RecruitingPhase 4NCT03921060

Markers of Osteoporosis in Cystic Fibrosis


Sponsor

University of Texas Southwestern Medical Center

Enrollment

100 participants

Start Date

Sep 2, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Inclusion Criteria2

  • 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

Exclusion Criteria5

  • 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

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Interventions

DRUGDenosumab

treatment with denosumab every 6 months for up to 5 years


Locations(1)

UT Southwestern Medical Center

Dallas, Texas, United States

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NCT03921060


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