Tests oxytocin nasal spray for bone health in children with autism
Tests oxytocin nasal spray against placebo for bone health in children with autism.
Plain-language title generated from the registry record
Registry title: Oxytocin Effects on Bone in Children With Autism Spectrum Disorder
Key facts
- Where
- Boston and Charlottesville, United StatesSee the 2 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 18 years old?
Source: NCT05754073, who can take part
Where in United States
- Massachusetts General HospitalBoston, United StatesTaking people
- University of Virginia Medical CenterCharlottesville, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Elizabeth Austen Lawson
- Trial code
- NCT05754073
- Record updated
- 2 March 2026
- Original description
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.Read full original descriptionShow less
A Randomized, Double-blind, Placebo-controlled Study of Intranasal Oxytocin for Bone Health 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-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.
Inclusion: 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.
Exclusion: Subjects who have had previous treatment with OXT (within 2 months of Randomization); Subjects who are not able to cooperate with medication administration, blood drawing, or imaging procedures despite behavior training; 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); Substance use disorder within the last 6 months; Active seizures within 6 months preceding the Screening visit or the Baseline visit; Any significant illness, condition, medication, or medical device that the Investigator determines could interfere with study participation and impact data collection or subject safety; 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); Liver enzymes (AST, ALT, and Bilirubin) more than three times the upper limit of the normal range; Estimated glomerular filtration rate (eGFR) less than 60; History of known coronary artery disease, heart failure, reduced ejection fraction, hypertrophic cardiomyopathy, ventricular arrhythmias, or prolonged QT (QTc greater than or equal to 480 msec); Hyponatremia; Subjects who are pregnant, lactating, or who refuse contraception if sexually active; 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.