Markers of Osteoporosis in Cystic Fibrosis
ConditionCystic Fibrosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-64
SponsorUniversity of Texas Southwestern Medical Center
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 for repeat DEXA scans, micro CT, blood collection, and documenting of any adverse events.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Denosumab
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov