Clinical trial · Interventional
The Role of Bisphosphonate and Simvastatin Combination on Therapeutic Response in Breast Cancer With Bone Metastasis Via Dicckopf-1 Pathway
The Role of Bisphosphonate and Simvastatin Combination on Therapeutic Response in Breast Cancer With Bone Metastasis Via Dicckopf-1 Pathway : A Randomised, Double-blind, Placebo Controlled Pilot Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer With Bone Metastasis | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Simvastatin | Drug | — | UNRESOLVED |
| Zoledronic Acid (Zometa) | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ZA + Simvastatin
- description
- Participants received zoledronic acid combined with simvastatin 40 mg daily for six treatment cycles. Each cycle was separated by three weeks, and simvastatin was administered at night.
- interventionNames
- Drug: Simvastatin
- Drug: Zoledronic Acid (Zometa)
- type
- PLACEBO_COMPARATOR
- label
- ZA + Placebo
- description
- Participants received zoledronic acid combined with placebo for six treatment cycles. Each cycle was separated by three weeks, and placebo was administered daily at night
- interventionNames
- Drug: Placebo
- Drug: Zoledronic Acid (Zometa)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Women diagnosed with breast cancer with confirmed bone metastasis based on bone scan. * Previously received systemic chemotherapy. * Scheduled to initiate bisphosphonate therapy as part of standard oncologic management. * Age \>18 years. * ECOG performance status ≤1. * Written informed consent. * Serum creatinine ≤1.5 times normal range. * ALT ≤2 times normal range or total bilirubin ≤1.5 times normal range. Exclusion Criteria: * Pregnancy or lactation. * Prior or ongoing simvastatin or other statin treatment. * Known hypersensitivity to bisphosphonates. * Allergy to statins.
References
Publications (0)
Data not yet available