Denosumab for Fibrous Dysplasia
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.
Will I have to stop taking my current medications?
The trial requires that you have not used bisphosphonates (a type of medication for bone conditions) within one year before starting the study. Other current medications are not specifically mentioned, so it's best to discuss your medications with the study team.
What data supports the effectiveness of the drug Denosumab for treating fibrous dysplasia?
Denosumab has shown promise in reducing pain and the size of bone lesions in patients with fibrous dysplasia, as seen in case reports where patients experienced improvements that were not achieved with previous treatments. Additionally, Denosumab is effective in other bone-related conditions, like osteoporosis, by targeting a protein involved in bone breakdown, which may explain its potential benefits in fibrous dysplasia.12345
Is Denosumab generally safe for use in humans?
Denosumab, also known as Prolia or Xgeva, is a biologic treatment that has been monitored for safety in various conditions, including rheumatoid arthritis. Safety data from registers in Europe and the UK show that biologic treatments can have adverse effects, such as infections and cardiovascular events, which are closely monitored to ensure patient safety.678910
How is the drug denosumab unique for treating fibrous dysplasia?
Denosumab is unique because it is a monoclonal antibody that targets RANKL, a protein involved in bone resorption, which is different from traditional treatments like bisphosphonates. It is administered as a subcutaneous injection, offering an alternative route and mechanism for managing bone-related conditions.511121314
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive denosumab at 120 mg per dose every 4 weeks for six months, with loading doses on days 7 and 14 of month 1
Observation
Participants are followed for an 8-month observation period after treatment
Follow-up
A final visit occurs 21 months after denosumab discontinuation to monitor long-term effects
Treatment Details
Interventions
- Denosumab
Denosumab is already approved in European Union, United States, Canada, Japan for the following indications:
- Osteoporosis in postmenopausal women
- Bone loss associated with hormone ablation therapy for prostate cancer
- Bone loss associated with hormone ablation therapy for breast cancer
- 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
- 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
- Treatment of osteoporosis in postmenopausal women
- Treatment of bone loss associated with hormone ablation therapy for prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Dental and Craniofacial Research (NIDCR)
Lead Sponsor