A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis
Study on Investigational Medication for Children with Glucocorticoid-Induced Osteoporosis
Brief description of study.
We are doing this research study because we are trying to learn more about a drug called Denosumab in children with glucocorticoid-induced osteoporosis.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Glucocorticoid-induced Osteoporosis
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Age: 5 years - 17 years
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Gender: All
Inclusion Criteria
Clinical diagnosis of GiOP
Other criteria exists-please contact study team
This study investigates the effects of an investigational medication on children who have glucocorticoid-induced osteoporosis (GiOP). Osteoporosis is a condition where bones become weak and brittle, and glucocorticoid-induced means it is caused by certain medications known as glucocorticoids.
Participants in this study will receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study will monitor the effects on bone health.
- Who can participate: Children with a clinical diagnosis of glucocorticoid-induced osteoporosis are eligible to participate. For more detailed criteria, please contact the study team.
- Study details: Participants will be assigned to receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.