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Markers of Osteoporosis in Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03921060
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : April 25, 2023
Sponsor:
Information provided by (Responsible Party):
Raksha Jain, University of Texas Southwestern Medical Center

Study Description
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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 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 annually for repeat DEXA scans, micro CT, and blood collection.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Denosumab Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Markers of Osteoporosis in Cystic Fibrosis
Actual Study Start Date : September 2, 2021
Estimated Primary Completion Date : July 2027
Estimated Study Completion Date : July 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Denosumab

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Denosumab
treatment with denosumab every 6 months for up to 5 years


Outcome Measures
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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
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Ages Eligible for Study:   18 Years to 64 Years   (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
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Information from the National Library of Medicine

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


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

Locations
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United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Ashley Keller, MPH    214-648-2817    ashley.keller@utsouthwestern.edu   
Principal Investigator: Raksha Jain, MD, MSCI         
Sub-Investigator: Dwight Towler, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
More Information
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Responsible Party: Raksha Jain, Associate Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03921060    
Other Study ID Numbers: STU 052018-007
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 25, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: No
Additional relevant MeSH terms:
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Osteoporosis
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
 Infant, Newborn, Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs