NCT03921060

Markers of Osteoporosis in Cystic Fibrosis

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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 annually for repeat DEXA scans, micro CT, and blood collection.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Denosumab	treatment with denosumab every 6 months for up to 5 years

Timeline

• Start date: 2021-09-02
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2019-04-19
• Last updated: 2025-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study