Markers of Osteoporosis in Cystic Fibrosis

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT03921060
Phase
PHASE4
Status
Recruiting
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Conditions

  • Cystic Fibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • Denosumab — DRUG
    treatment with denosumab every 6 months for up to 5 years

Study Details

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.

Key Dates

Start date
Sep 2, 2021
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC

Arms

  • 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 10 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.

Primary Outcome Measure

DEXA results [ Time Frame: Looking at single timepoints and well as changes for up to 5 years for those in the sub-study ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75390
Ashley Keller, MPH
[email protected]
214-648-2817
Raksha Jain, MD, MSCI (PRINCIPAL_INVESTIGATOR)
Dwight Towler, MD (SUB_INVESTIGATOR)
Naim Maalouf, MD, PhD (SUB_INVESTIGATOR)

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UT Southwestern Medical Center· Dallas, TX

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