Effects of oxytocin on bone health in children with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.