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Fosamax for Childhood Cancer Survivors

2008年5月22日 更新者:Chinese University of Hong Kong

Randomized Controlled Study on the Benefits and Safety of Bisphosphonate Treatment in Childhood Cancer Survivors

Survivors of childhood cancers face a variety of long-term problems. The investigators' recent study found that osteoporosis and osteopenia were common among these patients. The factors leading to, as well as the best treatment option for, this morbidity are unclear. Bisphosphonates are currently the standard therapy for osteoporosis in the elderly. However, the efficacy and safety of bisphosphonates for treating osteoporosis in long-term cancer survivors have not been tested. The investigators hypothesize that alendronate, an orally active bisphosphonate, is efficacious and safe in the treatment of osteoporosis in these patients.

研究概览

详细说明

The modern treatment for childhood malignancy includes surgery and chemoradiotherapy either individually or in combination. Despite the great achievement in improving patient survival, these treatments also greatly enhance the adverse effects on the unfortunate children. Our research group has recently conducted a pioneer study on the bone mineralization and bone mineral density (BMD) study in longterm childhood cancer survivors in local patients who have completed anti-cancer treatment for at least five years. This landmark study showed that persistent treatment-related adverse effects on skeletal development are common (up to 50%) in local long-term survivors of childhood cancers. Thus, it is important during this critical period of rapid somatic growth in adolescents and young adults that these cancer survivors achieve their peak potential for bone mineralization and strengthening. In this proposed study, we investigate with a randomized and controlled study design on the efficacy of a second-generation oral bisphosphonate, alendronate, to improve BMD over a 36-week period in long-term survivors of childhood cancers in Hong Kong. In addition to alendronate, all subjects in the active and control groups will receive alfacalcidol (vitamin D) and calcium carbonate throughout the whole study period. The study results will help paediatric oncologists to decide on the optimal remedial treatments against osteoporosis in long-term cancer survivors.

研究类型

介入性

注册 (预期的)

100

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Hong Kong、香港
        • 招聘中
        • Prince of Wales Hospital, Shatin, N.T.
        • 副研究员:
          • Patrick MP Yuen, MD, FRCPC
        • 副研究员:
          • Chi Kong Li, MBBS, MD
        • 副研究员:
          • Christopher WK Lam, PhD
        • 副研究员:
          • Vincent Lee, MBChB

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

15年 及以上 (孩子、成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Chinese patients who completed treatments for childhood cancers for at least 5 years
  • Currently followed up in the Department of Paediatrics of Prince of Wales Hospital
  • Younger than 18 years old at the time of diagnosis of underlying cancers
  • Evidence of osteoporosis (i.e. BMD T- or Z-score < -2.5 at lumbar spine)
  • Older than 15 years of age at the time of recruitment

Exclusion Criteria:

  • Current treatment (i.e. within 6 months) with maintenance systemic or high-dose inhaled corticosteroids
  • Subjects who cannot cooperate for BMD measurements
  • Pregnant female patients
  • Subjects with prior history of allergy to alendronate or in whom alendronate treatment is contraindicated

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Alendronate
Oral alendronate 70 mg weekly
Alendronate 70 mg weekly (oral)
其他名称:
  • 福善美
安慰剂比较:Placebo
Conventional drug treatment
安慰剂

研究衡量的是什么?

主要结果指标

结果测量
大体时间
The percent change in bone mineral density (BMD) at lumbar spine at 36-weeks in subjects who receive active and control treatments
大体时间:36 weeks
36 weeks

次要结果测量

结果测量
大体时间
Changes in BMD at femoral neck
大体时间:36 weeks
36 weeks
Changes in biochemical markers of bone turnover
大体时间:36 weeks
36 weeks
Occurrence of clinical bone-related symptoms at 12-weeks and end of this study
大体时间:36 weeks
36 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ting Fan Leung, MBChB, MD、Department of Pediatrics, The Chinese University of Hong Kong

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2006年5月1日

研究完成 (预期的)

2008年10月1日

研究注册日期

首次提交

2006年10月23日

首先提交符合 QC 标准的

2006年10月23日

首次发布 (估计)

2006年10月24日

研究记录更新

最后更新发布 (估计)

2008年5月23日

上次提交的符合 QC 标准的更新

2008年5月22日

最后验证

2008年5月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

安慰剂的临床试验

3
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