EUCTR2020-002934-34-DK进行中（未招募）1 期
The effects of melatonin treatment on bone, marrow, sleep and arterial stiffness in postmenopausal women
Aarhus University Hospital, dept. of Diabetes and Hormonal diseases0 个研究点目标入组 40 人开始时间: 2020年9月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
- •Postmenopausal women aged 55-75 years.
- •Written consent to participate
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Allergy towards study medicine
- •Allergy towards local anesthesia
- •Severely impaired renal function (eGFR <59 ml/l).
- •Treatment with antiresorptives within 5 years
- •Treatment with postmenopausal hormons within the last 2 years
- •Systemic treatment with glucocorticoids (duration >30 days) within the last year
- •Severely impaired hepatic function (Plasma alanine aminotransferase
- •(ALAT) and/or alkaline phosphatase more the dobbed compared to upper limit of reference value.
- •Hypercalcemia (p-ion calcium > 1.32 nmol/l)
- •Previous or present malignancies (except a treated skin cancer that is not melanoma or treated carcinoma in situ, 2 years since last therapy).
- •Diseases affecting the calcium homeostasis including thyroid diseases.
- •Coagulationsfactor PP <0,6
- •Regular use of medicine affecting the calciumhomeostasis; including diuretics, fenemal, lithium, antiepileptica.
- •SSRI-product with fluvoxamin
- •Treatment with hypnoticas
- •Treatment with beta-blocks
- •Ongoing treatment with melatonin
- •Continuously treatment with rifampicin
- •Severe malabsorption syndrome including gastric or intestinal resection.
- •Alcohol or drug abuse.
- •Major medical or social problems that will be likely to preclude participation for 3 months.
研究者
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