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Markers of Osteoporosis in Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Denosumab
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cystic Fibrosis

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UT Southwestern Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Main Study

Denosomab Sub-study

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

DEXA results
Z and/or T scores
Micro CT results
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.

Secondary Outcome Measures

Full Information

First Posted
March 26, 2019
Last Updated
April 21, 2023
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03921060
Brief Title
Markers of Osteoporosis in Cystic Fibrosis
Official Title
Markers of Osteoporosis in Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2021 (Actual)
Primary Completion Date
July 2027 (Anticipated)
Study Completion Date
July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Main Study
Arm Type
No Intervention
Arm Description
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.
Arm Title
Denosomab Sub-study
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Denosumab
Intervention Description
treatment with denosumab every 6 months for up to 5 years
Primary Outcome Measure Information:
Title
DEXA results
Description
Z and/or T scores
Time Frame
Looking at single timepoints and well as changes for up to 5 years for those in the sub-study
Title
Micro CT results
Description
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.
Time Frame
Looking at single timepoints and well as changes for up to 5 years for those in the sub-study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Keller
Phone
2146482817
Email
ashley.keller@utsouthwestern.edu
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Keller, MPH
Phone
214-648-2817
Email
ashley.keller@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Raksha Jain, MD, MSCI
First Name & Middle Initial & Last Name & Degree
Dwight Towler, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Markers of Osteoporosis in Cystic Fibrosis

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