drugset / Trial / NCT02299817

Denosumab for Treating Periprosthetic Osteolysis.

NCT02299817

Phase 2 Unknown 20 enrolled Olof Skoldenberg Danderyd Hospital · collab
RandomizedParallel-groupDouble-blindPrevention

Summary

The main objective is to study the efficacy of denosumab in reducing wear-induced osteolysis around uncemented acetabular implants used in total hip arthroplasty. Patients included in the study will receive the same dose of 60 mg denosumab or placebo (1 ml solution) for a total of 6 doses with start on day one and every 6 months with last treatment at 30 months. The primary endpoint will be the change in volume of the osteolytic lesion over 3 years measured (measured with 3D-CT in cm³).

Timeline

Start
2015-08
Primary completion
2021-01
Completion
2021-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Denosumab Monoclonal antibody 60 mg Subcutaneous

Indications