Breast Cancer With Bone MetastasisNCT07823751
The Role of Bisphosphonate and Simvastatin Combination on Therapeutic Response in Breast Cancer With Bone Metastasis Via Dicckopf-1 Pathway
A study testing Simvastatin and Zoledronic Acid (Zometa) in people with Breast Cancer With Bone Metastasis, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Breast Cancer With Bone Metastasis
- What is being tested?
- Simvastatin and Zoledronic Acid (Zometa)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Apr 2021to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy or lactation.
- Prior or ongoing simvastatin or other statin treatment.
- Known hypersensitivity to bisphosphonates.
- Allergy to statins.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Cipto Mangunkusumo National General Hospital / Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia
Jakarta Pusat, DKI Jakarta, 10430
About this study
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
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.
Read the detailed description
This was a prospective, single-center, randomized, double-blind, placebo-controlled pilot trial involving women with breast cancer and confirmed bone metastases. Participants were randomized to receive either zoledronic acid (ZA) in combination with simvastatin 40 mg daily or ZA with placebo for six treatment cycles.
Zoledronic acid 4 mg was administered by intravenous infusion over 15 minutes. Simvastatin 40 mg or an identical placebo tablet was administered orally once daily at night. Each treatment cycle was separated by three weeks.
Placebo tablets were prepared by the hospital pharmacy to be identical in appearance, size, and colour to simvastatin tablets. Treatment allocation was concealed from both patients and investigators throughout the study. Patient adherence to the oral medication was monitored using self-reported patient diaries reviewed at each clinic visit.
Clinical efficacy was assessed using the Visual Analog Scale (VAS) pain score. Radio-imaging efficacy was evaluated using bone scintigraphy according to the MD Anderson criteria. Biological efficacy was assessed by measuring serum Dkk-1 and TRACP-5b at baseline and after the sixth treatment cycle. Safety and tolerability were evaluated throughout treatment using clinical and laboratory assessments, with adverse events graded according to CTCAE version 4.03.
As a pilot trial, the study was not powered to establish definitive efficacy. The estimates were intended to inform the design and sample size of a future adequately powered trial.
- Conditions
- Breast Cancer With Bone Metastasis
- Being tested
- Simvastatin, Placebo, Zoledronic Acid (Zometa)
- Keywords
- Breast Cancer, Bone Metastasis, Zoledronic Acid, Simvastatin, Biphosphonate, Dickkopf-1, Dkk-1, TRACP-5b
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
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
PlaceboDrug
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)Drug
Zoledronic acid 4 mg was administered as an intravenous infusion over 15 minutes for six treatment cycles, with each cycle separated by three weeks.
| Study group | Role | What they receive |
|---|---|---|
| ZA + Simvastatin | Experimental | 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. Receives: Drug: Simvastatin; Drug: Zoledronic Acid (Zometa) |
| ZA + Placebo | Placebo comparator | 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 Receives: Drug: Placebo; Drug: Zoledronic Acid (Zometa) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum DKK-1 Level
Change in serum Dkk-1 concentration from baseline to the end of treatment following six treatment cycles
Measured: Baseline to the end of Cycle 6 (each cycle is 21 days)
Secondary outcomes (4)
Change in VAS pain Score
Pain was assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, with higher scores indicating greater pain.
Measured: Baseline, end of Cycle 3, and end of Cycle 6 (each cycle is 21 days)
Bone Scan Response
Bone scan response categorized as responsive, stable disease, or progressive disease.
Measured: At the end of Cycle 6 (each cycle is 21 days)
Change in serum TRAcP-5b level
Change in serum TRACP-5b concentration from baseline to the end of treatment.
Measured: Baseline to the end of Cycle 6 (each cycle is 21 days)
Safety and Tolerability
Incidence and severity of treatment-related adverse events during the study, including hematological, non-hematological, musculoskeletal, renal, bisphosphonate-related, and statin-associated toxicities. Adverse events were graded according to CTCAE version 4.03.
Measured: Throughout the six treatment cycles (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start10 Apr 2021
- Primary completion10 Apr 2023
- Study completion20 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer With Bone MetastasisStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of two parallel treatment groups: zoledronic acid plus simvastatin or zoledronic acid plus placebo. Both groups received treatment for six cycles, with each cycle separated by three weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. dr. Erwin Danil Yulian, Sp.B (K) Onk, Universitas Indonesia
- Investigators
- Alvita Dewi Siswoyo, MD, Study director, Nuclear Medicine Division, Department of Radiology, Faculty of Medicine, Universitas Indonesia-dr. Cipto Mangunkusumo National General Hospital, Jakarta, IndonesiaMuhammad Ilyas, MD, Study director, cOccupational Medicine Division, Department of Community Medicine, Faculty of Medicine, Universitas Indonesia-dr. Cipto Mangunkusumo National General Hospital, Jakarta, IndonesiaMatahari Widyarani, MD, Study chair, dGeneral Practitioner, Research Assistant in Surgical Oncology Division, Faculty of Medicine, Universitas Indonesia-dr. Cipto Mangunkusumo National General Hospital, Jakarta, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823751
- Sponsor's protocol ID
- IndonesiaU2021
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07823751
- Acronym / sponsor ID
- IndonesiaU2021
- Conditions
- Breast Cancer With Bone Metastasis
- Keywords
- Breast Cancer, Bone Metastasis, Zoledronic Acid, Simvastatin, Biphosphonate, Dickkopf-1, Dkk-1, TRACP-5b
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 20 Jun 2026 (actual)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This was a prospective, single-center, randomized, double-blind, placebo-controlled pilot trial involving women with breast cancer and confirmed bone metastases. Participants were randomized to receive either zoledronic acid (ZA) in combination with simvastatin 40 mg daily or ZA with placebo for six treatment cycles.
Zoledronic acid 4 mg was administered by intravenous infusion over 15 minutes. Simvastatin 40 mg or an identical placebo tablet was administered orally once daily at night. Each treatment cycle was separated by three weeks.
Placebo tablets were prepared by the hospital pharmacy to be identical in appearance, size, and colour to simvastatin tablets. Treatment allocation was concealed from both patients and investigators throughout the study. Patient adherence to the oral medication was monitored using self-reported patient diaries reviewed at each clinic visit.
Clinical efficacy was assessed using the Visual Analog Scale (VAS) pain score. Radio-imaging efficacy was evaluated using bone scintigraphy according to the MD Anderson criteria. Biological efficacy was assessed by measuring serum Dkk-1 and TRACP-5b at baseline and after the sixth treatment cycle. Safety and tolerability were evaluated throughout treatment using clinical and laboratory assessments, with adverse events graded according to CTCAE version 4.03.
As a pilot trial, the study was not powered to establish definitive efficacy. The estimates were intended to inform the design and sample size of a future adequately powered trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel treatment groups: zoledronic acid plus simvastatin or zoledronic acid plus placebo. Both groups received treatment for six cycles, with each cycle separated by three weeks.
| Arm | Type | Receives |
|---|---|---|
| ZA + Simvastatin | Experimental | Drug: Simvastatin, Drug: Zoledronic Acid (Zometa)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. |
| ZA + Placebo | Placebo comparator | Drug: Placebo, Drug: Zoledronic Acid (Zometa)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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- Pregnancy or lactation.
- Prior or ongoing simvastatin or other statin treatment.
- Known hypersensitivity to bisphosphonates.
- Allergy to statins.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimvastatinSimvastatin 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 | Drug | ZA + Simvastatin |
| PlaceboAn 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. | Drug | ZA + Placebo |
| 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. | Drug | ZA + Placebo, ZA + Simvastatin |
Primary outcome
Change in Serum DKK-1 Level
Time frame: Baseline to the end of Cycle 6 (each cycle is 21 days)
Change in serum Dkk-1 concentration from baseline to the end of treatment following six treatment cycles
4 secondary outcomes
Change in VAS pain Score
Time frame: Baseline, end of Cycle 3, and end of Cycle 6 (each cycle is 21 days)
Bone Scan Response
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Change in serum TRAcP-5b level
Time frame: Baseline to the end of Cycle 6 (each cycle is 21 days)
Safety and Tolerability
Time frame: Throughout the six treatment cycles (each cycle is 21 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alvita Dewi Siswoyo, MD study director
Nuclear Medicine Division, Department of Radiology, Faculty of Medicine, Universitas Indonesia-dr. Cipto Mangunkusumo National General Hospital, Jakarta, Indonesia
Muhammad Ilyas, MD study director
cOccupational Medicine Division, Department of Community Medicine, Faculty of Medicine, Universitas Indonesia-dr. Cipto Mangunkusumo National General Hospital, Jakarta, Indonesia
Matahari Widyarani, MD study chair
dGeneral Practitioner, Research Assistant in Surgical Oncology Division, Faculty of Medicine, Universitas Indonesia-dr. Cipto Mangunkusumo National General Hospital, Jakarta, Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simvastatin and Zoledronic Acid (Zometa) in people with Breast Cancer With Bone Metastasis, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum DKK-1 Level (time frame: Baseline to the end of Cycle 6 (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.