Can a common cholesterol pill boost bone metastasis treatment?
NCT ID NCT07823751
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are testing whether adding simvastatin, a widely used cholesterol-lowering drug, to zoledronic acid helps women with breast cancer that has spread to bone. Thirty-five women who have already received chemotherapy receive either simvastatin or a placebo alongside zoledronic acid for six treatment cycles. The trial measures changes in a blood protein called DKK-1, bone scan results, bone turnover markers, and pain scores. As a pilot study, it aims to see whether the combination is worth studying further, not to prove it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- simvastatin, a common cholesterol-lowering statin, added to zoledronic acid, a bone-strengthening bisphosphonate
- What this could lead to
- If the combination changes DKK-1 levels or improves bone scan response, it could point toward a low-cost add-on for breast cancer that has spread to bone.
- What could go wrong
- This is a small pilot trial of 35 women and is not designed to prove the combination works. Any signal in DKK-1 or pain scores may not translate into real clinical benefit, and statins can cause muscle aches or liver changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
35 people
The number who actually took part.
- Started
-
Apr 2021
- Finished
-
Jun 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
19 years and older
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Breast cancer with bone metastasis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Dr. Cipto Mangunkusumo National General Hospital / Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia
Jakarta Pusat, DKI Jakarta, 10430, Indonesia