Randomized controlled trial comparing Strontium-89 plus zoledronic acid with zoledronic acid alone as a treatment in patients with painful bone metastatic breast cancer

Randomized controlled trial comparing Strontium-89 plus zoledronic acid with zoledronic acid alone as a treatment in patients with painful bone metastatic breast cancer - JONIE 2 Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009756

Enrollment

Registered

2013-01-11

Start date

2012-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

Patients receive zoledronic acid 4mg function IV over 15 minutes infusion every 3-4 weeks for 12weeks (4-5 times infusion). Patients receive strontium-89 2MBq/kg(maximum 141MBq) 1-2 miminutes iv on

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1)Cases of diagnosed breast cancer with bone metastases 2)Cases of diagnosed bone metastases by bone scintigraphy 3)ECOG performance status(PS)is 0 to 2 4)Cases of painful bone metastasis or using analgesic drug for bone pain and well contolled 5)Cases under chemotherapy or previous radiation therapy from outside of the body 6)serum creatinine is lower than 1.2 mg/dL, creatinine clearance is higher than 60mL/min 7)WBC count is higher than 3,000/mm3, Neutrophil count is higher than 1,500/mm3, Platelet count is higher than 75,000/mm3, Hemoglobin count is lower than 9.0g/dL 8)Not DIC 9)Patients with life expectancy of 12 weeks or longer from the initial registration. 10)Women at least 18 years of age 11)Patients who submitted written informed consent signed by the patient.

Exclusion criteria

Exclusion criteria: 1)Cases with serious myelosupression 2)Cases with serious renal disorder 3)Cases with serious infection or interstitial pneumonia or pulmonary fibrosis 4)Cases with serious drug allergy 5)Cases in use of Denosumab 6)Pregnant patients or patients with possible pregnancy 7)Cases with active primary cancer without bone metastasis 8)Cases under invasive treatment of teeth 9)Cases that the investigator (subinvestigator) judged as inappropriate as the subject of this clinical study

Design outcomes

Secondary

Measure	Time frame
Time to SRE were assessed Dosing of analgesic drug pain free of proportion patients changes of bone resorption marker Time to additional therapy to bone changes of tumor marker QOL Adverse events	—

Primary

Measure	Time frame
Changes the proportion of patients uNTX at week13 Changes the proportion of patients BPI	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026