Study for Improving Life Quality in Breast Cancer Women Treated With Aromatase Inhibitors: Cohort B-ABLE
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Bone Mineral Strength (BMSi)
研究概览
简要总结
The main objective of the study is to improve the life quality of women treated with AI. Cohort B-ABLE is designed to evaluate musculoskeletal events derived of using AI in breast cancer women. The project objectives are the analysis of the AI deleterious effect on bone microarchitecture and early determination of the risk of fragility fracture with dual energy x-ray absorptiometry (DEXA), lumbar spine Rx, Trabecular Bone Score (TBS) and microindentation. Determination of physiological causes of the AI-related arthralgia by analyzing joint degradation markers, steroid hormone levels remaining in blood and functional magnetic resonance, before and after three months of AI treatment
详细描述
Postmenopausal women with breast cancer treated with aromatase inhibitors (AI) have a higher incidence of osteoporosis, fractures and other musculoskeletal symptoms, particularly pain and stiffness. B-ABLE is a clinical, prospective cohort study carried out in both Breast Cancer and Bone Metabolism Units of the Hospital del Mar in Barcelona. Currently, 780 postmenopausal Caucasian women with early breast cancer and candidates for adjuvant AI treatment were included and predicted to reach more than 1000 patients. The main objective of the study is to improve the life quality of women treated with AI. Cohort B-ABLE is designed to evaluate musculoskeletal events derived of using AI in breast cancer women. The project objectives are the analysis of the AI deleterious effect on bone microarchitecture and early determination of the risk of fragility fracture with DEXA, lumbar spine Rx, TBS and microindentation. Determination of physiological causes of the AI-related arthralgia by analyzing joint degradation markers, steroid hormone levels remaining in blood and functional magnetic resonance, before and after three months of AI treatment. The study results will help to decide the most appropriate treatment for each patient in order to minimize AI-related side effects and hence avoid discontinuation of adjuvant therapy treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women with early breast cancer estrogen receptor with aromatase inhibitors treatment
排除标准
- •Previous treatment with antiresorptive treatment for osteoporosis secondary osteoporosis, as corticosteroids, Hyperparathyroidism, Kidney Chronic disease, previous treatment with aromatase inhibitors Diabetes mellitus type 1 Fibromyalgia
研究组 & 干预措施
AI with osteoporosis
Patients with osteoporosis receive intervention with antiresorptive treatment, bisphosphonates or denosumab . All patients receive calcium and Vit D supplements All patients receive by protocol aromatase inhibitors for breast cancer treatment, letrozole, exemestane for 5 o 10 years.
干预措施: bisphosphonate (Drug)
结局指标
主要结局
Bone Mineral Strength (BMSi)
时间窗: change from baseline, 12 months, and 60 months of aromatase treatment
bone microindentation
Arthralgia
时间窗: change from baseline, 12 months, 24 months, 36 months, 48 months 60 months and 1 year after completion of aromatase treatment
joint pain measured by analogic visual scale range 0= no pain 10= worse pain
Fragility fractures assessed by xRay
时间窗: incidence of new fractures at 12 months, 24 months, 36 months, 48 months 60 months of aromatase treatment
vertebral and non vertebral fractures, hip fractures
bone mass measured by dual energy x-ray absorptiometry (DEXA) densitometry
时间窗: change from baseline, 12 months, 24 months, 36 months, 48 months 60 months and 1 year after completion of aromatase treatment
bone mas normal, osteopenia or osteoporosis related with WHO definition of osteoporosis and Trabecular Bone Score: normal, mild degratation and high degradation
次要结局
- bone turnover markers(change from baseline, 12 months, 24 months, 36 months, 48 months 60 months and 1 year after completion of aromatase treatment)
- cartilage degradation markers(change from baseline and 12 months of aromatase treatment)