NCT03921060PHASE4RecruitingAccepts Healthy Volunteers
Markers of Osteoporosis in Cystic Fibrosis
University of Texas Southwestern Medical Center
Start Date
9/2/2021
Completion Date
7/1/2027
Summary
Main Study Up to 100 subjects, both non-CF volunteers and Cystic Fibrosis (CF) patients, will participate in a single study visit that will include a DEXA scan, micro CT, and blood collection. Denosumab (Prolia) Sub study Approximately 10 adult subjects with CF who participated in the main study and have results indicating bone disease will receive treatment with Denosumab for up to 5 years. They will be asked to return for repeat DEXA scans, micro CT, blood collection, and documenting of any adverse events.
Eligibility Criteria
Age Range: 18 years to 64 years
Cystic Fibrosis Main Study Inclusion Criteria:
* Must have CF diagnosis confirmed by sweat test or genotype analysis
* Subjects (and parents/legal guardians as applicable) must have the ability to read and write in English
Sub-study Exclusion Criteria:
* No CF diagnosis
* Men or women without osteoporosis
* Less than 18 years of age
* Unwilling to return annually for study visits for up to 5 years
* Unwilling and/or medically unable to take denosumab
Interventions
DRUG
Denosumab
Conditions
Cystic Fibrosis
Locations
UT Southwestern Medical Center
Dallas, Texas 75390
United States