Clinical Trial: Bone Health in Facioscapulohumeral Muscular Dystrophy

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

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

Detailed Summary: 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.
Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Current Primary Outcome: Bone mineral density in FSHD [ Time Frame: 1 year ]

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.


Original Primary Outcome: Bone mineral density and lean body mass in FSHD [ Time Frame: 1 year ]

To determine if bone mineral density and lean body mass are reduced in individuals with FSHD compared to normative data of individuals of the same age and gender without FSHD.


Current Secondary Outcome:

  • Fracture frequency [ Time Frame: 1 year ]
    To determine if individuals with FSHD have more fractures compared to normative data of individuals of the same age and gender without FSHD.
  • Correlation with muscle strength and timed function testing [ Time Frame: 1 year ]
    To determine if bone mineral density and lean body mass or fracture history correlate with leg muscle strength or timed function tests in FSHD
  • Correlation with Allele size [ Time Frame: 1 year ]
    To determine if bone mineral density and lean body mass or fracture history correlate with FSHD allele size.
  • Correlation with bone health markers [ Time Frame: 1 year ]
    To determine if serum markers of bone health correlate with bone mineral density in FSHD.


Original Secondary Outcome: Same as current

Information By: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Dates:
Date Received: April 6, 2015
Date Started: July 2014
Date Completion: August 2016
Last Updated: May 18, 2016
Last Verified: May 2016