Effects of oxytocin on bone health in children with autism
A Randomized, Double-blind, Placebo-controlled Study of Intranasal Oxytocin for Bone Health in Children With Autism Spectrum Disorder
This study is testing if a nasal spray of oxytocin can help improve bone health in children with autism between the ages of 6 and 18.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT05754073 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled study investigates the impact of intranasal oxytocin on bone health in children aged 6-18 years with autism spectrum disorder (ASD). Participants will be assigned to receive either oxytocin or a placebo for 12 months, followed by a 6-month open-label phase where all will receive oxytocin. The study will assess bone mineral density and overall bone health through various examinations, laboratory tests, and imaging techniques. The goal is to determine if oxytocin can improve bone health in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 18 years with a clinical diagnosis of autism spectrum disorder.
Not a fit: Patients with syndromic conditions affecting bone density or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance bone health and reduce fracture risk in children with autism spectrum disorder.
How similar studies have performed: While the approach of using oxytocin for bone health is novel, previous studies have indicated potential benefits of oxytocin in related areas.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts and 1 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- University of Virginia Medical Center — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Elizabeth A Lawson, MD — Neuroendocrine Unit Massachusetts General Hospital
- Study coordinator: Madhusmita Misra, MD, MPH
- Email: abp6bd@uvahealth.org
- Phone: 434-924-9141
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.