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Denosumab for Pediatric Osteoporosis
Study Summary
This trial looks at the effects of denosumab on the spine of children with Glucocorticoid-induced osteoporosis.
- Glucocorticoid-induced Osteoporosis
- Denosumab Safety and Efficacy in Pediatric Subjects
Timeline
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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Who is running the clinical trial?
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- You have overactive thyroid, unless it's being well managed with medication.You have Duchenne muscular dystrophy and have heart problems that are causing symptoms.You have been diagnosed with osteoporosis by a specialized medical society.You have had cancer in the past.You have osteoporosis from causes other than using corticosteroids, or you have had fractures due to medications other than corticosteroids.You currently have trouble absorbing nutrients from food.You are currently taking steroids only for adrenal insufficiency.You have had a history of hyperparathyroidism.You have a certain type of spinal fracture or a history of significant fractures with low bone density in your lower back.You have underactive thyroid, unless it is well managed with consistent medication.You have hypoparathyroidism right now.You have a current infection or a history of infections.You can't tolerate calcium or vitamin D supplements.You have a non-cancerous condition that needs to be treated with steroid medication.You have had a serious infection or needed strong antibiotics in the past few weeks, or have a long-lasting or recurring infection that could affect your safety in the study.
- Group 1: Denosumab
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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 patients of all ages being accepted for this trial?
"Eligible patients for this clinical trial must be younger than 17 years old and older than 5 years."
Are there previous examples of successful treatments using Denosumab?
"Denosumab's original clinical trial took place in 2014 at the Hirslanden Klinik Aarau. As of now, there have been a total of 18329 completed trials. There are currently 49 ongoing studies, a significant portion of which are located in Montreal, Quebec."
For what purpose is Denosumab most often prescribed?
"Denosumab is a medication used to manage bone and bone-related conditions. It is effective for treating skeletally mature patients, and can also help with androgen and malignant neoplasm management."
From how many different sites are researchers collecting data for this investigation?
"This clinical trial has 15 sites that are currently enrolling patients. A few notable locations include Sainte Justine in Montreal, Childrens Hospital of Los Angeles, and Childrens Hospital of Eastern Ontario in Minneapolis."
Who meets the inclusion criteria for this experiment?
"Researchers are looking for 24 individuals aged 5-17 who have been prescribed denosumab. Key requirements for applicants include: having at least 1 Genant Grade 1 vertebral compression fracture (as assessed by central imaging vendor), OR in the absence of vertebral compression fractures, presence of both clinically significant fracture history and lumbar spine BMD Z-score ≤ -2.0 (as assessed by central imaging vendor); Subjects who are on systemic GC only as replacement therapy for adrenal insufficiency are not eligible for the study; A confirmed diagnosis of non-malignant condition(s) requiring treatment with systemic GC; Treatment with"
Has the Food and Drug Administration cleared Denosumab for public use?
"There is some data supporting the efficacy of denosumab, and it has been through multiple rounds of testing, so we believe it to be safe and give it a rating of 3."
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