Bone Loss Treatment From Adjuvant Zoledronate Efficacy (BLAZE)

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Breast Neoplasms; Bone Loss	Drug: Zoledronate	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	200 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	An Open,Multicentre,Prospective Study of Adjuvant Zoledronate Treatment in Osteoporosis Women With Breast Cancer
Study Start Date :	July 2011
Estimated Primary Completion Date :	June 2014
Estimated Study Completion Date :	June 2017

Arms and Interventions

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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 Name: Zometa

Outcome Measures

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Primary Outcome Measures :

1. Change from Baseline in Bone Mineral Density [ Time Frame: 48 weeks ]

Secondary Outcome Measures :

1. Bone metastasis rate [ Time Frame: From date of randomization until the date of bone metastasis, assessed up to 48 weeks. ]
2. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Ying Lin	+86-20-87755766-8198	frostlin@hotmail.com

Locations

China, Guangdong
Dongguan People's Hospital	Recruiting
Dongguan, Guangdong, China, 523059
Contact: Ailing Zhang
General Hospital of Guangzhou Military Command of PLA	Recruiting
Guangzhou, Guangdong, China, 510010
Contact: Chenfang Zhang
Sun Yat-Sen University Cancer Center	Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Donggeng Liu
Guangdong General Hospital	Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Xuerui Li
Guangdong General Hospital	Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Ning Liao drliao_ning@hotmail.com
GuangDong Hospital Of Traditional Chinese Medicine	Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Qianjun Chen
Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Erwei Song songerwei02@yahoo.com.cn
Guangzhou First Municipal People's Hospital	Recruiting
Guangzhou, Guangdong, China, 510180
Contact: Li Zhao
Nanfang Hospital	Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Jianming Xie
The First Affiliated Hospital of Jinan University	Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Ningxia Wang
Shenzhen Second Municipal People's Hospital	Recruiting
Shenzhen, Guangdong, China
Contact: Xianming Wang

Sponsors and Collaborators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Ying Lin, Associate Professor, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:	NCT01623908 History of Changes
Other Study ID Numbers:	20110618GD
First Posted:	June 20, 2012
Last Update Posted:	October 18, 2012
Last Verified:	October 2012

Keywords provided by Ying Lin, First Affiliated Hospital, Sun Yat-Sen University:

Breast neoplasms; Zoledronate; Bone loss

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases	Zoledronic acid; Diphosphonates; Bone Density Conservation Agents; Physiological Effects of Drugs