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Bone Mass Accrual in Children With Autism Spectrum Disorder

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ClinicalTrials.gov Identifier: NCT03162445
Recruitment Status : Completed
First Posted : May 22, 2017
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):
Ann Neumeyer, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease
Autism Spectrum Disorder Bone Diseases, Developmental

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 49 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Bone Mass Accrual in Children With Autism Spectrum Disorder
Actual Study Start Date : January 11, 2010
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Typically developing controls
Boys between ages 7 and 14 years old at study onset without medications or diseases impairing bone development
Autism spectrum disorder
Boys between ages 7 and 14 years old at study onset without medications or diseases impairing bone development



Primary Outcome Measures :
  1. Bone Mineral Density [ Time Frame: Bone mineral density will be assessed within one month of enrolling in the study. ]
    using dual energy x-ray absorptiometry (DXA) (Hologic Discovery A, Software Version: APEX 4.0.2, Bedford, MA USA) at the total hip, femoral neck, lumbar spine (L1-4), whole body and whole body less head bone mineral density.



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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adolescent boys, ages 8-17 years, recruited from a clinic population (ASD) or community advertisements (ASD and control) matched for age.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03162445


Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Ann M Neumeyer, MD Massachusetts General Hospital
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Responsible Party: Ann Neumeyer, Assistant Professor Neurology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03162445    
Other Study ID Numbers: 2009P002422
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: May 22, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ann Neumeyer, Massachusetts General Hospital:
bone mineral density
Autism Spectrum Disorder
Autism
Additional relevant MeSH terms:
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Bone Diseases
Bone Diseases, Developmental
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Musculoskeletal Diseases