Could a nasal spray strengthen bones in kids with autism?
NCT ID NCT05754073
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether a nasal spray containing oxytocin, a natural hormone, can improve bone health in children with autism spectrum disorder (ASD) aged 6 to 18. Participants will receive either oxytocin or a placebo spray twice daily for 12 months, followed by 6 months where everyone gets oxytocin. The goal is to see if oxytocin can increase bone density and strength, which is often lower in children with ASD.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 96 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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, William's syndrome, Angelman's syndrome, Noonan syndrome, and other single gene defects that are syndromic and affect heart or bone density 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, other than calcium or vitamin D supplementation, such as specific anti-seizure medications (Phenytoin, Phenobarbital), oral glucocorticoids, hormonal contraceptive injection (Medroxyprogesterone acetate (Depo-Provera) 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 (QTc greater than or equal to 480 msec) 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 14. Any significant illness, condition, medication, or medical device that the Investigator determines could interfere with study participation and impact data collection or subject safety
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
Contact Email: •••••@•••••
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University of Virginia Medical Center
RECRUITINGCharlottesville, Virginia, 22903, United States
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Other studies related to the condition(s) this trial covers.
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- Can an AI chatbot help autism caregivers find their way?
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