Jun 2016 – Aug 2017
The AIR-P will provide support to conduct the specific Bone Mineral Density (BMD) assessments as part of the larger trial designed to investigate the effects of intranasal oxytocin, a bone anabolic hormone, on BMD and structure in children with autism spectrum disorder (ASD).
The SOARS-B trial (Study of Oxytocin in ASD to improve Reciprocal Social Behaviors) is a pivotal randomized, placebo-controlled investigation of intranasal oxytocin in the treatment of social dysfunction in children and adolescents with ASD that is funded by the NIH. This multi-site clinical trial will assess whether intranasal oxytocin administration in children with ASD results in improvement of reciprocal social behaviors, social motivation, cognitive skills and functioning. Simultaneously, the SOARS-B study provides a unique opportunity to address key knowledge gaps with respect to skeletal health in children with ASD, and to assess the impact of a highly innovative therapy, namely oxytocin, on bone. Oxytocin has been demonstrated to increase bone formation in animal studies, and we have shown in adolescents with bone loss due to hypothalamic amenorrhea that oxytocin levels predict bone density and structure. Impaired bone health and hip fracture have important implications for medical and surgical morbidity in ASD, and the SOARS-B trial provides a unique opportunity to assess whether use of oxytocin in children with ASD has beneficial effects on bone (in addition to social functioning).