Cystic Fibrosis study: Denosumab
Official title Markers of Osteoporosis in Cystic Fibrosis
ClinicalTrials.gov ID: NCT03921060
What this study is testing
What is Denosumab?
An investigational injectable medicine being studied for bone disease in cystic fibrosis patients. It is designed to inhibit a protein that breaks down bone.
Also referred to as Prolia.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at bone density and structure in cystic fibrosis patients and compare them to healthy people. It also will see if a drug called denosumab can help those with bone problems.
- Who it's for
- Adults with cystic fibrosis who have bone disease, and healthy adults for comparison.
- What's involved
- Participants will have a bone scan (DEXA), a detailed bone imaging test (micro‑CT), and blood samples taken. Those who get denosumab will have repeat scans, blood tests, and report any side effects.
- Time commitment
- The main visit is one day. The denosumab group may have follow‑up visits for up to five years, with scans and blood tests at each visit.
- Phase 4: studies an already-approved treatment
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64. Healthy volunteers may be eligible.
You may be able to join if
- Cystic Fibrosis Main Study
- Must have CF diagnosis confirmed by sweat test or genotype analysis
- people (and parents/legal guardians as applicable) must have the ability to read and write in English Sub-study
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.