | Baseline and One Year follow-up | |
Secondary | Hip BMD Z-score by DXA | Change in hip BMD Z-score | Baseline and One year follow-up | |
Secondary | Volumetric bone mineral density (vBMD) | Change in quantitative computed tomography (pQCT) scans will be obtained at the left tibia | Baseline and One Year follow-up | |
Secondary | polar strength strain index | Change in pQCT bone strength measure | Baseline and One Year follow-up | |
Secondary | osteocalcin | Change in bone formation assessed by osteocalcin (ng/mL) | Baseline and One Year follow-up | |
Secondary | procollagen type 1 N-terminal propeptide | Change in bone formation assessed by procollagen type 1 N-terminal propeptide (ng/mL) | Baseline and One Year follow-up | |
Secondary | c-telopeptide | Change in bone resorption assessed by c-telopeptide (pg/ml) | Baseline and One Year follow-up |
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