TEXT-Bone: A Substudy of the TEXT Trial to Evaluate Serial Bone Markers for Bone Remodeling, Serial Growth Factors, and Bone Mineral Density
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 13
- 主要终点
- Serial serum levels of IGF-1 and IGFBP-3
研究概览
简要总结
RATIONALE: Gathering information over time from bone density and laboratory tests of women with breast cancer treated with triptorelin and tamoxifen or exemestane may help the study of breast cancer in the future.
PURPOSE: This clinical trial is studying changes in bone mineral density in women with breast cancer treated with triptorelin and tamoxifen or exemestane on protocol IBC SG-25-02 (TEXT).
详细描述
OBJECTIVES:
- Evaluate changes in bone mineral density (BMD) among premenopausal women randomized in protocol IBC SG-25202 (TEXT-2) to receive either: A) triptorelin (GnRH analogue) for 5 years plus tamoxifen for 5 years; or B) triptorelin (GnRH analogue) for 5 years plus the steroidal aromatase inhibitor exemestane for 5 years.
- Evaluate serial serum markers for bone remodeling (C-telopeptide, osteocalcin, bone-specific alkaline phosphatase) and investigate their correlation with BMD.
- Evaluate the relationship of genetic variants of CYP19A1, ERα, ERß, and IGF 1 with BMD.
- Evaluate serial serum growth factors (IGF-1 and IGFBP-3) and investigate whether their time course correlates with BMD.
- Explore the role of serum IGF-1 and IGFBP-3 as biomarkers of disease outcome (disease-free survival). (exploratory)
OUTLINE: Blood samples are collected at baseline and then periodically for 6 years. Serum markers of bone remodeling and serum growth factor levels are measured.
Bone mineral density in the L1-L4 (postero-anterior) region of the spine and femoral neck of the hip is measured by DEXA at baseline and then periodically for 6 years.
Any surplus serum is stored for use in unspecified future research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Patient must be eligible and enrolled in the TEXT-2 trial prior to enrolling in TEXT-Bone
- •Serial bone marrow density (BMD) measurements must be taken within the same institution
- •Hormone receptor positive
- •PATIENT CHARACTERISTICS:
- •See Disease Characteristics
- •Premenopausal
- •No bone fracture in the past 6 months that, in the investigator's judgement, could be related to bone fragility
- •No clinical or biochemical malabsorption syndrome, known vitamin D deficiency, active hyper- or hypoparathyroidism, or Paget's disease
- •No uncontrolled thyroid disease, Cushing disease, or other pituitary diseases
- •No other bone disease (including osteomalacia or osteogenesis imperfecta)
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 6 months since prior and no concurrent bisphosphonate therapy (or other bone therapies such as PTH or strontium)
- •At least 6 months since prior glucocorticoid (> 5 mg prednisone or equivalent) for > 1 month
- •At least 12 months since prior anticonvulsants
排除标准
- 未提供
研究组 & 干预措施
Triptorelin plus tamoxifen
Determination of bone mineral density in patients randomized in TEXT-1 or TEXT-2 trials to receive triptorelin (GnRH analogue) for 5 years plus tamoxifen for 5 years.
干预措施: laboratory biomarker analysis (Other)
Triptorelin plus tamoxifen
Determination of bone mineral density in patients randomized in TEXT-1 or TEXT-2 trials to receive triptorelin (GnRH analogue) for 5 years plus tamoxifen for 5 years.
干预措施: dual x-ray absorptiometry (Procedure)
Triptorelin plus exemestane
Determination of bone mineral density in patients randomized in TEXT-1 or TEXT-2 trials to receive triptorelin (GnRH analogue) for 5 years plus exemestane for 5 years.
干预措施: laboratory biomarker analysis (Other)
Triptorelin plus exemestane
Determination of bone mineral density in patients randomized in TEXT-1 or TEXT-2 trials to receive triptorelin (GnRH analogue) for 5 years plus exemestane for 5 years.
干预措施: dual x-ray absorptiometry (Procedure)
结局指标
主要结局
Serial serum levels of IGF-1 and IGFBP-3
时间窗: 72 months after randomization to TEXT Study
Serial serum levels of C-telopeptide, osteocalcin, and bone-specific alkaline phosphatase
时间窗: 72 months after rnadomization to TEXT Study
Serial BMD measurements of the L1-L4 (postero-anterior, PA) region of the spine and hip by dual-energy X-ray absorptiometry (DEXA)
时间窗: 72 months after randomization to TEXT Study
次要结局
未报告次要终点