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NCT Number: NCT03921060

Markers of Osteoporosis in Cystic Fibrosis

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location status: Recruiting

Location contact

Ashley Keller, MPH

CONTACT

[email protected]

214-648-2817

Dwight Towler, MD

SUB_INVESTIGATOR

Naim Maalouf, MD, PhD

SUB_INVESTIGATOR

Raksha Jain, MD, MSCI

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Denosumab

Drug

treatment with denosumab every 6 months for up to 5 years

Primary outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley Keller

CONTACT

[email protected]

2146482817

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Apr 19, 2019
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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