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Monoclonal Antibodies

Denosumab for Fibrous Dysplasia

Phase 2
Recruiting
Led By Alison M Boyce, M.D.
Research Sponsored by National Institute of Dental and Craniofacial Research (NIDCR)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 4 to 14 years
Confirmed diagnosis of fibrous dysplasia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 76 weeks
Awards & highlights

Study Summary

This trial is testing a medication given every 4 weeks to children with fibrous dysplasia, to see if it stops the growth of FD bone lesions.

Who is the study for?
Children aged 4-14 with Fibrous Dysplasia enrolled in a specific NIH study, weighing at least 12 kg. They must have a guardian who can consent to the trial and agree to use effective contraception if of reproductive age. Exclusions include low calcium levels, untreated hypophosphatemia, recent investigational drug use, safety concerns as per investigator's discretion, pregnancy or lactation, allergy to denosumab, jaw bone issues or recent surgeries.Check my eligibility
What is being tested?
The trial is testing denosumab injections every four weeks for one year in children with FD. The goal is to see if it stops the growth of weak and potentially harmful bone lesions. Participants will undergo various tests including dental exams and scans during their hospital stays and local lab visits.See study design
What are the potential side effects?
Denosumab may cause potential side effects such as low calcium levels in blood (hypocalcemia), skin reactions at the injection site, infections due to weakened immune system response, possible impact on growth plates in bones for children.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 4 and 14 years old.
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I have been diagnosed with fibrous dysplasia.
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My guardian or I can understand and are willing to sign the consent form.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~76 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 76 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Skeletal Burden Score
Secondary outcome measures
Adverse events
Change in 18F-NaF PET/CT sentinel lesion intensity (SUVmax)
Change in 18F-NaF PET/CT total lesion activity from baseline to 48 weeks
+3 more

Side effects data

From 2020 Phase 4 trial • 76 Patients • NCT02176382
5%
wrist fracture
5%
breast cancer
3%
clavicle fracture
3%
fibula avulsion fracture
3%
humeral fracture
3%
kidney cancer
3%
pancreatitis
3%
rib fracture
3%
shoulder dislocation
3%
throat cancer
3%
vertebral fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Dose Teriparatide
High Dose Teriparatide

Trial Design

1Treatment groups
Experimental Treatment
Group I: treatmentExperimental Treatment1 Intervention
treatment arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
denosumab
2014
Completed Phase 4
~4450

Find a Location

Who is running the clinical trial?

National Institute of Dental and Craniofacial Research (NIDCR)Lead Sponsor
298 Previous Clinical Trials
847,293 Total Patients Enrolled
Alison M Boyce, M.D.Principal InvestigatorNational Institute of Dental and Craniofacial Research (NIDCR)
3 Previous Clinical Trials
524 Total Patients Enrolled

Media Library

Denosumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05419050 — Phase 2
Fibrous Dysplasia Research Study Groups: treatment
Fibrous Dysplasia Clinical Trial 2023: Denosumab Highlights & Side Effects. Trial Name: NCT05419050 — Phase 2
Denosumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05419050 — Phase 2

Frequently Asked Questions

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

Are recruitment efforts for this clinical trial ongoing?

"That is accurate, the clinicaltrials.gov website has information indicating that this trial is still recruiting patients. The listing for the study says that it was first posted on October 12th, 2020 and updated October 15th, 2020. They are looking for a total of 15 participants across 1 location."

Answered by AI

How many people total are participating in this experiment?

"Yes, the information on clinicaltrials.gov says that this trial is actively seeking patients. The clinical trial was first posted on 10/12/2022 and was most recently updated on 10/15/2022. The trial is searching for 15 patients at 1 locations."

Answered by AI

Does this research project allow for young adults to participate?

"Children aged 4-14 years old are currently being enrolled in this trial."

Answered by AI

What is the government's stance on denosumab?

"Denosumab's safety is still being explored in clinical trials, but early data suggests it is safe. It received a score of 2."

Answered by AI
~2 spots leftby Jun 2024