Markers of Osteoporosis in Cystic Fibrosis
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|ClinicalTrials.gov Identifier: NCT03921060|
Recruitment Status : Not yet recruiting
First Posted : April 19, 2019
Last Update Posted : March 16, 2020
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 50 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 annually for repeat DEXA scans, micro CT, and blood collection.
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: Denosumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Markers of Osteoporosis in Cystic Fibrosis|
|Estimated Study Start Date :||December 2020|
|Estimated Primary Completion Date :||July 2027|
|Estimated Study Completion Date :||July 2027|
No Intervention: 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 (if not completed as standard of care within 6 months prior to research visit), micro CT, and blood collection.
Experimental: Denosomab Sub-study
Approximately 50 subjects with CF that have completed the main study and have results which indicate bone disease are eligible to participate in the sub study. Subjects who consent will receive treatment with denosumab (60 mg/ml via subcutaneous injection in the upper arm, upper thigh, or abdomen every 6 months) for up to 5 years. These subjects will be asked to return every 6 months for injections and annually (+/- 6 months) for up to 5 years for a DEXA scan, micro CT, and blood collection.
treatment with denosumab every 6 months for up to 5 years
- DEXA results [ Time Frame: Looking 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 results [ Time Frame: Looking 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921060
|Contact: Ashley Kellerfirstname.lastname@example.org|
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|