Title: 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 Phase: 3 Indication: Glucocorticoid-induced Osteoporosis~Primary Objective: To evaluate the effect of denosumab on lumbar spine bone mineral density (BMD) Z-score as assessed by dual-energy X-ray absorptiometry (DXA) at 12 months in children 5 to 17 years of age with Glucocorticoid (GC)-induced osteoporosis (GiOP).~Secondary Objective(s): To evaluate the effect of denosumab in children 5 to 17 years of age with GiOP with respect to:~Change in lumbar spine BMD Z-score as assessed by DXA from baseline to 6, 18, 24, and 36 months~Change in proximal femur BMD Z-score as assessed by DXA from baseline to 6, 12, 18, 24, and 36 months~Number of participants with X-ray confirmed long-bone fractures and new and worsening vertebral fractures from pre-treatment to posttreatment at 12, 24, and 36 months~Number of participants with improving vertebral fractures from pre-treatment to posttreatment at 12, 24, and 36 months (overall, among subjects with clinical fracture reduction, and among subjects with clinical fracture increase)~Number of participants with pre-treatment, post-treatment, and post-withdrawal vertebral and nonvertebral fractures at 12, 24, and 36 months~Change in Childhood Health Questionnaire - Parent Form-50 (CHQ-PF-50) Physical Summary Score at 12, 24, and 36 months~Change in CHQ-PF-50 Psychological Summary Score at 12, 24, and 36 months~Change in Childhood Health Assessment Questionnaire (CHAQ) Disability Index Score at 12, 24, and 36 months~Change in Wong-Baker Faces Pain Rating Scale (WBFPRS) at 12, 24, and 36 months~Change in growth velocity, determined by calculating age-adjusted Z-scores for height, weight, and body mass index (BMI), at 24 and 36 months~Serum concentration of denosumab at 1 and 10 days, and 6, 12, and 18 months (additional serum denosumab pharmacokinetics [PK] samples to be collected at day 30 and month 3 in a PK/bone turnover marker [BTM] substudy of up to 15 subjects) Hypotheses: The hypothesis of this study is that the change from baseline in lumbar spine BMD Z-score following 12 months of denosumab treatment in children 5 to 17 years of age with GiOP will be greater than placebo.
To evaluate the effect of denosumab on lumbar spine bone mineral density (BMD) Z-score as assessed by dual-energy X-ray absorptiometry (DXA) at 12 months in children 5 to 17 year of age with Glucocorticoid (GC)-induced osteoporosis (GiOP).