Randomized Trial to Investigate Intranasal Oxytocin's Effects on Bone Health in Children with Autism Spectrum Disorder

Autism Spectrum Disorder (ASD) is a neurodevelopmental condition often associated with various comorbidities, including potential physiological differences that may impact overall health. While research has focused on the neurological and behavioral aspects of ASD, less is known about its systemic effects, such as on bone health. Children with ASD may have unique dietary patterns, activity levels, or medication use that could influence bone metabolism. Understanding the potential impact of interventions like oxytocin, which is being explored for social and behavioral aspects of ASD, on bone health is crucial to ensure comprehensive care and avoid unintended side effects.

This is a randomized, double-blind, placebo-controlled study investigating intranasal oxytocin (30 IU, 2 times daily) on bone health in children with Autism Spectrum Disorder, aged 6-18 years. Subjects will receive intranasal oxytocin or placebo for 12 months in the double-blind phase, followed by a 6-month open-label phase where all receive oxytocin. Primary endpoints include assessments of body composition, bone density, and bone structure via imaging. Study visits include baseline, week 2, and months 6, 12, 18, with regular phone calls. Additional assessments include history, physical exams, anthropometric measurements, EKG, adverse event monitoring, and laboratory tests for chemistries, hormones, and bone metabolism biomarkers.