Treatment of osteopenia with melatonin: Effects on BMD, muscle strength and quality of life - MelaOst

Aarhus University Hospital, Dept of Endocrinology and Internel Medicine (MEA)0 个研究点目标入组 80 人开始时间: 2012年4月25日最近更新: 2016年1月11日

适应症

试验速览

暂无简介。

•Postmenopausal women between 55 and 75 years.
•Osteopeni verified by DXA-scans of total hip or lumbar spine (t-score between -1 and -2.5)
•Written informed consent after oral and written information
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•Severely impaired renal function (plasma creatinine >60 eGFR ml/l).
•Severely impaired hepatic function (Plasma alanine aminotransferase (ALAT) and/or alkaline phosphatase more the dobbed compared to upper limit of reference value).
•Coagulation factors PP <0.6
•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 untreated thyroid diseases.
•Regular use of medicine affecting the calciumhomeostasis; including diuretics, fenemal, lithium, antiepileptica, glucosteroids.
•SSRI-product with fluvoxamin.
•Treatment with carbamazepin
•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 one year.

发起方

Aarhus University Hospital, Dept of Endocrinology and Internel Medicine (MEA)