EUCTR2006-005581-39-CZ进行中（未招募）不适用
A double-blind, multicenter, international randomised study to assess the effects of 6 months or 12 months administration of 2g per day of strontium ranelate versus alendronate 70mg per week on bone remodelling and bone safety assessed by histomorphometry in women with postmenopausal osteoporosis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 285
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •. Women of at least 50 years
- •. Postmenopausal for at least 3 years
- •. Osteoporotic:
- •- T-score at the L1-L4 spine and /or Femoral Neck £ -2.5 SD, corresponding to a lumbar mean BMD of all assessable vertebrae between L1 and L4 < 0.772 g/cm² and/or a femoral neck mean BMD < 0.572 g/cm² for Hologic apparatus, or corresponding to a lumbar mean BMD of all assessable vertebrae between L1 and L4 < 0.880 g/cm² and/or a femoral neck mean BMD < 0.680 g/cm² for LUNAR apparatus .
- •- T-score at the L1-L4 spine and /or Femoral Neck £ -1 SD and at least one prevalent low trauma fracture, corresponding to a lumbar mean BMD of all assessable vertebrae between L1 and L4 < 0.937 g/cm² and/or a femoral neck mean BMD < 0.738 g/cm² for Hologic apparatus, or corresponding to a lumbar mean BMD of all assessable vertebrae between L1 and L4 < 1.060 g/cm² and/or a femoral neck mean BMD < 0.860 g/cm² for LUNAR apparatus .
- •At least 2 vertebrae must be assessable between L1 and L4; if less than 2 vertebrae are assessable, the T-score will be considered only at the Femoral Neck.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •. Any medical or anatomical condition that potentially could put the patient at additional risk of an adverse event due to the biopsy procedure or that potentially could lead to an impossibility to perform a transiliac bone biopsy on each side
- •. Previous and concomittant treatments interfering with bone metabolism
研究者
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