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临床试验/NCT00760370
NCT00760370已完成2 期

Bone Retention of Bisphosphonate (Zometa) in Patients With Multiple Myeloma or Breast Cancer With Metastases to Bone

Vejle Hospital4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年12月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
60
试验地点
4
主要终点
Amount of Zometa retained in body

研究概览

简要总结

The investigators major aim is to determine whether there is a difference in the retention of zoledronic acid in multiple myeloma patients, compared to patients with breast cancer metastasis to bone. In addition the investigators wish to analyze if the retention of zoledronic acid is correlated to the extent of bone resorption/formation, and if there is a tendency to changes in retention with sequential treatment.

详细描述

The clinical benefit from treatment with bisphosphonates has been documented in a large number of clinical studies, and bisphosphonates are now widely used for treatment of pain and prevention of bone fractures or vertebral collapse for example in patients with cancer metastasis to bone or multiple myeloma.

Repeated intravenous administration of the more potent bisphosphonates (pamidronate and zoledronic acid) are often used for treatment of osteolytic disease caused by disseminated cancer or multiple myeloma, while the less potent oral bisphosphonates are often prescribed for treatment of benign osteoporosis. The recommended dose and time schedule for treatment with the more potent bisphosphonates is based on concerns of avoiding toxicity and at the same time obtaining maximal clinical benefit. Clinical studies in multiple myeloma and bone metastasis show significant activity of pamidronate (90 mg by iv infusion during 2-4 hours) or zoledronic acid (4 mg iv during 15 min) repeated every 4 weeks after a treatment period of 9 months and beyond, but the optimal duration of treatment is not known. This is a particular important issue since the use of potent bisphosphonates have been brought in connection with osteonecrosis.

In the present study we will compare the retention of Zometa with the effect on bone markers in patients with multiple myeloma or breast cancer with metastases to bone.

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

性别
Female
接受健康志愿者

入选标准

  • Patients diagnosed with breast cancer and metastases to bone.
  • Patients diagnosed with multiple myeloma.
  • Patients who are scheduled to receive Zometa.
  • Post-menopausal women (at least 10 months since last period).
  • Newly diagnosed patients must have clear signs of osteolysis.

排除标准

  • Anti-estrogen treatment.
  • Patients given chemotherapy during or less than 7 days before study begin.
  • Patients receiving glucocorticoids less than 5 days prior to study begin or during the study period (14 days)

结局指标

主要结局

Amount of Zometa retained in body

时间窗: 48 hrs

次要结局

  • Changes in bone markers(14 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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