Bone Health in Facioscapulohumeral Muscular Dystrophy

Facioscapulohumeral Muscular Dystrophy Clinical Trial

— FSHD  

Official title:

Bone Health in Facioscapulohumeral Muscular Dystrophy: A Cross-sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413190
• Other study ID #: IRB00031738
• Status: Completed
• 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
• 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

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