Markers of Osteoporosis in Cystic Fibrosis

This study is looking at bone health in people with Cystic Fibrosis (CF). Researchers want to understand how osteoporosis (weak bones) develops in CF patients. The study involves a main part where up to 100 people, including CF patients and healthy volunteers, will have a single visit for bone scans (DEXA and micro CT) and blood tests. A smaller group of about 10 adult CF patients with bone disease from the main study may then receive a medication called Denosumab (Prolia) every six months for up to five years. The main goal is to see how bone density changes over time, measured by DEXA and micro CT scans. You may be able to join if you are between 18 and 64 years old and have a confirmed CF diagnosis. The study status is currently unclear.

Study design
This is an interventional study with up to 100 participants. It includes a main study and a sub-study where some participants will receive Denosumab.
What's involved
If you join the main study, you will have a single visit for a DEXA scan, micro CT scan, and blood collection. If you are in the sub-study, you will receive Denosumab every 6 months for up to 5 years and return annually for repeat scans, blood tests, and to report any side effects.
Compensation
Not stated in the trial record.
Follow-up
Participants in the sub-study will be followed for up to 5 years, with DEXA and micro CT results measured at single timepoints and for changes over this period.

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NCT03921060

Markers of Osteoporosis in Cystic Fibrosis

Recruiting
PHASE4Ages 18–64InterventionalDiagnostic
University of Texas Southwestern Medical Center
~100 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:Denosumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
DEXA results
Measured over Looking at single timepoints and well as changes for up to 5 years for those in the sub-study
+1 more outcome measured
Cystic Fibrosis
1 sites across 1 states
Texas1

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Eligibility criteria

Inclusion

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

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
  • DEXA resultsLooking at single timepoints and well as changes for up to 5 years for those in the sub-study

    Z and/or T scores

  • Micro CT resultsLooking at single timepoints and well as changes for up to 5 years for those in the sub-study

    Trabecular bone volume to tissue volume (BV/TV), cortical and trabecular thickness (Tb.Th, microns), trabecular spacing (Tb.Sp; microns), and structure model index (SMI; index of trabecular rod vs plate-like shape/ stoutness) will be assessed. Change in BV/TV and cortical thickness will be taken to indicate increased/decreased bone mass accrual by microCT.