NCT01623908终止不适用
An Open,Multicentre,Prospective Study of Adjuvant Zoledronate Treatment in Osteoporosis Women With Breast Cancer
First Affiliated Hospital, Sun Yat-Sen University10 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Change from Baseline in Bone Mineral Density
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, age >
- •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-
- •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.
排除标准
- •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.
研究组 & 干预措施
Zoledronate
Experimental
干预措施: Zoledronate (Drug)
结局指标
主要结局
Change from Baseline in Bone Mineral Density
时间窗: 48 weeks
次要结局
- Bone metastasis rate(From date of randomization until the date of bone metastasis, assessed up to 48 weeks.)
- Disease-Free Survival(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)
研究者
Ying Lin
Associate Professor
First Affiliated Hospital, Sun Yat-Sen University
研究点 (10)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Zoledronic Acid in Patients With Bone Metastases of Any Solid Tumors or Multiple MyelomaTreatment of Bone MetastasesNCT00219258Novartis240
Unknown
2 期
Zoledronic Acid for the Prevention of Bone Loss Post-bone Marrow Transplantation for Thalassemia Major PatientsBeta-ThalassemiaBone Marrow TransplantationNCT01016093Tehran University of Medical Sciences50
已完成
3 期
Zoledronic Acid - Letrozole Adjuvant Synergy Trial (ZFAST) - Cancer Treatment Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Adjuvant Hormonal TherapyBreast NeoplasmsOsteoporosisNCT00050011Novartis Pharmaceuticals602
已完成
3 期
Zoledronate, Calcium, and Vitamin D in Preventing Bone Loss in Women Receiving Adjuvant Chemotherapy for Breast CancerBreast CancerOsteoporosisNCT00022087Alliance for Clinical Trials in Oncology439
已完成
2 期
Zoledronic Acid for Prevention of Bone Loss After BAriatric Surgery (ZABAS)Bone LossMuscle AtrophyBariatric SurgeryNCT04742010Stinus Gadegaard Hansen59