Markers of Osteoporosis in Cystic Fibrosis

  • STATUS
    Recruiting
  • End date
    Jul 1, 2027
  • participants needed
    100
  • sponsor
    University of Texas Southwestern Medical Center
Updated on 1 May 2022
fibrosis
sweat test
Accepts healthy volunteers

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.

Details
Condition Cystic Fibrosis
Treatment Denosumab
Clinical Study IdentifierNCT03921060
SponsorUniversity of Texas Southwestern Medical Center
Last Modified on1 May 2022

Eligibility

Yes No Not Sure

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

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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