Randomized, Double-blinded, Placebo Controlled Study to Assess Efficacy of Oral 35 mg Per Week Risedronate in Preventing Bone Loss in Postmenopausal Women With Aromatase Inhibitor Therapy for Breast Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evolution of the lumbar spine Bone Mineral Density after one year of treatment
研究概览
简要总结
Aromatase inhibitor therapy is in France the adjuvant reference treatment for postmenopausal women with early-stage breast cancer. This treatment induces bone loss and a higher risk of fractures.
This study aimed to document the effect of bisphosphonate therapy in preventing bone loss and osteoporotic fractures in postmenopausal women with aromatase inhibitor treatment for breast cancer
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women (more than one year since last menstrual period or removal of ovarian function by surgical or radiotherapic means)
- •Operated for an invasive breast cancer (histologically proven)
- •Surgical treatment completed and cycles of adjuvant chemotherapy (if necessary) completed
- •Treated with aromatase inhibitor
- •Osteopenic (-2.5<T score<-1) without osteoporotic fracture
- •With written informed consent signed
- •With social security
排除标准
- •Women presenting a history of osteoporotic fracture or a T score less than -2.5 at at least one measure site
- •Women presenting clinical signs of metastases
- •Having received other hormonal treatment in the last 3 months
- •Having received treatment by bisphosphonates, raloxifene, tamoxifen, parathormone, strontium ranelate, tibolone,calcitonin and corticosteroids at more than 5mg/d for 3 months in the last year
- •Presenting a known and untreated hyperthyroid
- •Presenting a known hyperadrenocorticism
- •Patients treated and followed for Paget's disease of bone
- •Presenting a untreated primary hyperparathyroid
- •Presenting an indication against risedronate (known hypersensibility to risedronate monosodium and/or one of its excipients, non-corrected hypocalcemia, pregnancy or breast feeding, severe renal insufficiency inferior to 30 ml/min)
- •Patients presenting malabsorption syndrome for glucose/galactose
- •Person participating in another clinical trial concerning a medicine susceptible to influence bone mass
研究组 & 干预措施
2
Patients receive placebo 35 mg once a week plus a calcium and vitamin D supplementation.
Measure of bone density, bone markers, clinical examination and questionnaire regarding fractures will be assessed at 12 and 24 months of treatment
干预措施: Placebo (Drug)
1
Patients receive risedronate 35 mg once a week plus a calcium and vitamin D supplementation.
Measure of bone density, bone markers, clinical examination and questionnaire regarding fractures will be assessed at 12 and 24 months of treatment
干预措施: Risedronate (Drug)
结局指标
主要结局
Evolution of the lumbar spine Bone Mineral Density after one year of treatment
时间窗: 1 year
次要结局
- Evolution of femoral BMD after one year of treatment(1 year)
- Evolution of lumbar spine and femoral BMD after two years of treatment(2 years)
- Evolution of bone resorption and formation markers(2 years)
- Proportion of fractures after two years of treatment(2 years)
- Evolution of estradiol levels(2 years)