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Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Markers of Osteoporosis in Cystic Fibrosis

Clinicaltrials.gov identifier NCT03921060

Recruitment Status Not yet recruiting

First Posted April 19, 2019

Last update posted March 16, 2020

Study Description

Brief summary:

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:Cystic Fibrosis
  • Intervention/Treatment: Drug: Denosumab
  • Phase: Phase 4
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 100 participants
  • Allocation: Non-Randomized
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Diagnostic
  • 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
Arms and interventions
Arm Intervention/treatment
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.
Drug: Denosumab
treatment with denosumab every 6 months for up to 5 years
Outcome Measures
  • Primary Outcome Measures: 1. 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
  • 2. 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.
Eligibility Criteria
  • Ages Eligible for Study: 12 to 64 Years (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
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

Contacts and Locations
Contacts

Contact: Ashley Keller 2146482817 ashley.keller@utsouthwestern.edu

Locations

United States, Texas
UT Southwestern Medical Center
Dallas

Sponsors and Collaborators

University of Texas Southwestern Medical Center

More Information
  • Responsible Party: University of Texas Southwestern Medical Center
  • ClinicalTrials.gov Identifier: NCT03921060 History of Changes
  • Other Study ID Numbers: STU 052018-007
  • First Posted: April 19, 2019 Key Record Dates
  • Last Update Posted: March 16, 2020
  • Last Verified: March 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Osteoporosis
    Cystic Fibrosis
    Fibrosis