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Trial record 19 of 33 for:    FSHD

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.

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

Condition or disease
Facioscapulohumeral Muscular Dystrophy

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
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Bone Health in Facioscapulohumeral Muscular Dystrophy: A Cross-sectional Study
Study Start Date : July 2014
Actual Primary Completion Date : July 2015
Estimated Study Completion Date : August 2016





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. Correlation with bone health markers [ Time Frame: 1 year ]
    To determine if serum markers of bone health correlate with bone mineral density in FSHD.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population consists of individuals with Facioscapulohumeral Muscular Dystrophy.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02413190


Locations
United States, Maryland
Kennedy Krieger Institute, Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21205
Australia
Concord Hospital Neurology Department, Hospital Road, Concord NSW 2139
Sydney, Australia
Sponsors and Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Concord Hospital
FSHD Global Research Foundation

Responsible Party: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier: NCT02413190     History of Changes
Other Study ID Numbers: IRB00031738
First Posted: April 9, 2015    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Facioscapulohumeral
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn