EUCTR2005-003138-16-GB进行中（未招募）1 期
A clinical observational study to assess the effectiveness of Strontium Ranelate on bone protection in osteoporotic patients pre-treated with bisphosphonates. - Strontium following bisphosphonate therapy
R+ D department, Hull and East Yorkshire NHS Hospital Trust0 个研究点目标入组 0 人开始时间: 2005年7月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
入选标准
- •1) - Age: 50-75
- •2) - T score: <-2.5 at either hip or spine or a T score <2.0 and one BMD independent risk factor for fracture (previous osteoporotic fracture, maternal osteoporotic fracture, previous steroid use, BMI <19, untreated premature menopause) (typical criteria for patients considered as requiring treatment to reduced their risk of fracture).
- •3)-Fit into group 1 or 2 below:
- •Group1: no previous bisphosphonates.
- •Group 2: > 1 year treatment with oral bisphosphonates and stopped treatment within the last 1 month due to lack of effect or side effects. Also if treated with pamidronate for > 1 year and last infusion within the last 3 month. (to allow clear distinction between the study groups)
- •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
- •Significant renal disease. (creatinine clearance < 30 ml/min)
- •Prior treatment with Strontium Ranelate.
- •Active malignancy
- •Osteomalacia
- •Primary hyperparathyroidism
- •Patient is unable to give informed consent
研究者
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