Treatment of Osteopenia With Melatonin

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Aarhus
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• Postmenopausal women between 55 and 75 years.

• Osteopenia 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

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 doubled 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 calcium homeostasis; including diuretics, 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.