Osteoporosis, Postmenopausal
Conditions
Brief summary
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.
Interventions
DRUGMelatonin 10 MG
Nightly dose
DRUGPlacebo
Nightly dose
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double blinded
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gene expression | After study completion. Up to one year | Changes in gene expression in human mesenchymal stem cells.The biopsies are put on freeze after obtaining them. All biopsies are analysed at once. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical markers | After study completion. Up to one year | 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 |
| Quality of sleep | After study completion. Up to one year | 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. |
| Cardiovascular health | After study completion. Up to one year | Changes in 24h blood pressure and arterial stiffness measured by standardized equipment |
Contacts
Primary ContactAnne Kristine Amstrup
Outcome results
None listed