Skeletal Health and Bone Marrow Composition in Adolescents With Cystic Fibrosis

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06216704
Status
Recruiting
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Conditions

  • Cystic Fibrosis

Eligibility Criteria

Sex
ALL
Age
13 Years - 20 Years
Healthy Volunteers
Accepted

Interventions

  • Magnetic resonance relaxometry — DIAGNOSTIC_TEST
    Spin-lattice relaxation (T1) relaxometry acquisition consisting of 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 multiple echo times. 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 inflammation. 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). Additionally, in participants with CF, we will assess inflammation, with a c-reactive protein (CRP), and dysglycemia, with a continuous glucose monitor.
  • DXA — DIAGNOSTIC_TEST
    DXA will be utilized to obtain BMD of the total body, lumbar spine, and hip using a Hologic Horizon densitometer (Hologic Inc, Bedford, MA). Body composition will be obtained from total body scans.
  • pQCT — DIAGNOSTIC_TEST
    pQCT will be utilized to obtain volumetric BMD (mg/cm3) of the left tibia. Measurements using a Stratec XCT 3000 device (Orthometrix, White Plains, NY) will be obtained at multiple locations, in relation to distal growth plate.

Study Details

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.

Key Dates

Start date
Apr 1, 2024
Status verified
Oct 2025
Primary completion
Dec 31, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
36 participants (estimated)

Arms

  • Arm: Cystic Fibrosis
    This group will be 36 adolescents, ages 13-20 years old, who have been diagnosed with cystic fibrosis. 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, BMI percentile, and ancestry. 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 relaxometry (MR relaxometry) [ Time Frame: Baseline and One Year follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Rebecca Gordon, MD
[email protected]
Rebecca Gordon, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Boston Children's Hospital· Boston, MA

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