EUCTR2008-001865-28-GB进行中（未招募）1 期
The Relationship between Osteoporosis and Aortic Calcification in Postmenopausal Women - Osteoporosis and Aortic Calcification
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 26
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
- •Ambulatory postmenopausal women.
- •Aged 50 years and over.
- •Lumbar spine, femoral neck or total hip bone mineral density measurement more than 2 standard deviations below the young adult mean for healthy women (T-score < -2).
- •Normal or clinically insignificant laboratory values.
- •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
- •Current or recent (within 1 year of enrolment) metabolic bone disorders other than postmenopausal osteoporosis including Paget's disease, renal osteodystrophy, osteomalacia or any other disease known to influence bone metabolism.
- •Treatment with oestrogens, progestins or selective estrogen receptor modulators (SERMS) for longer than 3 months in the past or within 3 months of study enrolement.
- •Previous or current use of oral or intravenous bisphosphonates.
- •Current treatment with corticosteroids, calcitonins, strontium ranelate, anticonvulsants, vitamin D >50,000IU/week, teripatide, PTH 1-84 or any other treatment known to influence bone metabolism.
- •Current use of lipid lowering agents.
- •Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achalasia
- •Hypersensitivity to alendronic acid or to any of the excipients
- •Hypocalcaemia
研究者
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