Safety and Efficacy of Denosumab in Children With Osteogenesis Imperfecta—the First Prospective Comparative Study
Authors' conclusion
Treatment with denosumab or zoledronic acid is beneficial in increasing BMD and improving the spinal morphometry of children with OI. However, denosumab should be used with caution in pediatric patients with OI because of its common and dangerous side effect of rebound hypercalcemia. The appropriate dosage and dosing interval of denosumab need to be further explored in children with OI.
Study context
- Population
- Children or adolescents with osteogenesis imperfecta (OI)
- Participants
- 84 children
- Comparison
- Denosumab vs zoledronic acid
Methodological detailsprospective, comparative
- Prospective
- Comparative
Primary result
As reported in the abstract
BMD change from baseline (lumbar spine, femoral neck, total hip) · 12 months
BMD change from baseline (lumbar spine, femoral neck, total hip) · 12 months Denosumab 29.3%, 27.8%, 30.2% · Zoledronic acid 32.2%, 47.1%, 41.1%
Lumbar spine
Femoral neck
Total hip
- Significant bone mineral density (BMD) increase vs baseline in both groups
- all P < .001 vs baseline
Further findings
Spinal morphometry
- Vertebral height and projection area significantly increased after denosumab and zoledronic acid
Safety
- Rebound hypercalcemia a common and serious side effect of denosumab; share reaching hypercalcemic crisis
- 14.3%
- Rebound hypercalcemia could be alleviated by switching to zoledronic acid
Original publication
Safety and Efficacy of Denosumab in Children With Osteogenesis Imperfecta—the First Prospective Comparative Study. J Clin Endocrinol Metab. Published 10 January 2024. doi:10. 1210/ clinem/ dgad732
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