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Denosumab for Fibrous Dysplasia
Study Summary
This trial is testing a medication given every 4 weeks to children with fibrous dysplasia, to see if it stops the growth of FD bone lesions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 4 trial • 76 Patients • NCT02176382Trial Design
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Who is running the clinical trial?
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- My calcium levels are currently low, but I can try to increase them.I have not had any bone surgery in the 6 weeks before starting denosumab.I am between 4 and 14 years old.I have been diagnosed with fibrous dysplasia.I have had, or currently have, a bone infection or bone death in my jaw.I have had a bone fracture within the last 6 weeks.My guardian or I can understand and are willing to sign the consent form.I have a dental or oral surgery wound that hasn't healed.I plan to undergo a dental surgery during the study.
- Group 1: treatment
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are recruitment efforts for this clinical trial ongoing?
"That is accurate, the clinicaltrials.gov website has information indicating that this trial is still recruiting patients. The listing for the study says that it was first posted on October 12th, 2020 and updated October 15th, 2020. They are looking for a total of 15 participants across 1 location."
How many people total are participating in this experiment?
"Yes, the information on clinicaltrials.gov says that this trial is actively seeking patients. The clinical trial was first posted on 10/12/2022 and was most recently updated on 10/15/2022. The trial is searching for 15 patients at 1 locations."
Does this research project allow for young adults to participate?
"Children aged 4-14 years old are currently being enrolled in this trial."
What is the government's stance on denosumab?
"Denosumab's safety is still being explored in clinical trials, but early data suggests it is safe. It received a score of 2."
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