Bone Loss Treatment From Adjuvant Zoledronate Efficacy (BLAZE)
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| ClinicalTrials.gov Identifier: NCT01623908 |
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Recruitment Status : Unknown
Verified October 2012 by Ying Lin, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was: Recruiting
First Posted : June 20, 2012
Last Update Posted : October 18, 2012
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Sponsor:
First Affiliated Hospital, Sun Yat-Sen University
Information provided by (Responsible Party):
Ying Lin, First Affiliated Hospital, Sun Yat-Sen University
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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 |
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 (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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
Drug Information available for:
Zoledronic acid
| 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 |
Primary Outcome Measures :
- Change from Baseline in Bone Mineral Density [ Time Frame: 48 weeks ]
Secondary Outcome Measures :
- Bone metastasis rate [ Time Frame: 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01623908
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 |
| 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 Key Record Dates |
| Last Update Posted: | October 18, 2012 |
| Last Verified: | October 2012 |
Keywords provided by Ying Lin, First Affiliated Hospital, Sun Yat-Sen University:
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Breast neoplasms Zoledronate Bone loss |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Zoledronic acid Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs |