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临床试验/EUCTR2007-004529-57-GB
EUCTR2007-004529-57-GB进行中(未招募)不适用

Vascular Pleiotrophic Effects of Bisphosphonates in Post Menopausal Women with Osteoporosis: Cellular Mechanisms and Functional Consequences - vascular Effects of Bisphosphonates in osteoporosis

Greenpark Healthcare Trust0 个研究点开始时间: 2007年10月16日最近更新:
适应症
相关药物

试验速览

阶段
不适用
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

性别
Female

入选标准

  • Inclusion Criteria:
  • Postmenopausal women aged 45 to 60 years of age.
  • T score at or below -2.5 standard deviations of the mean on DEXA scan.
  • 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) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Exclusion Criteria:
  • Women who are pregnant, lactating, not undertaking an acceptable form of contraception, have hypocalcaemia or severe renal impairment (a creatinine clearance less than 30ml/min)
  • Menopause before the age of 40 or surgical menopause.
  • Bone disorders other than osteoporosis.
  • Treatment within six months of study entry with androgen, calcitonin, estrogen, progesterone, fluoride in a tablet form, raloxifene, tamoxifen, lithium or anticonvulsants
  • Previous treatment with bisphosphonates or steroids.
  • Systolic blood pressure of >140 mm Hg or diastolic blood pressure >90 mm Hg at baseline screening examination determined as a mean of 3 readings.
  • History of myocardial infarction, angina, peripheral vascular disease, cerebrovascular disease or diabetes mellitus (fasting blood sugar >7.0mmol/l).
  • History of gastritis or gastro-oesophageal reflux disease.
  • Significant co-morbidity, malignancy or secondary causes of osteoporosis

研究者

发起方
Greenpark Healthcare Trust

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