drugset / Trial / NCT07823751
The Role of Bisphosphonate and Simvastatin Combination on Therapeutic Response in Breast Cancer With Bone Metastasis Via Dicckopf-1 Pathway
RandomizedParallel-groupTriple-blindTreatment
Summary
This randomised, double-blind, placebo-controlled pilot trial evaluated the therapeutic response of zoledronic acid combined with simvastatin in women with breast cancer and confirmed bone metastases. Participants were randomized to receive zoledronic acid plus simvastatin 40 mg daily or zoledronic acid plus placebo for six treatment cycles. Clinical response, bone scan response, bone turnover biomarkers, and treatment-related safety and tolerability were evaluated. The study was designed as a pilot trial and was not powered to establish definitive efficacy.
Timeline
- Start
- 2021-04-10
- Primary completion
- 2023-04-10
- Completion
- 2026-06-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Simvastatin | Small molecule | 40 mg | Oral |
| Background | Zoledronic acid | Other / unclassified | 4 mg | Intravenous |