Denosumab Treatment in Adolescents

Primary Recommendation

• The American College of Rheumatology guidelines recommend against denosumab in specific pediatric populations, including children ages 4-17 years with glucocorticoid-induced osteoporosis, who should receive oral bisphosphonates instead of denosumab 4, 5, 6

Evidence Quality and Regulatory Status

• Pediatric data on safety and efficacy of denosumab are extremely limited with a very low grade of evidence 1, 2

Critical Safety Concerns Specific to Adolescents

• The rebound effect of denosumab is associated with a marked increase in vertebral fracture risk in addition to hypercalcemia 1, 3

Contraindications in Adolescents

• The American College of Rheumatology guidelines explicitly recommend against denosumab in organ transplant recipients on multiple immunosuppressive agents due to lack of adequate safety data on infections 4, 6

Management Protocol If Denosumab Must Be Used

• Ensure adequate calcium and vitamin D supplementation during denosumab treatment, with a recommended daily intake of 1,000 mg of calcium and 600 IU of vitamin D 6

Preferred Alternative: Bisphosphonates

• For adolescents requiring bone-targeted therapy, oral bisphosphonates are preferred over denosumab due to moderate-quality evidence of low harms in children and an established safety profile in pediatric populations 6, 1, 2