EUCTR2016-002964-15-GB进行中（未招募）1 期
The Effect of Selenium Supplementation on Musculoskeletal Health in Older WomenDouble-blind, randomised, placebo-controlled trial - Selenium and musculoskeletal health
Sheffield Teaching Hospitals0 个研究点目标入组 120 人开始时间: 2016年10月11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
- 入组人数
- 120
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
- •Aged over 55, and at least 5 years since last menstrual period.
- •Osteopenia or osteoporosis (DXA BMD T-score between -1.0 and -3.0 at lumbar spine or total hip), who do not require pharmacological treatment for fracture prevention
- •Willing and able to give informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Diabetes mellitus
- •Thyroid dysfunction (history of hyper- or hypothyroidism, or TSH outside the STH reference range)
- •any conditions known to affect bone metabolism:
- •- inflammatory disease (inflammatory arthritis, inflammatory bowel disease)
- •- parathyroid disease
- •- malabsorption (coeliac disease, pancreatic exocrine insufficiency)
- •- Women taking calcium and vitamin D supplements will not be excluded as long as they have been taking the calcium and vitamin D for at least 60 days and are planning to continue throughout the trial.
- •- alcohol intake >21 units per week
- •- prolonged immobility (in bed or using a wheelchair for more than three months within the last five years)
- •- fracture in the last year
- •Taken selenium supplements in the last 60 days (women who are taking selenium supplements but want to participate in the trial will be offered the option to stop their supplement and have a 60 day washout before screening).
- •Previous adverse reaction to selenium or any of the IMP or placebo excipients
- •Current or recent medications known to affect bone metabolism:
- •- Bisphosphonates (12m before)
- •- Teriparatide (12m before)
- •- Denosumab (12m before)
- •- Oestrogen or any sex steroids (12m before)
- •- Aromatase inhibitors (12m before)
- •- Tamoxifen or raloxifene (12m before)
- •- Active vitamin D metabolites; calcitriol, 1a-calcidol (6m before)
- •- Anti-epileptics; phenytoin, carbamazepine, primidone, valproate (6m before)
- •- Oral, IM or IV glucocorticoids (6m before)
研究者
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