Markers of Osteoporosis in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Markers of Osteoporosis in Cystic Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03921060
• Other study ID #: STU 052018-007
• Status: Recruiting
• Phase: Phase 4
• Start date: September 2, 2021
• Est. completion date: July 2027

Study information

• Verified date: April 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Ashley Keller
• Phone: 2146482817
• Email: ashley.keller[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Osteoporosis

Intervention

Drug:
• Denosumab
treatment with denosumab every 6 months for up to 5 years

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DEXA results	Z and/or T scores	Looking at single timepoints and well as changes for up to 5 years for those in the sub-study
Primary	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.	Looking at single timepoints and well as changes for up to 5 years for those in the sub-study