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The Role of Bisphosphonate and Simvastatin Combination on Therapeutic Response in Breast Cancer With Bone Metastasis Via Dicckopf-1 Pathway
Sponsor: Indonesia University
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2021-04-10
Completion Date
2026-06-20
Last Updated
2026-09-16
Healthy Volunteers
No
Conditions
Interventions
Simvastatin
Simvastatin 40 mg was administered orally once daily at night for six treatment cycles, with each cycle separated by three weeks, in combination with zoledronic acid
Placebo
An identical placebo tablet was administered orally once daily at night for six treatment cycles, with each cycle separated by three weeks, in combination with zoledronic acid.
Zoledronic Acid (Zometa)
Zoledronic acid 4 mg was administered as an intravenous infusion over 15 minutes for six treatment cycles, with each cycle separated by three weeks.
Locations (1)
Dr. Cipto Mangunkusumo National General Hospital / Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia
Jakarta Pusat, DKI Jakarta, Indonesia