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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Markers of Osteoporosis in Cystic Fibrosis
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- 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.