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Markers of Osteoporosis in Cystic Fibrosis

StatusRecruiting
PhasePhase 4
Started2021-09-02
View on ClinicalTrials.gov ↗

Amendment history

2026-04-30
2 amendments v12-v13
2 re-verifications since 2025-04-10, no change to tracked fields
2024-04-08
Study Status, Contacts/Locations v11
Study sitescontacts updated at 1 of 1 site
2023-04-21
Study Status v10
Re-verified, no change to tracked fields
2022-04-13
Study Status v9
Start dateestimated 2022-03→confirmed 2021-09-02
2022-03-09
Study Status v8
Start date2022-02→2022-03
Show 7 earlier versions
2021-11-19
Study Status v7
Start date2021-10→2022-02
2021-08-27
Study Status v6
Start date2021-07→2021-10
2021-06-28
Study Status v5
Start date2021-05→2021-07
2021-03-05
Study Status v4
Start date2021-02→2021-05
2021-02-04
Not Yet Recruiting→Recruiting Study Status, Sponsor/Collaborators, Oversight, Study Description, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start date2020-12→2021-02
Study sitesdetails revised at 1 of 1 site
2020-03-13
Study Status v2
Primary completion date2026-07→2027-07
Completion date2026-07→2027-07
Start date2019-12→2020-12
2019-09-23
Study Status v1
Start date2019-07→2019-12
2019-04-16
Original filing
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.
Trial Details
NCT Number NCT03921060
Lead Sponsor University of Texas Southwestern Medical Center
Conditions Cystic Fibrosis
Enrollment 100 participants
Start Date 2021-09-02
Primary Completion 2027-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-05-05