Effect of Zoledronic Acid Treatment on Bone-related Events in Breast Cancer Patients With Bone Metastases: a Prospective, Multicenter, Real-world Study

NCT05480189 | Not Yet Recruiting

• 1 other identifier: IRB-2022-166
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

non-intervention、real world study； Effect of timing and regular treatment of zoledronic acid on the incidence of SREs in breast cancer patients

Conditions

Histologically Confirmed Breast Cancer ,Diagnosis of Bone Metastasis

Outcome Measures

Primary Outcomes (1)

• SREs

  skeletal-related events (SREs) including pathologic fracture, spinal cord compression, hypercalcemia of malignancy, and the need for radiotherapy and/or surgery to bone

  3 years

Secondary Outcomes (1)

• time to first on-study SRE

  3 years

Study Arms (1)

patients in breast cancer with bone metastasis

patients in breast cancer with bone metastasis

Other: Non-intervention

Interventions

Non-intervention OTHER

Non-intervention,with real world study

patients in breast cancer with bone metastasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Histologically confirmed breast cancer, Initial diagnosis of bone metastasis

You may qualify if:

• \. Age ≥18 years 2. Histologically confirmed breast cancer 3. Initial diagnosis of bone metastasis by MRI or CT and treatment with zoledronic acid 4. Serum creatinine ≤265mol/L or 3.0mg/dl 5. CrCl ≥ 30 ml/min 6. Serum Ca2+ concentration 2.0-3.0 mmonl/L 7.ECOG score ≤2 Voluntary research, informed consent

You may not qualify if:

• \. Pregnant and lactating women 2. Severe liver insufficiency (ALT and/or AST higher than 3 times the upper limit of normal) 3. Patients with osteoarthritis or other bone related diseases need bone targeted therapy 4. Patients with uncontrolled dental problems or planned jaw surgery

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Officials

• Xiaojia Wang, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaojia Wang, MD

CONTACT

13906500190; wxiaojia0803@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 29, 2022
• Study Start: August 30, 2022
• Primary Completion: August 30, 2023
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 29, 2022

Record last verified: 2022-07