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Skeletal Health and Bone Marrow Composition in Newly Diagnosed Adolescents With Crohn Disease
NCT04508088 · Massachusetts General Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
Less than optimal bone health has been seen in children that have inflammatory bowel disease (IBD), including Crohn disease (CD). This can present as low bone density or altered bone structure, weakening the bones and increasing fragility and fracture risk. As adolescence is especially important in bone development, conditions such as CD during this time can lead to long term bone issues. The underlying mechanisms are not well understood, but what is known is that red bone marrow converts to fat-rich yellow marrow. This study aims to focus on abnormalities in bone marrow, and specifically whether adolescents who have been diagnosed with CD have more bone marrow fat.
The primary hypothesis is that newly diagnosed CD is associated with increased fat levels in bone, which is associated with decreased bone formation and suboptimal bone health. The central objective is to obtain longitudinal data on the differences in bone marrow between healthy adolescents and those with CD. Long term, the investigators want to study how abnormal fat tissue and suboptimal bone health relate to each other.
The study involves 46 adolescents recently diagnosed with CD and 46 healthy adolescents. Eligibility criteria include no other chronic diseases that affect bone health and limited use of bone altering medications in the last three months. The CD adolescents will be matched with healthy adolescents based on age, stage of puberty, and BMI percentile. Additional data on CD participants will be collected via a chart review that will enable us to more fully characterize their CD.
Imaging will include MRIs of the knee. Measurements will include a visual assessment and quantitative marrow fat analysis, dual-energy X-ray absorptiometry (DXA), and peripheral quantitative computed tomography (pQCT). All scans will be for research purposes only. The MRIs will be evaluated for any abnormalities, and if there is an incidental finding, it will be reported to the primary care physician.
Additionally, blood draws will be used to attain and assess markers of bone formation/resorption and to perform immune studies.
Eligibility criteria
Inclusion Criteria:
* Crohn's Disease diagnosed within the past 3 months, or a healthy, matched control
Exclusion Criteria:
* Participants with chronic disease known to affect skeletal metabolism
* Participants on certain medications within the prior 3 months that are known to affect skeletal metabolism
* Participants who are pregnant
* Participants who have a history of: claustrophobia, internal body metal that is not compatible with MRI machine, or a known abnormality on or adjacent to the left knee
Study design
Enrollment target: 92 participants
Age groups: child, adult
Timeline
Starts: 2020-09-10
Estimated completion: 2026-12
Last updated: 2025-10-30
Interventions
Diagnostic Test: Coronal T1 weighted spin echo imagesDiagnostic Test: Spin-lattice relaxation (T1)Diagnostic Test: Magnetic resonance spectroscopyDiagnostic Test: Blood Draw
Primary outcomes
- • Bone marrow adiposity by magnetic resonance imaging (MRI) (Baseline and One Year follow-up)
- • Magnetic resonance spectroscopy (MRS) (Baseline and One Year follow-up)
Sponsor
Massachusetts General Hospital · other
Contacts & investigators
ContactRebecca Gordon, MD · contact · rebecca.gordon@childrens.harvard.edu · (617) 355-7476
InvestigatorRebecca Gordon, MD · principal_investigator, Boston Children's Hospital
All locations (1)
Boston Children's HospitalRecruiting
Boston, Massachusetts, United States