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
This trial accepts healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Denosumab
Drugtreatment with denosumab every 6 months for up to 5 years
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Main StudyNo intervention 0 interventions
Group B: Denosomab Sub-studyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
DEXA 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-study2
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-studySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov