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Oxytocin Effects on Bone in Children With Autism Spectrum Disorder

Study acronym: BOX
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Eligibility criteria expanded, about 12 wordsv8
  2. Primary completion date: Oct 31, 2025 to Aug 31, 2027v7 Show 5 more changesShow less
    • Primary endpoint revised
    • Study completion date: Oct 31, 2026 to Aug 31, 2028
    • Eligibility criteria expanded, about 54 words
    • Secondary endpoints: 4 to 5
    • Site contacts updated at 2 of 2 sites
  3. Lead sponsor: Massachusetts General Hospital to Elizabeth Austen Lawsonv6 Show 6 more changesShow less
    • Primary endpoint revised
    • Study sites: 1 to 2
    • Eligibility criteria shortened, about 36 words
    • Secondary endpoints revised (4)
    • Collaborators: 1 to 2
    • Study title shortened, about 1 word
  4. Re-verified, no change to tracked fieldsv5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jul 1, 2023 to Aug 1, 2023
    • Site details revised
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Apr 1, 2023 to Jul 1, 2023v3
  2. Primary endpoint revised
    • Secondary endpoints revised (4)
    • Study description expanded, about 1 word
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin on bone health in children with autism spectrum disorder, ages 6-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (30 IU, 2 times daily) for 12 months in the double-blind phase, followed by a 6-month open label phase during which all study subjects will receive intranasal oxytocin (30 IU, 2 times daily). Study visits include screening to determine eligibility, followed by study visits at baseline, week 2, and months 6, 12, 18 and phone calls every two weeks for the first two months and monthly thereafter for the duration of the study. Study assessments include history and physical examinations, anthropometric measurements, electrocardiogram (EKG), adverse event monitoring, laboratory tests for chemistries, hormones and biomarkers for bone metabolism, questionnaires regarding diet and exercise, and imaging to assess body composition, bone density and structure.
Trial Details
NCT Number NCT05754073
Lead Sponsor Elizabeth Austen Lawson
Collaborators: United States Department of Defense, University of Virginia
Conditions
(from sponsor)		 Autism Spectrum Disorder, Bone Health
Related terms Autism Spectrum Disorder
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov