NCT00458796终止不适用
Cost-Effective Use of Bisphosphonates in Metastatic Bone Disease - A Comparison of Bone Marker Directed Zoledronic Acid Therapy to a Standard Schedule
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,500
- 试验地点
- 30
- 主要终点
- Hypercalcemia of malignancy
研究概览
简要总结
RATIONALE: Zoledronic acid may help decrease the risk of broken bones, bone pain, and other symptoms caused by bone metastases. It may also help patients live more comfortably.
PURPOSE: This randomized clinical trial is studying different schedules of zoledronic acid to compare how well they work in treating patients with breast cancer that has spread to the bone.
详细描述
OBJECTIVES:
Primary
- Compare the frequency and timing of serious related events (e.g., fractures, radiotherapy to bone, hypercalcemia of malignancy, orthopedic surgery, and spinal cord compression) in patients with advanced breast cancer metastatic to the bone treated with bone marker-directed schedule vs standard schedule zoledronic acid.
Secondary
- Compare the quality of life of patients treated with these regimens.
- Compare the clinical burden of skeletal complications in these patients.
- Compare pain, performance status, and analgesic use (PPA score) in these patients.
- Compare the incidence of new bone metastases in these patients.
- Compare overall survival of these patients.
- Compare bisphosphonate use and expenditure on administration in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed primary breast cancer
- •Advanced disease
- •Radiographic confirmation of bone metastases (≥ 1 bone scan lesion must be confirmed as metastatic by plain radiographs or CT scan/MRI)
- •Must have received zoledronic acid to treat metastatic bone disease (i.e., ≥ 4 or 5 zoledronic acid treatments prior to study entry for patients receiving 4- or 3-weekly infusions, respectively) for ≥ 4 months prior to study entry
- •Any bisphosphonate to treat metastatic bone disease allowed provided it was not given for more than 12 months prior to study entry
- •No metabolic bone disease (e.g., Paget's disease of bone)
- •Osteoporosis allowed
- •No brain metastases
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Male or female
- •Menopausal status not specified
- •WHO or ECOG performance status 0-2
- •Life expectancy ≥ 6 months
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •AST and ALT ≤ 3 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •Creatinine clearance ≥ 30 mL/min
- •No poor venous access
- •No concurrent active dental problems, including infection of the teeth or jawbone (maxilla or mandibular)
- •No prior or current diagnosis of osteonecrosis of the jaw
- •No other cancer within the past 5 years except nonmelanomatous skin cancer, carcinoma in situ of the uterine cervix, or superficial bladder cancer treated with curative intent
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No other prior bisphosphonate treatment within the past 3 weeks
- •No treatment with systemic bone-seeking radioisotopes (e.g., strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium) within the past 3 months
- •No wide-field (hemibody) radiotherapy within the past 3 months
- •Recent standard-field, localized radiotherapy allowed
- •No dental or jaw surgery (e.g., extractions, implants) within the past 4 weeks
- •No other concurrent bisphosphonates
- •No concurrent medication with drugs known to affect bone metabolism (e.g., calcitonin or high-dose systemic corticosteroids [> 10 mg prednisolone/day or equivalent])
- •Systemic or oral corticosteroids allowed for clearly indicated conditions (e.g., chemotherapy-induced emesis, brain metastases, compression syndromes)
- •Concurrent chemotherapy, biological therapy, or endocrine therapy allowed
排除标准
- 未提供
结局指标
主要结局
Hypercalcemia of malignancy
Fractures
Radiotherapy to bone either for relief of pain or to treat or prevent pathological fractures or spinal cord compression
Orthopedic surgery to prevent or treat pathological fractures or spinal cord compression
Spinal cord compression
次要结局
- Quality of life as measured by QLQ-C30 and the QLQ-BR23 breast-specific module
- Clinical burden of skeletal complications
- Pain, performance status, and analgesic use
- Incidence of new bone metastases
- Overall survival
- Bisphosphonate use and expenditure on administration
- Health care utilization
- Clinical utility of the "point of care" test for N-telopeptides (NTx) excretion
研究者
研究点 (30)
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