Bone Loss Treatment From Adjuvant Zoledronate Efficacy (BLAZE)

June 19, 2021 updated by: Ying Lin, First Affiliated Hospital, Sun Yat-Sen University

An Open,Multicentre,Prospective Study of Adjuvant Zoledronate Treatment in Osteoporosis Women With Breast Cancer

The main purpose of this study is to observe and assess the impact of adjuvant zoledronate on bone density in breast cancer patients.

The second purposes:

  • The efficacy of adjuvant zoledronate
  • The safety of adjuvant zoledronate
  • The bone loss of breast cancer patients in Guangdong
  • The correlation between bone loss of breast cancer patients and treatment of disease in Guangdong

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Breast cancer is the most commonly diagnosed malignant disease and the leading cause of cancer-related mortality among women.

Zoledronate is a bone-targeted bisphosphonate, which is used to treat osteoporosis and to reduce the risk of skeletal morbidity in patients with bone metastases. Zoledronate can also reduce the persistence of disseminated tumour cells in the bone marrow of women with early-stage breast cancer. Nowadays, consensus is emerging that certain subsets of patients with early-stage breast cancer may benefit from bisphosphonate therapy.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Dongguan, Guangdong, China, 523059
        • Dongguan people's hospital
      • Guangzhou, Guangdong, China, 510180
        • Guangzhou First Municipal People's Hospital
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-Sen University Cancer Center
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510080
        • Guangdong General Hospital
      • Guangzhou, Guangdong, China, 510010
        • General Hospital of Guangzhou Military Command of PLA
      • Guangzhou, Guangdong, China, 510120
        • Guangdong Hospital of Traditional Chinese Medicine
      • Guangzhou, Guangdong, China, 510630
        • The First Affiliated Hospital of Jinan University
      • Shenzhen, Guangdong, China
        • Shenzhen Second Municipal People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female, age > 18.
  • Postoperative breast cancer patients who have finished adjuvant chemotherapy or unwilling to receive chemotherapy.
  • T score < -2.0, or -2.0 < T score <-1.0 with any 2 of the following risk factors: T score < -1.5, age > 65, BMI < 20kg/m^2, family history of hip fractures, age > 50 with brittle fracture history, oral steroid therapy > 6 months, receiving aromatase therapy.
  • ECOG(Eastern Cooperative Oncology Group) physical state score:0-2.
  • Breast cancer stage I-III confirmed by histological or cytological examination.
  • Patients received radical surgery with estimated survival time > 12 months.
  • Laboratory tests should be performed 1 week before enrollment and the results should meet the following criteria: neutrophil count ≥ 1.5×10^9/L, platelet count ≥ 100×10^9/L, hemoglobin ≥ 80g/L, serum bilirubin ≤ 1.0×ULN, AST and ALT ≤ 1.5×ULN, Serum creatinine ≤ 1.0×ULN.
  • Patients who never received intravenous bisphosphonate within 12 months before enrollment and did not receive oral bisphosphonate within 3 weeks before enrollment.
  • Informed consents should be signed by the participants or their guardians. All the participants should be aware of the purpose and procedure of this study and willing to participate in this study.
  • Contraception required for those reproductive-aged women.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Patients who have not signed informed consent.
  • Patients received medical treatment which can affect bone metabolism (such as calcitonin, mithramycin or gallium nitrate) within 2 weeks before enrollment.
  • Bone metabolic diseases such as Paget's disease, epiphyseal dysplasia and primary or secondary hyperthyroidism diagnosed within 12 months before enrollment.
  • Liver function impairment which is defined as 2.5-fold or more increase in ALT or AST levels compared with the upper limit of reference range.
  • Refuse appropriate contraception (appropriate contraceptive options include female sterilisation, intrauterine device, oral contraceptives and barrier contraception).
  • Active dental diseases including dental infection, mandibular pain and maxillary or mandibular trauma. Patients with mandibular osteonecrosis diagnosed currently or previously, exposed bone or slow healing after oral surgery. Patients who will receive dental or maxillofacial surgery (such as dental extraction and dental implant) in the first 6 weeks after enrollment.
  • Patients with dysgnosia or communication disorder who can't well understand our study, cooperate with our staff or operate glucose monitor correctly.
  • Combined with major organ dysfunction or other severe diseases such as severe coronary disease, cardiovascular disease, myocardial infarction occurred within 12 months before enrollment, severe neurological or psychiatric diseases, severe infection or active disseminated intravascular coagulation.
  • Alcoholics or drug addicts.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zoledronate
Drug: Zoledronate
4mg, IV (in the vein) every 6 months. Number of Cycles: up to the researcher or until unacceptable toxicity develops.
Other Names:
  • Zometa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Bone Mineral Density
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Bone metastasis rate
Time Frame: From date of randomization until the date of bone metastasis, assessed up to 48 weeks.
From date of randomization until the date of bone metastasis, assessed up to 48 weeks.
Disease-Free Survival
Time Frame: From date of randomization until the date of bone metastasis or date of death from any cause, whichever came first, assessed up to 48 weeks
From date of randomization until the date of bone metastasis or date of death from any cause, whichever came first, assessed up to 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Study Chair: Shenming Wang, MD, PhD, First Affiliated Hospital, Sun Yat-Sen University
  • Principal Investigator: Ying Lin, MD, PhD, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 16, 2012

First Submitted That Met QC Criteria

June 19, 2012

First Posted (Estimate)

June 20, 2012

Study Record Updates

Last Update Posted (Actual)

June 22, 2021

Last Update Submitted That Met QC Criteria

June 19, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110618GD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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