Skeletal Health and Bone Marrow Composition in Newly Diagnosed Adolescents With Crohn Disease

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04508088
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
13 Years - 20 Years
Healthy Volunteers
Accepted

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 regions will be consistent in size for all subjects and location. The locations chosen for the primary endpoints are ones that are known to be rich in red and yellow marrow, respectively.
  • 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 fits using JMRUI MRS processing software (www.jmrui.eu) to the water and methylene/methyl resonances will be used to quantify peak areas and establish T2 corrected fat/(fat + water) ratios.
  • 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 with the previously described bone imaging phenotypes. At that point, the information will be used to develop a CyTOF panel to evaluate differences in immune cellular populations between CD patients with normal versus low BMD, and matched controls.

Study Details

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 longitudinal project will focus on abnormalities in bone marrow composition, and specifically whether adolescents with newly diagnosed CD exhibit increased bone marrow fat, its association with bone mineral density (BMD) and the underlying pathophysiology, including bone turnover markers and immune cellular/molecular parameters.

Key Dates

Start date
Sep 10, 2020
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
92 participants (estimated)

Arms

  • Arm: Crohn Disease
    This group will be 46 adolescents, ages 13-20, who have been recently (within 3 months) diagnosed with Crohn Disease. All participants will have a two study visits approximately one year apart during which the listed diagnostic testing will be performed.
  • Arm: Control
    Controls will be matched for age, Tanner staging, and BMI percentile. All participants will have a two study visits approximately one year apart during which the listed diagnostic testing will be performed.

Primary Outcome Measure

Bone marrow adiposity by magnetic resonance imaging (MRI) [ Time Frame: Baseline and One Year follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Rebecca Gordon, MD

Find similar trials in Boston, MA

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Boston Children's Hospital· Boston, MA

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