Health TrialsbyHealthPanel

Oxytocin Effects on Bone in Children With Autism Spectrum Disorder

ConditionsAutism Spectrum DisorderBone Health
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-18
SponsorElizabeth Austen Lawson

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ages 6 to 18 years old at Randomization

BMI greater than or equal to the 5th percentile

Expert clinical diagnosis of ASD

Availability of parent/guardian to provide informed consent

Disqualifiers

Fragile X, tuberous sclerosis, William's syndrome, Angelman's syndrome, Noonan syndrome, and other single gene defects that are syndromic and affect heart or bone density

Other conditions that may contribute to low bone density (e.g., hypogonadism)

Medications that may impact bone other than calcium or vitamin D supplementation, other than calcium or vitamin D supplementation, such as specific anti-seizure medications (Phenytoin, Phenobarbital), oral glucocorticoids, hormonal contraceptive injection (Medroxyprogesterone acetate (Depo-Provera)

Hyponatremia

Trial design

Design model

Parallel

Treatments tested in this trial

  • 1. Intranasal oxytocin spray

    Drug

    30 IU, twice daily for 12 months in the experimental arm in double-blinded phase

  • 2. Intranasal placebo spray

    Drug

    30 IU, twice daily for 12 months in the placebo comparator arm in double-blinded phase

  • 3. Intranasal Oxytocin spray

    Drug

    30 IU, twice daily for 6 months in both experimental and placebo comparator arm in open-label phase

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: 1. Intranasal OxytocinExperimental treatment 2 interventions
Group B: 2. PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Difference between IN OXT vs placebo in 12-month change in whole body less head BMD Z-scores.

Time frame
12 months

Secondary outcomes

1

Difference between IN OXT vs placebo in 12-month change in areal BMD Z-score at the femoral neck.

Time frame
12 months
2

Difference between IN OXT vs placebo in 12-month change in radial and tibial cortical area and radial trabecular thickness.

Time frame
12 months
3

Difference between IN OXT vs placebo in 12-month change in radial and tibial failure load.

Time frame
12 months
4

Difference between IN OXT vs placebo in 12-month change in bone turnover markers, cortisol.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Elizabeth Austen Lawson

Lead sponsor

Massachusetts General Hospital

Sponsor institution

United States Department of Defense

Collaborator

University of Virginia

Collaborator

Source ClinicalTrials.gov
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