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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
100
treatment with denosumab every 6 months for up to 5 years
UT Southwestern Medical Center
Dallas, Texas, United States
RECRUITINGDEXA results
Z and/or T scores
Time frame: Looking at single timepoints and well as changes for up to 5 years for those in the sub-study
Micro CT results
Trabecular bone volume to tissue volume (BV/TV), cortical and trabecular thickness (Tb.Th, microns), trabecular spacing (Tb.Sp; microns), and structure model index (SMI; index of trabecular rod vs plate-like shape/ stoutness) will be assessed. Change in BV/TV and cortical thickness will be taken to indicate increased/decreased bone mass accrual by microCT.
Time frame: Looking at single timepoints and well as changes for up to 5 years for those in the sub-study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.