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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02413190
Registration number
NCT02413190
Ethics application status
Date submitted
6/04/2015
Date registered
9/04/2015
Titles & IDs
Public title
Bone Health in Facioscapulohumeral Muscular Dystrophy
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Scientific title
Bone Health in Facioscapulohumeral Muscular Dystrophy: A Cross-sectional Study
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Secondary ID [1]
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IRB00031738
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Universal Trial Number (UTN)
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Trial acronym
FSHD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Facioscapulohumeral Muscular Dystrophy
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Neurological
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Other neurological disorders
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Human Genetics and Inherited Disorders
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Bone Mineral Density in FSHD
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Assessment method [1]
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To determine if bone mineral density is reduced in individuals with FSHD compared to normative data of individuals of the same age and gender without FSHD.The Bone Mineral Density Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population
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Timepoint [1]
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Single visit
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Eligibility
Key inclusion criteria
* Genetic diagnosis of FSHD including chromosome 4 deletion and haplotype
* Age > 18 years
* Ability to provide written informed consent for participation in the study
* Ability to participate in the DEXA scan
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Minimum age
18
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Unwillingness or inability to comply with the requirements of this protocol (in the opinion of the PI) including, but not limited to, the presence of any condition (physical, mental or social) that precludes the participant from comfortably and safely obtaining a DEXA scan, phlebotomy, or neurological examination
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2016
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Sample size
Target
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Accrual to date
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Final
94
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Concord Hospital Neurology Department, Hospital Road, Concord NSW 2139 - Sydney
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Maryland
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Funding & Sponsors
Primary sponsor type
Other
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Name
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Concord Hospital
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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FSHD Global Research Foundation
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a cross-sectional single visit study to determine bone health in individuals with FSHD.
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Trial website
https://clinicaltrials.gov/study/NCT02413190
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02413190