drugset / Trial / NCT01630941
Effects of Denosumab on Periprosthetic Bone After Total Hip Arthroplasty
RandomizedParallel-groupTriple-blindPrevention
Summary
The primary objective is to study the effect of Denosumab on Bone Mineral Density, Standardised Uptake Value and bone metabolism in patients with total hip arthroplasty. The primary hypothesis is to demonstrate that Denosumab is superior to placebo.
Timeline
- Start
- 2012-08-07
- Primary completion
- 2017-01-16
- Completion
- 2017-03-30
Publications
- Skold C, Hailer NP, Mallmin H. Denosumab and bone loss in uncemented total hip arthroplasty: a secondary 5-year follow-up of a randomized controlled trial. Acta Orthop. 2026 Apr 1;97:217-224. doi: 10.2340/17453674.2026.45695.
- Kultima K, Ashtiani SH, Erngren I, Khoonsari PE, Carlsson H, Herman S, Freyhult E, Mallmin H, Hailer NP. Uncemented hip arthroplasty and denosumab: increased postoperative dipeptide concentrations and identification of potential new bone turnover biomarkers. JBMR Plus. 2025 May 19;9(7):ziaf091. doi: 10.1093/jbmrpl/ziaf091. eCollection 2025 Jul.
- Nystrom A, Kiritopoulos D, Ullmark G, Sorensen J, Petren-Mallmin M, Milbrink J, Hailer NP, Mallmin H. Denosumab Prevents Early Periprosthetic Bone Loss After Uncemented Total Hip Arthroplasty: Results from a Randomized Placebo-Controlled Clinical Trial. J Bone Miner Res. 2020 Feb;35(2):239-247. doi: 10.1002/jbmr.3883. Epub 2019 Nov 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Denosumab | Monoclonal antibody | 60 mg | Subcutaneous |