Back to resultsThe Effects of Melatonin Treatment on Bone, Marrow, Sleep and Blood Pressure
Primary Purpose
Osteoporosis, Postmenopausal
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Melatonin 10 MG
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis, Postmenopausal
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Melatonin 10mg
Placebo
Arm Description
Nightly oral dose
nightly oral dose
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
Cardiovascular health
Changes in 24h blood pressure and arterial stiffness measured by standardized equipment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04864509
Brief Title
The Effects of Melatonin Treatment on Bone, Marrow, Sleep and Blood Pressure
Official Title
The Effects of Melatonin Treatment on Bone, Marrow, Sleep and Blood Pressure in Post Menopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2021 (Anticipated)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double blinded
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Melatonin 10mg
Arm Type
Active Comparator
Arm Description
Nightly oral dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
nightly oral dose
Intervention Type
Drug
Intervention Name(s)
Melatonin 10 MG
Intervention Description
Nightly dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Nightly dose
Primary Outcome Measure Information:
Title
Gene expression
Description
Changes in gene expression in human mesenchymal stem cells.The biopsies are put on freeze after obtaining them. All biopsies are analysed at once.
Time Frame
After study completion. Up to one year
Secondary Outcome Measure Information:
Title
Biochemical markers
Description
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
Time Frame
After study completion. Up to one year
Title
Quality of sleep
Description
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.
Time Frame
After study completion. Up to one year
Title
Cardiovascular health
Description
Changes in 24h blood pressure and arterial stiffness measured by standardized equipment
Time Frame
After study completion. Up to one year
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
self-presentation
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Kristine Amstrup
Phone
78 45 54 75
Email
anneamst@rm.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Kristine Amstrup
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Effects of Melatonin Treatment on Bone, Marrow, Sleep and Blood Pressure
We'll reach out to this number within 24 hrs