Autism Spectrum DisorderNCT03162445
Bone Mass Accrual in Children With Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder and Bone Diseases, Developmental, run by Massachusetts General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Bone Diseases, Developmental
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- 11 Jan 2010to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- Men only
- Healthy volunteers accepted
- Child
Study population: Adolescent boys, ages 8-17 years, recruited from a clinic population (ASD) or community advertisements (ASD and control) matched for age.
Who may be able to join
- 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)
Who cannot join
- 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
About this study
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.
Read the 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.
- Keywords
- bone mineral density, Autism Spectrum Disorder, Autism
- Medical subject headings
- Autism Spectrum Disorder, Bone Diseases, Developmental, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density
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.
Measured: Bone mineral density will be assessed within one month of enrolling in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start11 Jan 2010
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Neumeyer, Massachusetts General Hospital
- Investigators
- Ann M Neumeyer, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162445
- Sponsor's protocol ID
- 2009P002422
- Status last verified
- May 2017
- First submitted
- 12 May 2017
- Last updated
- 22 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Mass Accrual in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT03162445
- Acronym / sponsor ID
- 2009P002422
- Keywords
- bone mineral density, Autism Spectrum Disorder, Autism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 11 Jan 2010 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Adolescent boys, ages 8-17 years, recruited from a clinic population (ASD) or community advertisements (ASD and control) matched for age.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann M Neumeyer, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Bone Diseases, Developmental, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mineral Density (time frame: Bone mineral density will be assessed within one month of enrolling in the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2017.