What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Denosumab, a RANKL inhibitor, is commonly used to treat conditions like osteoporosis and bone metastases. Known side effects include hypocalcemia, increased risk of infections, dermatologic reactions, and osteonecrosis of the jaw. Additionally, discontinuation of Denosumab can lead to rebound vertebral fractures. Bisphosphonates, another class of drugs used for similar conditions, share some side effects such as gastrointestinal issues, acute phase reactions, and also osteonecrosis of the jaw. Both treatments require careful monitoring to manage these potential adverse effects.

What prior FDA approvals exist?

Denosumab, a RANKL inhibitor, has been approved by the FDA for the treatment of various bone-related conditions, including osteoporosis and bone metastases. Similar treatments include bisphosphonates such as zoledronic acid and pamidronate, which are used to manage bone metastases in cancers and multiple myeloma-related bone disease by inhibiting osteoclast-mediated bone resorption. These drugs help reduce skeletal-related events and improve bone density.

What other types of research exist?

Promising novel alternatives to Denosumab for osteopathy patients in 2024 include Romosozumab, a sclerostin inhibitor, and parathyroid hormone analogs such as abaloparatide. These treatments offer different mechanisms of action and have shown efficacy in increasing bone density and reducing fracture risk.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 3 months

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

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

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

2013

Completed Phase 4

~12010

0 / 7Eligibility criteria met

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.