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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

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

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

DEXA results

X-Ray Microtomography

Side effects data

From 2022 Phase 4 trial • 37 Patients • NCT04026256

44%

joint pain

22%

nausea

22%

propagation of fracture at biopsy site

11%

dizziness

11%

rhinorrhea

100%

80%

60%

40%

20%

Study treatment Arm

Denosumab Only

Teriparatide Only

Denosumab and Teriparatide

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

2017

Completed Phase 4

~12500

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,675 Total Patients Enrolled

10 Trials studying Cystic Fibrosis

305 Patients Enrolled for Cystic Fibrosis

Media Library

Denosumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03921060 — Phase 4

Cystic Fibrosis Research Study Groups: Main Study, Denosomab Sub-study

Cystic Fibrosis Clinical Trial 2023: Denosumab Highlights & Side Effects. Trial Name: NCT03921060 — Phase 4

Denosumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03921060 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any possibility for me to partake in this clinical experiment?

"This clinical trial seeks 100 cystic fibrosis patients aged between 18 to 64 years old who have the additional prerequisite of qualifying for the sub-study."

Answered by AI

Are young adults within the age range of 35 and below qualified for this medical research project?

"In line with the requirements of this medical study, only individuals aged between 18 and 64 are eligible to take part."

Answered by AI

How many individuals have enrolled in this clinical experiment?

"Affirmative. The clinicaltrials.gov website attests that this experiment is currently recruiting participants, with the initial posting occurring on September 2nd 2021 and the latest update taking place on April 13th 2022. In total, 100 volunteers are needed for a single trial site."

Answered by AI

To what extent is Denosumab hazardous to individuals?

"Having already received approval from the governing body, Denosumab is rated 3 out of 3 for safety as it has entered Phase 4 trials."

Answered by AI

Have any other scientific research studies been conducted using Denosumab?

"Currently, 47 trials are being conducted on denosumab. 12 of these ongoing studies have reached the third phase. The majority of investigations into this medication arise from Nedlands, Western Australia but there are over 470 other research centres around the world researching its efficacy and safety."

Answered by AI

To what ailments is Denosumab frequently prescribed as a remedy?

"Denosumab is typically prescribed to treat bone-related diseases, and can also be used in various other contexts such as skeletally mature individuals, those needing androgens, and patients with malignant neoplasms."

Answered by AI

Is the recruitment process still open for this experiment?

"Affirmative. According to the clinicaltrials.gov, this trial is actively recruiting participants; it was first posted on September 2nd 2021 and last updated April 13th 2022. The study needs 100 people at a single site to participate in the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Markers of Osteoporosis in Cystic Fibrosis

Raksha Jain 2021. "Markers of Osteoporosis in Cystic Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03921060.

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