RECRUITINGPhase 4INTERVENTIONAL
Markers of Osteoporosis in Cystic Fibrosis
About This Trial
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 annually for repeat DEXA scans, micro CT, and blood collection.
Who May Be Eligible (Plain English)
Cystic Fibrosis Main Study Who May Qualify:
- 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 Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Denosumab
treatment with denosumab every 6 months for up to 5 years
Locations (1)
UT Southwestern Medical Center
Dallas, Texas, United States