NCT05754073RecruitingPhase 2
Oxytocin Effects on Bone in Children With Autism Spectrum Disorder
A Randomized, Double-blind, Placebo-controlled Study of Intranasal Oxytocin for Bone Health in Children With Autism Spectrum Disorder
Source: ClinicalTrials.gov · Last updated 2 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- First submitted
- 22 Feb 2023
- Start date
- 1 Aug 2023
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Elizabeth Austen Lawson
- Diseases
- Autism
- NCT number
- NCT05754073
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 96
- From 1 Aug 2023 to the primary completion date, 31 Aug 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- 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)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 6 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of Virginia Medical Center Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.