Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

Oxytocin Effects on Bone in Children With Autism Spectrum Disorder

NCT05754073 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG 1. Intranasal oxytocin spray
  • DRUG 2. Intranasal placebo spray
  • DRUG 3. Intranasal Oxytocin spray

Study Locations (2)

Massachusetts

  • Massachusetts General Hospital — Boston

Virginia

  • University of Virginia Medical Center — Charlottesville

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2023-08-01
Est. Completion 2028-08-31
Phase Phase 2

Sponsor

Elizabeth Austen Lawson

34 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05754073

The ClinicalTrials.gov registry entry for NCT05754073 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Elizabeth Austen Lawson, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 3 interventions — of which 1. Intranasal oxytocin spray is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05754073 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Massachusetts, Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05754073 about?

NCT05754073 is a clinical study titled "Oxytocin Effects on Bone in Children With Autism Spectrum Disorder". 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-b...

What is the current status of trial NCT05754073?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2023-08-01. Estimated completion is 2028-08-31.

What conditions does trial NCT05754073 study?

This clinical trial studies the following conditions: Autism Spectrum Disorder, Bone Health. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05754073?

The interventions under investigation include: 1. Intranasal oxytocin spray (DRUG), 2. Intranasal placebo spray (DRUG), 3. Intranasal Oxytocin spray (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05754073?

This trial is sponsored by Elizabeth Austen Lawson, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05754073 being conducted?

This trial has 2 study locations across Massachusetts, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial