drugset / Trial / NCT02299817
Denosumab for Treating Periprosthetic Osteolysis.
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
Publications
- Axenhus M, Boden H, Kelly-Pettersson P, Skoldenberg O. Denosumab for treating periprosthetic osteolysis: a feasibility study. BMC Res Notes. 2025 Apr 8;18(1):151. doi: 10.1186/s13104-025-07216-0.
- Skoldenberg O, Rysinska A, Eisler T, Salemyr M, Boden H, Muren O. Denosumab for treating periprosthetic osteolysis; study protocol for a randomized, double-blind, placebo-controlled trial. BMC Musculoskelet Disord. 2016 Apr 23;17:174. doi: 10.1186/s12891-016-1036-5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Denosumab | Monoclonal antibody | 60 mg | Subcutaneous |