Crohn'sRecruiting
Skeletal Health and Bone Marrow Composition in Newly Diagnosed Adolescents With Crohn Disease
Observational · No treatment assigned · 1 site · Massachusetts General Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Disease and Crohn Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 13 to 20
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- Crohn's Disease diagnosed within the past 3 months, or a healthy, matched control
There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 92 participants are expected to take part.
- Start date: 2020-09-10.
- Main results expected around 2026-12 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Bone marrow adiposity by magnetic resonance imaging (MRI) (Baseline and One Year follow-up)
In the researchers’ words
The investigators will be evaluating bone marrow composition via magnetic resonance imaging in newly diagnosed adolescents with Crohn disease (CD) 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 and peripheral quantitative computed tomography.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Disease; Crohn Disease |
| Lead sponsor | Massachusetts General Hospital |
| Enrollment | 92 (estimated) |
| Start date | 2020-09-10 |
| Primary completion (est.) | 2026-12 |
| First posted | 2020-08-11 |
| Last updated | 2025-10-30 |
| Official title | Skeletal Health and Bone Marrow Composition in Newly Diagnosed Adolescents With Crohn Disease |
| ClinicalTrials.gov ID | NCT04508088 |
Interventions
- Coronal T1 weighted spin echo images (Diagnostic Test)
Coronal T1 weighted spin echo images will be obtained through the knee with a field of view of 16cm to include distal femoral and proximal tibial metaphyses. - Spin-lattice relaxation (T1) (Diagnostic Test)
Spin-lattice relaxation (T1) relaxometry acquisition consisting of seven fast spin echo (FSE) acquisitions through the knee. T1 maps from the T1 relaxometry images will be generated using a two-parameter-fit iterative algorithm developed in-house using IDL software (Harris Geospatial Solutions, Melbourne, FL, USA). Mean T1 values for each region will be recorded. The anatomical locations of these … - Magnetic resonance spectroscopy (Diagnostic Test)
Magnetic resonance spectroscopy. MRS will be performed within a 1 mL voxel situated in the medial aspect of the distal femoral metaphysis. A single voxel point resolved spectral acquisition (PRESS) technique will be used to acquire non-water suppressed spectra at echo times of 20, 30, 40, and 50 ms using 32 signal averages per echo time with a TR of 2.5 s (total scan time = 5.4 minutes). Spectral … - Blood Draw (Diagnostic Test)
Blood draw. Blood draws will be used to attain and assess markers of bone formation/resorption and to perform immune studies. Specific markers of bone formation that will be assessed include osteocalcin (OC) and procollagen type 1 N-terminal propeptide (P1NP), and a marker of bone resorption, c-telopeptide (CTX). We will also evaluate molecular gene signatures from the blood samples that correlate…
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Boston Children's Hospital | Boston, Massachusetts | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.