Trial Outcomes & Findings for Bone Health in Facioscapulohumeral Muscular Dystrophy (NCT NCT02413190)
NCT ID: NCT02413190
Last Updated: 2019-11-05
Results Overview
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
COMPLETED
94 participants
Single visit
2019-11-05
Participant Flow
Participant milestones
| Measure |
FSHD
94 subjects
|
|---|---|
|
Overall Study
STARTED
|
94
|
|
Overall Study
COMPLETED
|
94
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bone Health in Facioscapulohumeral Muscular Dystrophy
Baseline characteristics by cohort
| Measure |
FSHD
n=94 Participants
94 subjects with genetically confirmed FSHD1
|
|---|---|
|
Age, Continuous
|
48.9 years
STANDARD_DEVIATION 51.2 • n=99 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
88 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
48 Participants
n=99 Participants
|
|
Region of Enrollment
Australia
|
46 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Single visitPopulation: Z score: Higher numbers represent higher bone mineral density.
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
Outcome measures
| Measure |
FSHD
n=94 Participants
94 subjects with genetically confirmed FSHD1
|
|---|---|
|
Bone Mineral Density in FSHD
|
-0.4 z-score
Interval -4.0 to 3.0
|
Adverse Events
FSHD
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place