Bone Mass Accrual in Children With Autism Spectrum Disorder

NCT ID: NCT03162445

Last Updated: 2017-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-11

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a observational study to investigate the degree to which bone mineral density is impaired in boys with autism compared with typically developing controls.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Studies have shown that bone cortical thickness is decreased in children with autism and other developmental disabilities. However it is not known whether bone mineral density (BMD) of these children is lower; neither is it known whether there is any correlation between BMD and the child's diet. The overall goal of this study is to improve the long term health of children and adolescents with autism spectrum disorder; more specifically the investigators aim to develop a pilot study to investigate the degree to which BMD is impaired in boys with autism and to explore specific additional risk factors. In addition, the aim is to investigate the degree to which BMD is impaired in boys with Autism Spectrum Disorder (ASD) and to explore specific contributing risk factors including nutritional analysis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autism Spectrum Disorder Bone Diseases, Developmental

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Typically developing controls

Boys between ages 7 and 14 years old at study onset without medications or diseases impairing bone development

No interventions assigned to this group

Autism spectrum disorder

Boys between ages 7 and 14 years old at study onset without medications or diseases impairing bone development

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Boys 8-17 years chronological age
* BMI between the 3rd and 97th percentiles
* Meets DSM-IV criteria for Autism Spectrum Disorder (ASD group)
* Scores \<15 on the Social Communication Questionnaire (control group)

Exclusion Criteria

* Use of medications directly affecting bone metabolism including estrogen/ progesterone preparations and glucocorticoids except local application of glucocorticoid
* Use of anticonvulsants which affect bone density including diphenylhydantoin, phenobarbital, topiramate carbamazepine and valproic acid and also use of lithium
* Children with diseases known to affect bone mineral density including Crohn's disease, celiac, thyroid and renal
* Children who will not tolerate lying still for 30 seconds
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ann Neumeyer

Assistant Professor Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ann M Neumeyer, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2009P002422

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Bone Mass Accrual in Adolescent Athletes
NCT00827151 WITHDRAWN PHASE3
Effects of Jumping on Growing Bones
NCT00000405 COMPLETED PHASE2