The Effects of Melatonin Treatment on Bone, Marrow, Sleep and Blood Pressure

Study Overview
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Brief Summary
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Melatonin protects your bones while losing fat! This was previously demonstrated by our group. The mechanisms behind these findings are still elusive, and the aim of the present study is to assess the mechanisms. In a double-blinded randomized controlled trial 40 postmenopausal woman are randomized to receive either 10 mg melatonin or placebo nightly for three months. Changes in gene expression in marrow cells will be assessed through micro array. Markers of bone metabolism will be assessed through biochemical markers. Cardiovascular health will be measured by tonometry and 24h blood pressure. The results of the study will contribute with important knowledge about the beneficial effects of melatonin making it an interesting supplement to known treatment regimens against osteoporosis and overweight.

Official Title
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The Effects of Melatonin Treatment on Bone, Marrow, Sleep and Blood Pressure in Post Menopausal Women

Conditions
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Osteoporosis, Postmenopausal

Intervention / Treatment
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* Drug: Melatonin 10 MG
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-menopausal women between 55 and 75 years Exclusion Criteria: Severely impaired renal function Severely impaired hepatic function 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, fenemal, lithium, antiepileptica and glucosteroids Selective serotonin reuptake inhibitor (SSRI)-products with fluvoxamin Treatment with carbamazepin Treatment with rifampicin Severe malabsorption syndrome including gastric or intestinal resection Alcohol or drug abuse Smokers

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: Melatonin 10mg<br>Nightly oral dose | Drug: Melatonin 10 MG<br>* Nightly dose<br>|
| Placebo Comparator: Placebo<br>nightly oral dose | Drug: Placebo<br>* Nightly dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression | Changes in gene expression in human mesenchymal stem cells.The biopsies are put on freeze after obtaining them. All biopsies are analysed at once. | After study completion. Up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical markers | Changes in biochemical markers of bone metabolism measured in blood: Markers include PTH (pmol/l), ionized calcium (mmol/l) CTX (ug/l). Although different units they all contribute to the overall evaluation of bone metabolism and must therefore be regarded as the same outcome measure | After study completion. Up to one year | 
| Quality of sleep | Assessed through the questionnaire Pittsburgh quality of sleep questionnaire. A validated questionnaire assessing the quality of sleep. A score between 0-5 indicates a good quality of sleep. Scores above 5 indicate a poor quality of sleep. | After study completion. Up to one year | 
| Cardiovascular health | Changes in 24h blood pressure and arterial stiffness measured by standardized equipment | After study completion. Up to one year |