Oxytocin Effects on Bone in Children with Autism Spectrum Disorder

Launched by ELIZABETH AUSTEN LAWSON · Feb 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a hormone called oxytocin, given as a nasal spray, might affect bone health in children with Autism Spectrum Disorder (ASD) who are between 6 and 18 years old. The goal is to see if oxytocin can help improve bone metabolism, which is important for keeping bones strong and healthy. Children participating in the study will be randomly assigned to receive either oxytocin or a placebo (a treatment that has no active ingredients) for 12 months. After this period, everyone in the study will receive oxytocin for an additional 6 months. Throughout the trial, participants will have regular check-ups and assessments, including health exams, lab tests, and imaging studies to monitor their bone health.

To be eligible for this trial, children must be diagnosed with ASD and have a body mass index (BMI) within a specific range. Parents or guardians will need to provide consent for their child to participate, and children who are able to understand the study will need to agree to take part as well. It's important to note that certain medical conditions or medications may exclude a child from joining the study. Overall, this trial aims to gather valuable information on how oxytocin might benefit bone health in children with autism, and the findings could help improve care for this population in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Ages 6 to 18 years old at Randomization
• • 2. BMI greater than or equal to the 5th percentile
• • 3. Expert clinical diagnosis of ASD
• • 4. Availability of parent/guardian to provide informed consent
• Exclusion Criteria:
• • 1. Fragile X, tuberous sclerosis, and other single gene defects that are syndromic
• • 2. Other conditions that may contribute to low bone density (e.g., hypogonadism)
• • 3. Medications that may impact bone other than calcium or vitamin D supplementation
• • 4. Hyponatremia
• • 5. Liver enzymes (AST, ALT, and Bilirubin) more than three times the upper limit of the normal range
• • 6. Estimated glomerular filtration rate (eGFR) less than 60
• • 7. Substance use disorder within the last 6 months
• • 8. History of known coronary artery disease, heart failure, reduced ejection fraction, hypertrophic cardiomyopathy, ventricular arrhythmias, or prolonged QT
• • 9. Active seizures within 6 months preceding the Screening visit or the Baseline visit
• • 10. Subjects who are pregnant, lactating, or who refuse contraception if sexually active
• • 11. Subjects who have had previous treatment with OXT (within 2 months of Randomization)
• • 12. Subjects who are not able to cooperate with medication administration, blood drawing, or imaging procedures despite behavior training
• • 13. Caregivers who are unable to speak English, be consistently present at study visits to report on symptoms or, per the judgement of the data collection team, are unable to comply with the protocol