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Denosumab for Fibrous Dysplasia
Study Summary
This trial is a single-center, open-label study of the effects of denosumab on bone turnover in people with fibrous dysplasia.
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 2022 Phase 4 trial • 37 Patients • NCT04026256Trial Design
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- 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.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.My vitamin D level is below 30 ng/mL.My low phosphorus levels have not been treated properly.I have been diagnosed with Fibrous Dysplasia.I understand the study and can give my consent.I have a dental or oral surgery wound that hasn't healed.I am willing to take calcium and vitamin D supplements.I haven't taken bisphosphonates in the last year.I had bone surgery less than 12 weeks ago.I am willing and able to follow the study's schedule and take the medications as directed.I plan to have a dental surgery during the study.
- Group 1: 1
- 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
Is there a possibility for new participants to join this experimental research?
"Unfortunately, this research study is no longer actively searching for participants. It was initially posted in June 2019 and most recently updated on February 2022. There are currently 361 trials recruiting patients with bone diseases and 48 studies utilising Denosumab that remain open to enrolment."
To what extent is Denosumab a safe treatment option for individuals?
"The safety of Denosumab was judged to be a 2 on the scale from 1-3 due to Phase 2 trial results which suggest some security, yet no evidence for efficacy."
In what clinical situations is Denosumab usually prescribed?
"Denosumab is efficacious in treating bone-related conditions such as skeletally mature individuals and those with an imbalance of androgens."
How many participants are taking part in this clinical probe?
"At present, this medical trial is not in the process of recruiting participants. The study was launched on June 13th 2019 and underwent its last edit on February 17th 2022. For those looking for studies related to bone diseases or Denosumab, 361 and 48 clinical trials are actively enrolling patients respectively."
Are there any other scientific investigations that have been carried out concerning Denosumab?
"Presently, there are 48 live trials researching Denosumab; 12 of these studies being at the Phase 3 stage. While most investigations into Denosumab take place in Nedlands, Western Australia, a total of 488 trial sites exist for this medication."
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