National Institutes of Health Clinical Center, Bethesda, MD
Disease Progression+2 More
denosumab - Drug
You have a chance of qualifying for this trial. We made sure your application will take less than 5 minutes.
What conditions do you have?
What conditions do you have?
Fibrous dysplasia (FD) is a disease that affects the bones. It causes bone lesions that can become weak and lead to fractures, deformity, and nerve injuries. FD bone lesions begin to develop soon after birth and grow during childhood. The lesions stop growing in adults but can still cause disability. Researchers want to find ways to stop the growth of FD bone lesions.
To test a study drug (denosumab) in children with FD.
Children aged 4 to 14 years with FD and who are also enrolled in the Screening and Natural History protocol (98-D-0145).
Participants will have a screening visit at the NIH clinic or by telehealth. Their medical history will be reviewed.
Participants will stay overnight in the hospital 4 times in 76 weeks. Each stay will last 5 to 7 nights.
Participants will also visit a local lab for blood and urine tests every 4 weeks during the study.
Participants will receive denosumab once every 4 weeks for 48 weeks. The medication is given as a shot injected under the skin using a small needle. Some injections may be performed at home by a caregiver. The caregiver will receive training for this procedure.
Participants will undergo many tests that may be repeated throughout the study. They will have a dental exam. They will have tests of their strength and ability to move freely. They will have x-rays and other scans to get pictures of their bones.
Participants will be given another medicine that is administered through a needle in the arm over 30 minutes.
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT02176382) in the Standard Dose Teriparatide ARM group. Side effects include: wrist fracture with 5%, breast cancer with 5%, shoulder dislocation with 3%, pancreatitis with 3%, fibula avulsion fracture with 3%.
1 Treatment Group
1 of 1
15 Total Participants · 1 Treatment Group
Primary Treatment: denosumab · No Placebo Group · Phase 2
Experimental Group · 1 Intervention: denosumab · Intervention Types: Drug
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4
Screening: ~3 weeks
Reporting: 76 weeks
Closest Location: National Institutes of Health Clinical Center · Bethesda, MD
2016First Recorded Clinical Trial
3 TrialsResearching Disease Progression
276 CompletedClinical Trials
Who is running the clinical trial?
National Institute of Dental and Craniofacial Research (NIDCR)Lead Sponsor
275 Previous Clinical Trials
804,812 Total Patients Enrolled
1 Trials studying Disease Progression
157 Patients Enrolled for Disease Progression
Alison M Boyce, M.D.Principal InvestigatorNational Institute of Dental and Craniofacial Research (NIDCR)
3 Previous Clinical Trials
524 Total Patients Enrolled
Age < 18 · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:
You have an IUD or IUS in place.
You have a confirmed diagnosis of fibrous dysplasia.
You are enrolled in the companion Screening and Natural History protocol 98-D-0145.
You are willing to comply with all study procedures and available for the duration of the study.
You are able to understand the information provided in the consent form and are willing to sign the form.
Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.