Osteoporosis, PostmenopausalPhase 4NCT04864509
The Effects of Melatonin Treatment on Bone, Marrow, Sleep and Blood Pressure
A Phase 4 study testing Melatonin 10 MG in people with Osteoporosis, Postmenopausal, run by University of Aarhus.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- Melatonin 10 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 1 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Post-menopausal women between 55 and 75 years
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effects of Melatonin Treatment on Bone, Marrow, Sleep and Blood Pressure in Post Menopausal Women
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.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- Melatonin 10 MG, Placebo
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 10 MGDrug
Nightly dose
PlaceboDrug
Nightly dose
| Study group | Role | What they receive |
|---|---|---|
| Melatonin 10mg | Active comparator | Nightly oral dose Receives: Drug: Melatonin 10 MG |
| Placebo | Placebo comparator | nightly oral dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After study completion. Up to one year
Secondary outcomes (3)
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
Measured: 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.
Measured: After study completion. Up to one year
Cardiovascular health
Changes in 24h blood pressure and arterial stiffness measured by standardized equipment
Measured: After study completion. Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Kristine Amstrup, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864509
- Sponsor's protocol ID
- 2020-AKA
- Status last verified
- Jun 2020
- First submitted
- 12 Aug 2020
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Melatonin Treatment on Bone, Marrow, Sleep and Blood Pressure in Post Menopausal Women
- ClinicalTrials.gov ID
- NCT04864509
- Acronym / sponsor ID
- 2020-AKA
- Conditions
- Osteoporosis, Postmenopausal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin 10mg | Active comparator | Drug: Melatonin 10 MGNightly oral dose |
| Placebo | Placebo comparator | Drug: Placebonightly oral dose |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Post-menopausal women between 55 and 75 years
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 10 MGNightly dose | Drug | Melatonin 10mg |
| PlaceboNightly dose | Drug | Placebo |
Primary outcome
Gene expression
Time frame: 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.
3 secondary outcomes
Biochemical markers
Time frame: After study completion. Up to one year
Quality of sleep
Time frame: After study completion. Up to one year
Cardiovascular health
Time frame: After study completion. Up to one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Kristine Amstrup principal investigator
Aarhus University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Melatonin 10 MG in people with Osteoporosis, Postmenopausal, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Kristine Amstrup (78 45 54 75, anneamst@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression (time frame: After study completion. Up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.