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NCT04508088

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

StatusRecruiting
PhaseNot specified
Primary completion (estimated)
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Record History

All 9 versions: 6 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 5 words Show 4 more changesShow less
    • Study completion pushed from Dec 2026 to Dec 2027
    • Secondary endpoints: details revised at 5 of 12 entries
    • Site details revised
    • Publications: details revised at 53 of 53 entries
  2. Lead sponsor: Boston Children's Hospital to Massachusetts General Hospitalv8
  3. Primary and study completion dates: Dec 2024 to Dec 2026v7
  4. Enrollment target: 20 to 92v4 Show 7 more changesShow less
    • Primary and study completion dates: Aug 2022 to Dec 2024
    • Eligibility criteria shortened, about 9 words
    • Interventions: Coronal T1 weighted spin echo images (Diagnostic Test), Magnetic resonance spectroscopy (Diagnostic Test), Spin-lattice relaxation (T1)… to Blood Draw (Diagnostic Test), Coronal T1 weighted spin echo images (Diagnostic Test), Magnetic resonance spectroscopy (Diagnostic Test)…
    • Secondary endpoints: 8 to 12
    • Study description expanded, about 13 words
    • Publications: 54 to 53
    • Study title shortened, about 1 word
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 2020 to Sep 10, 2020
    v2
  6. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Bone marrow adiposity by magnetic resonance imaging (MRI)
Timeframe: Baseline and One Year follow-up
Magnetic resonance spectroscopy (MRS)
Timeframe: Baseline and One Year follow-up

Secondary (12)

Total body bone mineral density Z-score by Dual-energy X-ray absorptiometry (DXA)
Spine BMD Z-score by DXA
Spine apparent density Z-score by DXA
Volumetric bone mineral density (vBMD)
Bone strength by quantitative computed tomography pQCT
Show 7 moreShow less
Bone Formation Marker #1
Bone Formation Marker #2
Bone Resorption Marker
Immune Studies
Current Crohn's Disease Activity
Physical Activity
Dietary Calcium Intake

Arms and interventions

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.

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.

Diagnostic tests: Coronal T1 weighted spin echo images, Spin-lattice relaxation (T1), Magnetic resonance spectroscopy, Blood Draw

Sites

1 site in 1 country

  • Boston Children's HospitalBoston, Massachusetts, United States