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    Clinical Trial Results:
    Treatment of osteopenia with melatonin: Effects on BMD, muscle strength and quality of life

    Summary
    EudraCT number
    		 2011-004670-28
    Trial protocol
    		 DK  
    Global end of trial date
    17 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Aug 2017
    First version publication date
    30 Aug 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2011-AKA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01690000
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus Universitetshospital, MEA
    Sponsor organisation address
    Tage-Hansens Gade 2, Aarhus C, Denmark, 8000
    Public contact
    Osteoporoseklinikken, Osteoporoseklinikken, 0045 7846 7681 , annekristineamstrup@gmail.dk
    Scientific contact
    Osteoporoseklinikken, Osteoporoseklinikken, 0045 7846 7681 , annekristineamstrup@gmail.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    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.
    Protection of trial subjects
    Clinical visits Blood analysis Muscle function test Balance function test
    Background therapy
    		 Calcium and Vitamin D supplementation
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Nov 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 81
    Worldwide total number of subjects
    81
    EEA total number of subjects
    81
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    40
    From 65 to 84 years
    41
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment from November 2012 to April 2013 Active Comparator: 1 mg melatonin nightly Intervention: Drug: Melatonin Active Comparator: 3 mg melatonin given nightly Intervention: Drug: Melatonin Active Comparator: Placebo Identical placebo given nightly

    Pre-assignment
    Screening details
    		 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

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    A restricted block randomization was performed. Groups of eight individuals were included in the blocks. Four participants were randomly allocated to placebo, while two others received 1 mg of melatonin, and 2 received 3 mg of melatonin

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Melatonin 1+3
    Arm description
    		 1 mg melatonin or 3 mg of melatonin nightly Intervention: Drug: Melatonin
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Melatonin 1 mg og 3 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1mg or 3mg administrated nightly

    Arm title
    		 Placebo
    Arm description
    		 Identical placebo given nightly
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Given nightly

    Number of subjects in period 1
    		Melatonin 1+3 Placebo
    Started
    40
    41
    Completed
    37
    35
    Not completed
    3
    6
         Adverse event, non-fatal
    2
    1
         Protocol deviation
    1
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Melatonin 1+3
    Reporting group description
    		 1 mg melatonin or 3 mg of melatonin nightly Intervention: Drug: Melatonin

    Reporting group title
    Placebo
    Reporting group description
    		 Identical placebo given nightly

    Reporting group values
    		 Melatonin 1+3 Placebo Total
    Number of subjects
    		 40 41 81
    Age categorical
    Women between 55-75
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 32 29 61
        From 65-84 years
    		 8 12 20
        85 years and over
    		 0 0 0
    Age continuous
    Women between 55-75 years
    Units: years
        arithmetic mean (standard deviation)
    		 62.9 ± 4.5 62.4 ± 3.5 -
    Gender categorical
    Only women could participate
    Units: Subjects
        Female
    		 40 41 81
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Melatonin 1+3
    Reporting group description
    		 1 mg melatonin or 3 mg of melatonin nightly Intervention: Drug: Melatonin

    Reporting group title
    Placebo
    Reporting group description
    		 Identical placebo given nightly

    Primary: Changes in BMD

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    End point title
    		 Changes in BMD
    End point description
    End point type
    Primary
    End point timeframe
    After 12 months treatment -end of study
    End point values
    		 Melatonin 1+3 Placebo
    Number of subjects analysed
    39
    37
    Units: Percent
    39
    37
    Statistical analysis title
    		 T-test
    Comparison groups
    Melatonin 1+3 v Placebo
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 2.7

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    2012 to 2014
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Melatonin 1+3
    Reporting group description
    		 Receiving either 1 or 3 mg melatonin

    Reporting group title
    Placebo
    Reporting group description
    		 Received placebo nightly

    Serious adverse events
    		 Melatonin 1+3 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 40 (12.50%)
    7 / 41 (17.07%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer surgery
         subjects affected / exposed
    0 / 40 (0.00%)
    3 / 41 (7.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Venous trombosis
    Additional description: Thrombosis after knee surgery
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Operation
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Arrhythmia
    Additional description: arrhythmia
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 41 (4.88%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Planned Operation
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Melatonin 1+3 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 40 (47.50%)
    19 / 41 (46.34%)
    Cardiac disorders
    Tachycardia
    Additional description: tachycardia
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 41 (2.44%)
         occurrences all number
    1
    1
    Ear and labyrinth disorders
    Dizziness
    Additional description: and headache
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 41 (2.44%)
         occurrences all number
    2
    1
    Immune system disorders
    Allergy
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    Social circumstances
    Abnormal dreams
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    others
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    airway infection
         subjects affected / exposed
    2 / 40 (5.00%)
    3 / 41 (7.32%)
         occurrences all number
    2
    3
    Cough
    Additional description: cough
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Skin discomfort
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    urigenital matters
         subjects affected / exposed
    1 / 40 (2.50%)
    3 / 41 (7.32%)
         occurrences all number
    1
    3
    Musculoskeletal and connective tissue disorders
    Pain
         subjects affected / exposed
    5 / 40 (12.50%)
    6 / 41 (14.63%)
         occurrences all number
    5
    6
    Infections and infestations
    Infection
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 41 (2.44%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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