Evaluating bone health in adolescents with cystic fibrosis
Skeletal Health and Bone Marrow Composition in Adolescents With Cystic Fibrosis
This study is testing how bone health in teenagers with cystic fibrosis compares to their healthy peers to see if higher fat in their bone marrow affects their bone strength.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 36 (estimated) |
| Ages | 13 Years to 20 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | Prednisone |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06216704 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess bone marrow composition and bone mineral density in adolescents diagnosed with cystic fibrosis (CF) compared to healthy controls. Using advanced imaging techniques such as magnetic resonance imaging, dual-energy X-ray absorptiometry, and peripheral quantitative computed tomography, the study will investigate the relationship between increased bone marrow fat and decreased bone health. The research will focus on understanding the underlying mechanisms affecting bone development in adolescents with CF, particularly during this critical growth period. A total of 36 adolescents with CF will be matched with 36 healthy peers based on various demographic factors.
Who should consider this trial
Good fit: Ideal candidates include adolescents aged 13-20 with cystic fibrosis and pancreatic insufficiency who have a stable treatment regimen.
Not a fit: Patients with other chronic diseases affecting bone health or those currently using medications that alter skeletal metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of bone health in adolescents with cystic fibrosis.
How similar studies have performed: While the specific focus on bone marrow composition in adolescents with cystic fibrosis is novel, related studies have shown varying degrees of success in understanding bone health in CF patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Rebecca Gordon, MD — Boston Children's Hospital
- Study coordinator: Rebecca Gordon, MD
- Email: rebecca.gordon@childrens.harvard.edu
- Phone: (617) 355-7476
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.