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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02413190
Other study ID # IRB00031738
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2014
Est. completion date August 2016

Study information

Verified date February 2019
Source Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a cross-sectional single visit study to determine bone health in individuals with FSHD.


Description:

Bone health will be assessed using 1) a DEXA scan to measure bone mineral density and lean body mass, and 2) blood tests of biomarkers of bone resorption and formation. These procedures will be correlated to measures of muscle strength testing and timed function tests to determine fracture risk in FSHD individuals considering age, gender, muscle strength and FSHD allele size.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date August 2016
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

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

Study Design


Related Conditions & MeSH terms

  • Facioscapulohumeral Muscular Dystrophy
  • Muscular Dystrophies
  • Muscular Dystrophy, Facioscapulohumeral

Locations

Country Name City State
Australia Concord Hospital Neurology Department, Hospital Road, Concord NSW 2139 Sydney
United States Kennedy Krieger Institute, Johns Hopkins School of Medicine Baltimore Maryland

Sponsors (3)

Lead Sponsor Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc. Concord Hospital, FSHD Global Research Foundation

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bone Mineral Density in FSHD 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 Single visit
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