Markers of Osteoporosis in Cystic Fibrosis

• Status: Recruiting
• Trial end date: 2027-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Denosumab

Criteria

Cystic Fibrosis Main Study Inclusion Criteria:

• 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

Sub-study Exclusion Criteria:

• 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

• Unwilling and/or medically unable to take denosumab