Denosumab for Fibrous Dysplasia

Recruiting in Palo Alto (17 mi)

Overseen byAlison M Boyce, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Alison M Boyce, M.D.

Principal Investigator

National Institute of Dental and Craniofacial Research (NIDCR)

Eligibility Criteria

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.

Inclusion Criteria

I have had bone pain for at least 3 months in an area affected by FD.

I am 18 years old or older.

I use two reliable birth control methods if I can have children.

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Exclusion Criteria

I have received denosumab in the last year.

I have had jawbone infections or conditions needing oral surgery.

I have had a bone fracture within the last 3 months.

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Treatment Details

Interventions

Denosumab (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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.

Denosumab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Prolia for:

Osteoporosis in postmenopausal women
Bone loss associated with hormone ablation therapy for prostate cancer
Bone loss associated with hormone ablation therapy for breast cancer

🇺🇸 Approved in United States as Prolia for:

Treatment of postmenopausal women with osteoporosis at high risk for fracture
Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer

🇨🇦 Approved in Canada as Prolia for:

Treatment of osteoporosis in postmenopausal women at high risk for fracture
Treatment to increase bone mass in men with osteoporosis at high risk for fracture

🇯🇵 Approved in Japan as Prolia for: