drugset / Trial / NCT03921060

Markers of Osteoporosis in Cystic Fibrosis

NCT03921060

Phase 4 Recruiting 100 enrolled University of Texas Southwestern Medical Center
Non-randomizedSequentialTriple-blindDiagnostic

Summary

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.

Timeline

Start
2021-09-02
Primary completion
2027-07
Completion
2027-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Denosumab Monoclonal antibody 60 mg/ml Subcutaneous

Indications