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Monoclonal Antibodies

Denosumab for Fibrous Dysplasia

Phase 2
Waitlist Available
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
Confirmed diagnosis of Fibrous Dysplasia
Ability to understand and provide informed consent
Must not have
Administration of denosumab within the previous year
History or evidence of osteomyelitis/osteonecrosis of the jaw or active dental condition requiring oral surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing denosumab, a drug that helps strengthen bones, in adults with fibrous dysplasia, a condition where bones grow abnormally. Denosumab works by stopping the cells that break down bone tissue, aiming to reduce bone pain and improve bone strength.

Who is the study for?
Adults over 18 with confirmed fibrous dysplasia and chronic bone pain, who have reached skeletal maturity. They must not have used denosumab or bisphosphonates in the past year, be willing to take supplements, use two forms of contraception if applicable, and cannot be pregnant or planning pregnancy within five months post-study.
What is being tested?
The trial tests Denosumab's effects on bone turnover in fibrous dysplasia patients. It involves monthly doses for six months followed by an eight-month observation period. The study measures changes in bone markers, lesion intensity via PET/CT scans, and FD-related pain levels.
What are the potential side effects?
Denosumab may cause low calcium levels, skin rash or eczema, infections due to weakened immune system response (like sinusitis), potential harm to jaw bones (osteonecrosis), muscle pain or spasms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Fibrous Dysplasia.
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I understand the study and can give my consent.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received denosumab in the last year.
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I have had jawbone infections or conditions needing oral surgery.
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I plan to have a dental surgery during the study.
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I have a dental or oral surgery wound that hasn't healed.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary:1. Assessment of markers of bone turnover: Beta-crosslaps, C-telopeptides (bone resorption marker,Procollagen-1-propeptide (bone formation marker)

Side effects data

From 2022 Phase 4 trial • 37 Patients • NCT04026256
31%
nausea
15%
headache
15%
rhinorrhea
8%
phototoxic dermatitis
8%
dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Teriparatide Only
Denosumab and Teriparatide
Denosumab Only

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
Denosumab will be administered at 120 mg per dose every 4 weeks for six months, with loading doses on days 8 and 15 of month 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Denosumab
2020
Completed Phase 4
~12020

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Denosumab, a RANKL inhibitor, works by binding to the RANKL protein, essential for osteoclast formation and activity, thereby reducing bone resorption and increasing bone density. This is particularly important for osteopathy patients as it helps correct the imbalance between bone formation and resorption. Other treatments like bisphosphonates inhibit osteoclast-mediated bone resorption by binding to bone minerals, while teriparatide, a parathyroid hormone analog, stimulates bone formation. These mechanisms are crucial for selecting therapies that target specific pathways in bone metabolism, improving patient outcomes.

Find a Location

Who is running the clinical trial?

National Institute of Dental and Craniofacial Research (NIDCR)Lead Sponsor
308 Previous Clinical Trials
850,267 Total Patients Enrolled
Alison M Boyce, M.D.Principal InvestigatorNational Institute of Dental and Craniofacial Research (NIDCR)
3 Previous Clinical Trials
527 Total Patients Enrolled

Media Library

Denosumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03571191 — Phase 2
Bone Disease Research Study Groups: 1
Bone Disease Clinical Trial 2023: Denosumab Highlights & Side Effects. Trial Name: NCT03571191 — Phase 2
Denosumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03571191 — Phase 2
~1 spots leftby Dec 2025