Treatment of Osteopenia With Melatonin

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Treatment of Osteopenia With Melatonin: Effects on BMD, Muscle Strength and Quality of Life

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Melatonin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Melatonin1<br>1 mg melatonin nightly | Drug: Melatonin<br>* 1 or 3 mg of melatonin PO each night for 12 months<br>|
| Active Comparator: Melatonin3<br>3 mg melatonin given nightly | Drug: Melatonin<br>* 1 or 3 mg of melatonin PO each night for 12 months<br>|
| Active Comparator: Placebo<br>Identical placebo given nightly | Drug: Melatonin<br>* 1 or 3 mg of melatonin PO each night for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Bone Mineral Density (BMD) | Effects of melatonin on BMD will be assessed through DXA-scans | baseline and end of study (after 12 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Calcium Homeostasis | Calcium homeostasis will be analyzed through blood and urines samples | baseline, after 3, 6, 9 months, and end of study (after 12 months) |