Oxytocin Effects on Bone in Children With Autism Spectrum Disorder

What Was Tested

The trial (phase 2) is built around Oxytocin.

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.

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.

It had two arms (groups): 1. Intranasal Oxytocin (experimental) and 2. Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

ASD is also characterized by low levels of oxytocin (OXT), a peptide hormone with prosocial effects.

The investigators will enroll 96 participants 6-18 years old with ASD and randomize them into the intranasal oxytocin vs. placebo groups.

The study subjects will undergo 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.

Who Took Part

The registry lists 96 planned participants were the target.

It was open to people of any sex aged from 6 years up to 18 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: 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); liver enzymes (ast, alt, and bilirubin) more than three times the upper limit of the normal range.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Oxytocin group and the comparison group ran side by side rather than switching.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2023-08-01 with completion listed for 2027-08-31.

It ran at 2 sites in United States (2).

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Difference between IN OXT vs placebo in 12-month change in whole body less head BMD Z-scores (time frame: 12 months).

It also tracked 5 secondary outcomes, for example Difference between IN OXT vs placebo in 12-month change in areal BMD Z-score at the femoral neck, Difference between IN OXT vs placebo in 12-month change in radial and tibial cortical area and radial trabecular thickness, Difference between IN OXT vs placebo in 12-month change in radial and tibial failure load, Difference between IN OXT vs placebo in 12-month change in bone turnover markers, cortisol and Difference between IN OXT vs placebo in 12-month change in lean mass and muscle area.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 96 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.