Current partner codePEPTIDESDE
PeptideStat
Menu

Vendors

Compare pricesVendor directoryVendor reviewsDiscount codesLab tests & COAs

Research

ResearchDatabaseClinical trials

Tools

All calculatorsReconstitutionAccumulationUnit converterPeptide chemistry
NCT05754073·Phase 2·INTERVENTIONAL

Oxytocin Effects on Bone in Children With Autism Spectrum Disorder

OxytocinOtherRecruiting

Status

Recruiting

Phase

Phase 2

Enrollment

96

Locations

2

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

The prevalence of autism spectrum disorder (ASD), a group of behaviorally-defined disorders characterized by impaired social interactions and verbal and non-verbal communication, is increasing among children. Studies have shown that children with ASD are at a higher risk for low bone mineral density and fractures. ASD is also characterized by low levels of oxytocin (OXT), a peptide hormone with prosocial effects. In addition, OXT promotes bone formation over resorption and low levels of OXT are associated with poor bone health. Hence, OXT administration represents a potential strategy for improving bone health in children with ASD, particularly during the childhood and adolescent years when bone accrual peaks. The investigators aim to examine (i) whether intranasal OXT administration vs. placebo increases areal bone mineral density (BMD) and improves overall bone health in children with ASD, and (ii) other pathways whereby OXT may impact bone health favorably. The investigators will enroll 96 participants 6-18 years old with ASD and randomize them into the intranasal oxytocin vs. placebo groups. The study subjects will undergo 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.

Interventions

Treatment arms and agents.

DRUG

1. Intranasal oxytocin spray

30 IU, twice daily for 12 months in the experimental arm in double-blinded phase

DRUG

2. Intranasal placebo spray

30 IU, twice daily for 12 months in the placebo comparator arm in double-blinded phase

DRUG

3. Intranasal Oxytocin spray

30 IU, twice daily for 6 months in both experimental and placebo comparator arm in open-label phase

Timeline

From registration to results.

  1. First posted

    Mar 3, 2023

  2. Study start

    Aug 1, 2023

  3. Primary completion

    Aug 31, 2027

  4. Study completion

    Aug 31, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Mar 2, 2026

Outcomes

What the study measures.

Primary outcomes

Difference between IN OXT vs placebo in 12-month change in whole body less head BMD Z-scores.

Time frame · 12 months

Secondary outcomes

Difference between IN OXT vs placebo in 12-month change in areal BMD Z-score at the femoral neck.

Time frame · 12 months

Difference between IN OXT vs placebo in 12-month change in radial and tibial cortical area and radial trabecular thickness.

Time frame · 12 months

Difference between IN OXT vs placebo in 12-month change in radial and tibial failure load.

Time frame · 12 months

Difference between IN OXT vs placebo in 12-month change in bone turnover markers, cortisol.

Time frame · 12 months

Difference between IN OXT vs placebo in 12-month change in lean mass and muscle area

Time frame · 12 months

Eligibility

Who can take part.

Minimum age
6 Years
Maximum age
18 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

2 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Oxytocin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsOxytocin trial dashboard →