drugset / Trial / NCT02677246

Denosumab for Prevention of Bone Complications After Bone Marrow Transplantation in Children

NCT02677246

Phase 1 Withdrawn St. Justine's Hospital
NaSingle-groupOpen-labelPrevention

Summary

Children treated by bone marrow transplantation (BMT) experience bone toxicity. Those bone damages are caused by both a decrease of bone formation and an increase of bone destruction after BMT.For long term survivors, bone complications are major determinants of impaired quality of life. No standard treatment currently exists to prevent those bone injuries. Denosumab is a treatment which specifically blocks bone destruction for 4 to 6 months in adults. This trial will study whether it is safe to prescribe Denosumab to children after BMT in the aim of preventing bone complications.

Timeline

Start
2016-12
Primary completion
2018-09-04
Completion
2018-09-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Denosumab Monoclonal antibody 0.5 mg/kg Subcutaneous
Subject Denosumab Monoclonal antibody 1 mg/kg Subcutaneous
Subject Denosumab Monoclonal antibody 2 mg/kg Subcutaneous