Treatment of osteopenia with melatonin: Effects on bone mineral density, muscle strength, and quality of life

Conditions: Osteoporosis
MedDRA version: 14.1Level: PTClassification code 10031282Term: OsteoporosisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

Registration Number: EUCTR2011-004670-28-DK

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 80

Inclusion Criteria

•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

Exclusion Criteria

•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.
•Smokers
•Major medical or social problems that will be likely to preclude participation for one year.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the study is to assess the effect of melatonin treatment in patients with osteopenia on BMD, muscle function, quality of life and calcium homeostasis.;Secondary Objective: •BMD: Effects of treatment on BMD are determined by DXA-, QCT-, and pQCT-scans.<br>•Muscle- and balance function: Effects of treatment on muscle strength and balance function are determined using a dynamometer and a stadiometer (Meititur Ltd, Finland). <br>•Quality of life: Effect of treatment on indices of quality of life is assessed using the SF-36v2- and the WHO-Five Well-Being Index (WHO-5)-survey. Furthermore, quality of sleep (Pittsburgh Quality Sleep Index) and physical activity scale (PAS) is also assessed.<br>•Calcium homeostasis, bone metabolism, and body composition. Effects of treatment are assessed by measurements of calcitropic hormones, and biochemical markers of bone turnover. <br>;Primary end point(s): Increase in BMD ;Timepoint(s) of evaluation of this end point: End of year 2014

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Increase in quality of life, sleep pattern and physical activity level;Timepoint(s) of evaluation of this end point: End of year 2014