Investigating bone health in cystic fibrosis patients
Official title: Markers of Osteoporosis in Cystic Fibrosis
Run by University of Texas Southwestern Medical Center · NCT03921060 · Data updated 2026-11-12
This study is testing how bone health is affected in people with cystic fibrosis and whether a medication called denosumab can help improve it.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | denosumab |
| Locations | 1 site (Dallas, Texas) |
| Status | Recruiting |
| Started | September 2, 2021 |
| Main results expected | July 2027 |
| Study ends | July 2027 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT03921060 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults diagnosed with cystic fibrosis who are willing to participate in long-term follow-up.
✕Probably not a fit
Patients without a cystic fibrosis diagnosis or those without osteoporosis will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study involves up to 100 participants, including both cystic fibrosis (CF) patients and non-CF volunteers, who will undergo a single visit for assessments including DEXA scans, micro CT imaging, and blood collection to evaluate bone health. Additionally, a sub-study will treat approximately 10 adult CF patients with denosumab, a medication for osteoporosis, for up to 5 years, with annual follow-up visits for repeat assessments. The goal is to understand the markers of osteoporosis in CF and the effects of denosumab on bone health.
Why it matters
Potential benefit: If successful, this study could improve the management of bone health in cystic fibrosis patients, potentially reducing the risk of fractures and osteoporosis.
How similar studies have gone: While there is ongoing research into osteoporosis in cystic fibrosis, the specific use of denosumab in this context is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
UT Southwestern Medical Center
Dallas, Texas, United States Recruiting
Study contacts
- Study coordinator: Ashley Keller
- Email: ashley.keller@utsouthwestern.edu
- Phone: 2146482817
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.