OsteoporosisMelaOstNCT01690000
Treatment of Osteopenia With Melatonin
A study testing Melatonin in people with Osteoporosis, run by University of Aarhus at 1 site in Denmark.
Trial summary
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. 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
- What is being tested?
- Melatonin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Osteoporoseklinikken, dept of Endocrinology and Internal Medicine (MEA)
Aarhus C, 8000
About this study
Official title: Treatment of Osteopenia With Melatonin: Effects on BMD, Muscle Strength and Quality of Life
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.
Read the detailed description
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.
- Conditions
- Osteoporosis
- Being tested
- Melatonin
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
1 or 3 mg of melatonin PO each night for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Melatonin1 | Active comparator | 1 mg melatonin nightly Receives: Drug: Melatonin |
| Melatonin3 | Active comparator | 3 mg melatonin given nightly Receives: Drug: Melatonin |
| Placebo | Active comparator | Identical placebo given nightly Receives: Drug: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Bone Mineral Density (BMD)
Effects of melatonin on BMD will be assessed through DXA-scans
Measured: baseline and end of study (after 12 months)
Secondary outcomes (1)
Changes in Calcium Homeostasis
Calcium homeostasis will be analyzed through blood and urines samples
Measured: baseline, after 3, 6, 9 months, and end of study (after 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Kristine Amstrup, MD, Principal investigator, Osteoporoseklinikken, Dept. of Endocrinology and Internal Medicine (MEA) Aarhus University Hospital, Tage-Hansens Gade 2, AArhus, DEnmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690000
- Sponsor's protocol ID
- 2011-AKA
- Acronym
- MelaOst
- Status last verified
- Apr 2013
- First submitted
- 28 Jun 2012
- Last updated
- 6 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Amstrup AK, Sikjaer T, Mosekilde L, Rejnmark L. The effect of melatonin treatment on postural stability, muscle strength, and quality of life and sleep in postmenopausal women: a randomized controlled trial. Nutr J. 2015 Sep 30;14:102. doi: 10.1186/s12937-015-0093-1.
PubMed 26424587
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Osteopenia With Melatonin: Effects on BMD, Muscle Strength and Quality of Life
- ClinicalTrials.gov ID
- NCT01690000
- Acronym / sponsor ID
- MelaOst / 2011-AKA
- Conditions
- Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Posted 6 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Melatonin1 | Active comparator | Drug: Melatonin1 mg melatonin nightly |
| Melatonin3 | Active comparator | Drug: Melatonin3 mg melatonin given nightly |
| Placebo | Active comparator | Drug: MelatoninIdentical placebo given nightly |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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).
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 |
|---|---|---|
| Melatonin1 or 3 mg of melatonin PO each night for 12 months | Drug | Melatonin1, Melatonin3, Placebo |
Primary outcome
Changes in Bone Mineral Density (BMD)
Time frame: baseline and end of study (after 12 months)
Effects of melatonin on BMD will be assessed through DXA-scans
1 secondary outcome
Changes in Calcium Homeostasis
Time frame: baseline, after 3, 6, 9 months, and end of study (after 12 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26424587Amstrup AK, Sikjaer T, Mosekilde L, Rejnmark L. The effect of melatonin treatment on postural stability, muscle strength, and quality of life and sleep in postmenopausal women: a randomized controlled trial. Nutr J. 2015 Sep 30;14:102. doi: 10.1186/s12937-015-0093-1.
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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, MD principal investigator
Osteoporoseklinikken, Dept. of Endocrinology and Internal Medicine (MEA) Aarhus University Hospital, Tage-Hansens Gade 2, AArhus, DEnmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin in people with Osteoporosis, run by University of Aarhus at 1 site in Denmark.
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 3 inclusion and 14 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: finished, as of the sponsor's last update on 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Bone Mineral Density (BMD) (time frame: baseline and end of study (after 12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01690000, which also lists 1 linked publication.
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 6 May 2016.