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Monoclonal Antibodies

Denosumab for Osteoporosis in Cystic Fibrosis

Phase 4

Recruiting

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have CF diagnosis confirmed by sweat test or genotype analysis

Be between 18 and 65 years old

Must not have

No CF diagnosis

Unwilling to return annually for study visits for up to 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up looking at single timepoints and well as changes for up to 5 years for those in the sub-study

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new way to treat CF patients with bone disease. Up to 100 subjects with CF will participate in a single study visit that will include a DEXA scan, micro CT, and blood collection. If results indicate bone disease, subjects will receive treatment with Denosumab for up to 5 years.

Who is the study for?

This trial is for adults with Cystic Fibrosis (CF) who have been diagnosed with osteoporosis. Participants must be able to understand and write in English, and willing to return for annual study visits over a period of up to five years.

What is being tested?

The trial is testing Denosumab's effectiveness on bone disease in CF patients. It involves an initial study visit with scans and blood tests, followed by selected patients receiving Denosumab treatment annually for up to five years.

What are the potential side effects?

Denosumab may cause low calcium levels in the blood, infections, skin issues like eczema or rashes, pain in muscles or bones, and possibly impact jaw bone health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cystic fibrosis diagnosis was confirmed by a sweat test or genetic test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have cystic fibrosis.

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I am not willing to commit to yearly study visits for 5 years.

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I am under 18 years old.

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I do not have osteoporosis.

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I cannot or do not want to take denosumab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ looking at single timepoints and well as changes for up to 5 years for those in the sub-study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~looking at single timepoints and well as changes for up to 5 years for those in the sub-study

This trial's timeline: 3 weeks for screening, Varies for treatment, and looking at single timepoints and well as changes for up to 5 years for those in the sub-study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

DEXA results

X-Ray Microtomography

Side effects data

From 2022 Phase 4 trial • 37 Patients • NCT04026256

31%

nausea

15%

headache

15%

rhinorrhea

phototoxic dermatitis

dizziness

100%

80%

60%

40%

20%

Study treatment Arm

Teriparatide Only

Denosumab and Teriparatide

Denosumab Only

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Denosomab Sub-studyExperimental Treatment1 Intervention

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.

Group II: Main StudyActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Denosumab

2020

Completed Phase 4

~12020

0 / 6Eligibility criteria met