NCT00409032已完成2 期
A Dose-response Study With Strontium Malonate in Postmenopausal Women. A 12 Week, Multi National, Double Blind, Randomized, 5 Arms, Parallel Group Placebo Controlled Open Label Active Controlled, Phase II Study With 3 Dose Levels of Strontium Malonate and Protelos Within Post Menopausal Women With a BMDT-score Below -1
Osteologix17 个研究点 分布在 2 个国家目标入组 275 人开始时间: 2006年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 275
- 试验地点
- 17
- 主要终点
- CTX-1
研究概览
简要总结
The primary objective of the study is to compare dose-response effect of three dose levels of strontium malonate to placebo on bone resorption quantified by S-CTX-1 following 12 weeks of treatment.
详细描述
275 post menopausal women are treated with either 750 mg strontium malonate, 1000 mg strontium malonate, 2000 mg strontium malonate, 2 g Protelos® or placebo.
Patients are treated for 12 weeks. A follow up period of 4 weeks is planned for the main study and a follow up period of 8 weeks is planned for approximately 20% of the patients to follow post treatment CTX-1 activity.
Apart from S-CTS-1 also response on other bio markers are evaluated as well as BMD.
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
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women (at least 12 months since last menstruation).
- •BMD (L2-4) T-score between -1 and -3 (at least 20% of the enrolled patients must have a BMD (L2-4) T-score below -2,5).
- •50 years of age.
- •BMI<30 kg/m
- •Total S-Ca level within normal range.
- •Ability to read and understand the information given.
- •The patient has signed an informed consent form according to ICH E6 and local requirements before any study specific procedure is carried out.
- •Ability to comply with study procedures.
排除标准
- •History of prior fragility fracture (any fracture in wrist, hip or spine appearing after 40 years of age).
- •History of alcohol or drug abuse.
- •Metabolic bone disease (e.g. pagets disease, bone cancer).
- •History of VTE/DVT.
- •History of kidney transplant.
- •Bilateral oophorectomy.
- •Relevant and treated reduced kidney or liver function.
- •Any malignancy within the last 5 years (except basal cell carcinoma)
- •Any chronic condition likely to affect absorption (e.g. Crohns disease, gluten enteropathy).
- •Known genetic pre-disposition to VTE/DVT
- •Known hypersensitivity to any of the active substances or excipients.
- •25-OH-vitamin D level below 25 nmol/L
- •Any previous treatment with bisphosphonates, Strontium or fluoride.
- •Treatment during the last 3 months affecting calcium balance or bone metabolism (e.g. thiazides, corticosteroids, calcitonin, HRT, SERMs, PTH, phosphorus).
- •Treatment during the last week with tetracycline, ciprofloxacin or loop diuretics.
- •PTH out of normal range
- •Use of any drug known to influence the coagulation process (aspirin and other NSAID allowed)
- •Prothrombin time out of normal range (sec or INR)
- •Inclusion in another clinical study within 30 days before randomization or during this study
结局指标
主要结局
CTX-1
次要结局
- Other bio markers, BMD
研究者
研究点 (17)
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