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Bone Density and Bone Loss in Postmenopausal Women With Breast Cancer Receiving Treatment in Clinical Trial IBCSG-1-98

2012年7月26日 更新者：ETOP IBCSG Partners Foundation

Investigating Bone Density and Bone Loss Without Baseline Information

RATIONALE: Diagnostic procedures, such as bone mineral density testing and x-ray, help measure bone loss in women receiving treatment for breast cancer. The test results may help doctors plan better treatment.

PURPOSE: This phase III trial is studying bone density and bone loss in postmenopausal women with breast cancer receiving treatment in clinical trial IBCSG-1-98.

研究概览

地位

完全的

条件

干预/治疗

详细说明

OBJECTIVES:

  • Compare the effects on bone mineral density (BMD) in the L2-L4 (posterio-anterior) region of the spine and hip by assessing bone density in postmenopausal women with breast cancer receiving treatment on protocol IBCSG-1-98.
  • Compare the incidence of radiological gross changes and fractures identified from spine x-rays (T4-L4) in these patients (in groups 1 and 2).
  • Use longitudinal BMD measurements to estimate a linear rate of bone loss based on mixed effect models.
  • Identify serum markers for bone loss to determine how they correlate with osteoporosis, microfractures, clinical fractures, and breast cancer-related bone events.

OUTLINE: This is a multicenter study and a substudy of protocol IBCSG-1-98. Patients are assigned to 1 of 3 groups according to the length of treatment they have undergone on protocol IBCSG-1-98.

  • Group 1 (prior to or at the end of the second year of treatment on protocol IBCSG-1-98): Patients undergo bone mineral density (BMD) testing of the L2-L4 spine and hip at baseline and years 1, 2, 3, and 4 from baseline. They also undergo x-rays of the T4-L4 spine at baseline and years 1, 3, and 4 from baseline.
  • Group 2 (after 2 years but before the end of the third year of treatment on protocol IBCSG-1-98): Patients undergo BMD testing of the L2-L4 spine and hip at baseline and years 1, 2, and 3 from baseline. They also undergo x-rays of the T4-L4 spine at baseline and years 2 and 3 from baseline.
  • Group 3 (after 3 years but before the end of the fifth year of treatment on protocol IBCSG-1-98): Patients undergo BMD testing of the L2-L4 spine and hip at baseline and years 1 and 2 from baseline (for patients in 4th year of treatment) or year 1 from baseline (for patients in 5th year of treatment).

Patients undergo blood collection at baseline and periodically during study for biomarker correlative study.

PROJECTED ACCRUAL: A total of 660 patients will be accrued for this study.

研究类型

介入性

注册 (实际的)

458

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

  • 南非
      • Cape Town、南非、7925
        • Groote Schuur Hospital
  • 意大利
      • Aviano、意大利、33081
        • Centro di Riferimento Oncologico - Aviano
      • Bergamo、意大利、24100
        • Ospedali Riuniti di Bergamo
      • Milano、意大利、20141
        • European Institute of Oncology
  • 新西兰
      • Dunedin、新西兰
        • Dunedin Hospital
  • 法国
      • Bordeaux、法国、33076
        • Institut Bergonie
  • 澳大利亚
    • New South Wales
      • Randwick、New South Wales、澳大利亚、2031
        • Institute of Oncology at Prince of Wales Hospital
    • Queensland
      • Brisbane、Queensland、澳大利亚、4029
        • Royal Brisbane and Women's Hospital
  • 瑞士
      • Aarau、瑞士、CH-5001
        • Kantonspital Aarau
      • Bern、瑞士、CH-3010
        • Inselspital Bern
      • Lausanne、瑞士、CH-1011
        • Centre Hospitalier Universitaire Vaudois
      • Mendrisio、瑞士、CH-6850
        • Ospedale Beata Vergine
      • St. Gallen、瑞士、CH-9007
        • Kantonsspital - St. Gallen
      • Thun、瑞士、3600
        • Regionalspital
  • 秘鲁
      • Lima、秘鲁、34
        • Instituto Nacional de Enfermedades Neoplasicas
  • 西班牙
      • Madrid、西班牙、28034
        • Hospital Ruber Internacional

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

30年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

DISEASE CHARACTERISTICS:

  • Diagnosis of breast cancer

    • Resected disease

  • Enrolled on protocol IBCSG-1-98

    • Receiving adjuvant endocrine therapy comprising 1 of the following regimens:

      • Letrozole
      • Tamoxifen
      • Letrozole after 2 years of tamoxifen
      • Tamoxifen after 2 years of letrozole
    • Not yet completed 5 years of treatment
  • No breast cancer recurrence or second primary cancer
  • No known, symptomatic bone disease, including osteomalacia or osteogenesis imperfecta
  • No prior registration to protocol IBCSG-1-98 Bone Mineral Density substudy

  • Hormone receptor status:

    • Estrogen receptor-positive and/or progesterone receptor-positive tumor

PATIENT CHARACTERISTICS:

  • Female
  • Postmenopausal
  • No uncontrolled thyroid or parathyroid disease, Cushing's disease, or other pituitary diseases
  • No malabsorption syndrome or clinically relevant vitamin D deficiency
  • No patients for whom the bone density determination is impossible

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 1 year since prior and no concurrent anticonvulsants
  • More than 6 weeks since prior and no concurrent corticosteroids (at doses > the equivalent of 5 mg/day prednisone) for > 2 weeks total
  • No prior or concurrent sodium fluoride (at daily doses ≥ 5 mg/day) for > 1 month
  • More than 12 months since prior and no concurrent anabolic steroids
  • More than 6 months since prior treatment, either investigational or not, for the prevention of osteoporosis (excluding calcium or cholecalciferol [vitamin D])
  • No concurrent raloxifene
  • Concurrent therapeutic intervention for osteoporosis comprising bisphosphonates allowed
  • Concurrent warfarin allowed provided it is given for ≤ 4 weeks

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：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：他莫昔芬 2 年加来曲唑 3 年
患者用他莫昔芬治疗 2 年，然后用来曲唑治疗 3 年。
其他：laboratory biomarker analysis
Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.
程序：Dual energy X-ray absorptiometry (DEXA)
Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.
程序：Spine X-ray
Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.
实验性的：Tamoxifen for 5 years
Patients treated with tamoxifen for 5 years after randomisation.
其他：laboratory biomarker analysis
Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.
程序：Dual energy X-ray absorptiometry (DEXA)
Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.
程序：Spine X-ray
Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.
实验性的：Letrozole for 5 years
Patients treated with letrozole for 5 years after randomisation.
其他：laboratory biomarker analysis
Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.
程序：Dual energy X-ray absorptiometry (DEXA)
Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.
程序：Spine X-ray
Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.
实验性的：Letrozole 2 years plus tamoxifen 3 years
Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.
其他：laboratory biomarker analysis
Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.
程序：Dual energy X-ray absorptiometry (DEXA)
Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.
程序：Spine X-ray
Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Relative percent change of bone mineral density (BMD) form baseline to after 2, 3, 4, or 5 years of treatment on protocol IBCSG-1-98
大体时间：5 years after randomisation to BIG 1-98
5 years after randomisation to BIG 1-98
Recovery of BMD at 1 year after the completion of treatment on protocol IBCSG-1-98
大体时间：6 years after randomisation to BIG 1-98
6 years after randomisation to BIG 1-98
Proportion of patients with BMD below the absolute threshold value for osteoporosis
大体时间：5 years after randomisation to BIG 1-98
5 years after randomisation to BIG 1-98
Relative percent change in markers of bone resorption from baseline to after 2, 3, 4, or 5 years of treatment on protocol IBCSG-1-98
大体时间：5 years after randomisation to BIG 1-98
5 years after randomisation to BIG 1-98
Recovery of the markers of bone resorption at 1 year after the completion of treatment on protocol IBCSG-1-98
大体时间：6 years after randomisation to BIG 1-98
6 years after randomisation to BIG 1-98

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。

赞助

ETOP IBCSG Partners Foundation

调查人员

  • 学习椅：Stefan Aebi, MD、University Hospital Inselspital, Berne
  • 学习椅：Andrea Decensi, MD、European Institute of Oncology

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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

2004年5月1日

初级完成 (实际的)

2008年5月1日

研究完成 (实际的)

2012年1月1日

研究注册日期

首次提交

2006年8月24日

首先提交符合 QC 标准的

2006年8月24日

首次发布 (估计)

2006年8月29日

研究记录更新

最后更新发布 (估计)

2012年7月27日

上次提交的符合 QC 标准的更新

2012年7月26日

最后验证

2012年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CDR0000482381
  • NOVARTIS-2026703019 (其他标识符：Novartis)
  • IBCSG-18-98-BS (其他标识符：IBCSG)
  • EU-20623 (其他标识符：EU)
  • IBCSG-1-98-BS (其他标识符：IBCSG)

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.

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条件

罕见疾病

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3
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