Markers of Osteoporosis in Cystic Fibrosis
Cystic Fibrosis
About this trial
This is an interventional diagnostic trial for Cystic Fibrosis
Eligibility Criteria
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
Sites / Locations
- UT Southwestern Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Main Study
Denosomab Sub-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 (if not completed as standard of care within 6 months prior to research visit), micro CT, and blood collection.
Approximately 10 subjects with CF that have completed the main study and have results which indicate bone disease are eligible to participate in the sub study. Subjects who consent will receive treatment with denosumab (60 mg/ml via subcutaneous injection in the upper arm, upper thigh, or abdomen every 6 months) for up to 5 years. These subjects will be asked to return every 6 months for injections and annually (+/- 6 months) for up to 5 years for a DEXA scan, micro CT, and blood collection.