Markers of Osteoporosis in Cystic Fibrosis
Recruiting · NCT03921060 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Texas Southwestern Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 64 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- UT Southwestern Medical Center - Dallas, Texas, United States