Investigating bone health in cystic fibrosis patients
Markers of Osteoporosis in Cystic Fibrosis
PHASE4 · University of Texas Southwestern Medical Center · NCT03921060
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 | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Drugs / interventions | denosumab |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT03921060 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with cystic fibrosis who are willing to participate in long-term follow-up.
Not a fit: Patients without a cystic fibrosis diagnosis or those without osteoporosis will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Dallas, Texas
- UT Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Ashley Keller
- Email: ashley.keller@utsouthwestern.edu
- Phone: 2146482817
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cystic Fibrosis