drugset / Trial / NCT07823751

The Role of Bisphosphonate and Simvastatin Combination on Therapeutic Response in Breast Cancer With Bone Metastasis Via Dicckopf-1 Pathway

NCT07823751 ↗

Completed 35 enrolled Universitas Indonesia
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

EvaluationDrugModalityDoseRoute
Subject Simvastatin Small molecule 40 mg Oral
Background Zoledronic acid Other / unclassified 4 mg Intravenous

Indications