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Markers of Osteoporosis in Cystic Fibrosis

Who can join

Ages 18 to 64 · All sexes · Healthy volunteers welcome

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

About the study

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.

What is being tested

• Denosumab (drug)

Sponsor: University of Texas Southwestern Medical Center · Participants: 100 · Started: Sep 2, 2021

Contact the study team

• Ashley Keller · Phone: 2146482817

Official record on ClinicalTrials.gov — NCT03921060

Locations in the U.S.

Conditions

• Cystic Fibrosis

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.