Markers of Osteoporosis in Cystic Fibrosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Denosumab.
- Who it may be relevant to
- Registry conditions: Cystic Fibrosis. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 for repeat DEXA scans, micro CT, blood collection, and documenting of any adverse events.
Interventions
- Drug Denosumab
treatment with denosumab every 6 months for up to 5 years
Primary outcome measures
- DEXA results [Time frame: Looking at single timepoints and well as changes for up to 5 years for those in the sub-study]
- Micro CT results [Time frame: Looking at single timepoints and well as changes for up to 5 years for those in the sub-study]
Eligibility criteria
Cystic Fibrosis Main Study 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
Sub-study 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Triple blind
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- UT Southwestern Medical Center — Dallas
Identifiers
NCT: NCT03921060 · STU 052018-007