- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05754073
Oxytocin Effects on Bone Metabolism 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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Madhusmita Misra, MD, MPH
- Phone Number: 617-726-5790
- Email: mmisra@mgh.harvard.edu
Study Contact Backup
- Name: Sarah Smith, DNP
- Phone Number: 617-726-9394
- Email: ssmith133@mgh.harvard.edu
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
-
Contact:
- Sarah Smith, DNP
- Phone Number: 617-726-9394
- Email: ssmith133@mgh.harvard.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ages 6 to 18 years old at Randomization
- BMI between the 10th-85th percentiles
- Expert clinical diagnosis of ASD confirmed using the Diagnostic and Statistical Manual of Mental Disorders (DSM) -5 Checklist and a Social Communication Questionnaire (SCQ)-Lifetime
- Availability of parent/guardian to provide informed consent
- If cognitively able, the subject must be able to provide informed assent/consent
Exclusion Criteria:
- Fragile X, tuberous sclerosis, and other single gene defects that are syndromic
- Other conditions that may contribute to low bone density (e.g., hyperprolactinemia, hypogonadism)
- Medications that may impact bone such as specific anti-seizure medications, oral glucocorticoids, combined hormonal contraception
- Hyponatremia
- Creatinine or liver enzymes more than twice the upper limit of the normal range
- Changes in doses of antipsychotics that can cause hyperprolactinemia within 2 months of the baseline visit
- Substance use disorder within the last 6 months
- History of known coronary artery disease, heart failure, reduced ejection fraction, hypertrophic cardiomyopathy, ventricular arrhythmias, or prolonged QT
- Active seizures within 6 months preceding the Screening visit or the Baseline visit
- Subjects who are pregnant, lactating, or who refuse contraception if sexually active
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1. Intranasal Oxytocin
Intranasal oxytocin spray (30 IU twice daily) for 12 months in the double-blinded phase followed by intranasal oxytocin spray (30 IU twice daily) for 6-months in the open-label phase
|
30 IU, twice daily for 12 months in the experimental arm in double-blinded phase
30 IU, twice daily for 6 months in both experimental and placebo comparator arm in open-label phase
|
Placebo Comparator: 2. Placebo
Intranasal placebo spray (30 IU twice daily (total 60 IU per day) for 12 months followed by intranasal oxytocin spray (30 IU twice daily) for 6-months in the open-label phase
|
30 IU, twice daily for 6 months in both experimental and placebo comparator arm in open-label phase
30 IU, twice daily for 12 months in the placebo comparator arm in double-blinded phase
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The 12-month change in the whole body less head areal BMD Z-score between IN OXT vs. placebo
Time Frame: 12 months
|
A whole body less head areal BMD Z-score between -2 to +2 indicates normal bone mineral density
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The 12-month change in femoral neck areal BMD Z-score between IN OXT vs. placebo
Time Frame: 12 months
|
A femoral neck areal BMD Z-score between -2 to +2 indicates normal bone mineral density
|
12 months
|
The 12-month change in the radial cortical area between IN OXT vs. placebo
Time Frame: 12 months
|
High-resolution peripheral quantitative computed topography (HR-pQCT) will be used to assess the radial cortical area at the non-dominant wrist (if fracture history, then non-fractured side will be used).
Using a scout, the reference line will be set at the bone endplate.
Scans will be acquired at a distance from the endplate relative to the individual's limb length (ultradistal sites: 7%; diaphyseal sites: 30%) to adjust for body size.
Each scan includes 168 slices with an isotropic voxel size of 61 µm3.
|
12 months
|
The 12-month change in tibial cortical area between IN OXT vs. placebo
Time Frame: 12 months
|
High-resolution peripheral quantitative computed topography (HR-pQCT) will be used to assess the tibial cortical area at the non-dominant leg (if fracture history, then non-fractured side will be used).
Using a scout, the reference line will be set at the bone endplate.
Scans will be acquired at a distance from the endplate relative to the individual's limb length (ultradistal sites: 7%; diaphyseal sites: 30%) to adjust for body size.
Each scan includes 168 slices with an isotropic voxel size of 61 µm3.
|
12 months
|
The 12-month change in radial trabecular thickness between IN OXT vs. placebo
Time Frame: 12 months
|
High-resolution peripheral quantitative computed topography (HR-pQCT) will be used to assess the radial trabecular thickness at the non-dominant wrist (if fracture history, then non-fractured side will be used).
Using a scout, the reference line will be set at the bone endplate.
Scans will be acquired at a distance from the endplate relative to the individual's limb length (ultradistal sites: 7%; diaphyseal sites: 30%) to adjust for body size.
Each scan includes 168 slices with an isotropic voxel size of 61 µm3.
The trabecular thickness will be calculated using the direct 3D distance transformation method.
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023P000307
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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