Investigating Bone Density and Bone Loss Without Baseline Information
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 458
- 试验地点
- 16
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
排除标准
- 未提供
研究组 & 干预措施
Tamoxifen for 5 years
Patients treated with tamoxifen for 5 years after randomisation.
干预措施: laboratory biomarker analysis (Other)
Tamoxifen for 5 years
Patients treated with tamoxifen for 5 years after randomisation.
干预措施: Dual energy X-ray absorptiometry (DEXA) (Procedure)
Tamoxifen for 5 years
Patients treated with tamoxifen for 5 years after randomisation.
干预措施: Spine X-ray (Procedure)
Letrozole for 5 years
Patients treated with letrozole for 5 years after randomisation.
干预措施: laboratory biomarker analysis (Other)
Letrozole for 5 years
Patients treated with letrozole for 5 years after randomisation.
干预措施: Dual energy X-ray absorptiometry (DEXA) (Procedure)
Letrozole for 5 years
Patients treated with letrozole for 5 years after randomisation.
干预措施: Spine X-ray (Procedure)
Tamoxifen 2 years plus letrozole 3 years
Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years.
干预措施: laboratory biomarker analysis (Other)
Tamoxifen 2 years plus letrozole 3 years
Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years.
干预措施: Dual energy X-ray absorptiometry (DEXA) (Procedure)
Tamoxifen 2 years plus letrozole 3 years
Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years.
干预措施: Spine X-ray (Procedure)
Letrozole 2 years plus tamoxifen 3 years
Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.
干预措施: laboratory biomarker analysis (Other)
Letrozole 2 years plus tamoxifen 3 years
Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.
干预措施: Dual energy X-ray absorptiometry (DEXA) (Procedure)
Letrozole 2 years plus tamoxifen 3 years
Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.
干预措施: Spine X-ray (Procedure)
结局指标
主要结局
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
时间窗: 5 years after randomisation to BIG 1-98
Recovery of BMD at 1 year after the completion of treatment on protocol IBCSG-1-98
时间窗: 6 years after randomisation to BIG 1-98
Proportion of patients with BMD below the absolute threshold value for osteoporosis
时间窗: 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
时间窗: 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
时间窗: 6 years after randomisation to BIG 1-98
次要结局
未报告次要终点