Treatment of Osteopenia With Melatonin

University of Aarhus81 enrolled

Overview

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.

Background: Melatonin is known for its regulation of circadian rhythm. The production falls with age, which explains why elderly may have disturbed sleep patterns. Laboratory study and animal experimental studies suggests that melatonin also may protect against bone loss through increased osteoblast- and inhibited osteoclast activity. However, so far human studies have not been performed. Design and patients: Double blinded randomised controlled study. Eighty post-menopausal women (aged 55-75) with osteopenia are randomized to receive 1mg, 3mg or placebo (daily - at night time) for 12 months. Methods and results: Effects of melatonin on BMD, bone- structure and mass will be assessed through DXA-scans, pQCT, and QCT. Quality of life, sleep, and activity level will be assessed though questionnaires. Calcium homeostasis will be analyzed through blood and urines samples. As safety parameters, balance and muscle function will also be performed. Conclusion: Expected improvements in BMD, quality of life and sleep.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Osteoporosis

Interventions

MelatoninDRUG

1 or 3 mg of melatonin PO each night for 12 months

Eligibility

Sex: FEMALEMin age: 55 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Osteoporoseklinikken, dept of Endocrinology and Internal Medicine (MEA)

Aarhus C, Denmark

Outcomes

Primary Outcomes

Changes in Bone Mineral Density (BMD)

Effects of melatonin on BMD will be assessed through DXA-scans

Time frame: baseline and end of study (after 12 months)

Secondary Outcomes

Changes in Calcium Homeostasis

Calcium homeostasis will be analyzed through blood and urines samples

Time frame: baseline, after 3, 6, 9 months, and end of study (after 12 months)

Data from ClinicalTrials.gov

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