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Bone Health in Facioscapulohumeral Muscular Dystrophy (FSHD)

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ClinicalTrials.gov Identifier: NCT02413190
Recruitment Status : Unknown
Verified May 2016 by Hugo W. Moser Research Institute at Kennedy Krieger, Inc..
Recruitment status was:  Active, not recruiting
First Posted : April 9, 2015
Last Update Posted : May 19, 2016
Sponsor:
Collaborators:
Concord Hospital
FSHD Global Research Foundation
Information provided by (Responsible Party):
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Tracking Information
First Submitted Date April 6, 2015
First Posted Date April 9, 2015
Last Update Posted Date May 19, 2016
Study Start Date July 2014
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 14, 2015)
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 Measures
 (submitted: April 6, 2015)
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.
Change History Complete list of historical versions of study NCT02413190 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 6, 2015)
  • 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 Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bone Health in Facioscapulohumeral Muscular Dystrophy
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 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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The population consists of individuals with Facioscapulohumeral Muscular Dystrophy.
Condition Facioscapulohumeral Muscular Dystrophy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: May 18, 2016)
50
Original Estimated Enrollment
 (submitted: April 6, 2015)
100
Estimated Study Completion Date August 2016
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02413190
Other Study ID Numbers IRB00031738
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study Sponsor Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
  • Concord Hospital
  • FSHD Global Research Foundation
Investigators Not Provided
PRS Account Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Verification Date May 2016