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    Clinical Trial Results:
    The effects of melatonin treatment on bone, marrow, sleep and arterial stiffness in postmenopausal women

    Summary
    EudraCT number
    		 2020-002934-34
    Trial protocol
    		 DK  
    Global end of trial date
    01 Feb 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 May 2023
    First version publication date
    24 May 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2020-AKA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04864509
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark, 8200
    Public contact
    Klinik for knogleskørhed, Anne Kristine Amstrup, anneamst@rm.dk
    Scientific contact
    Klinik for knogleskørhed, Anne Kristine Amstrup, anneamst@rm.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
    01 Feb 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Feb 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Feb 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Changes in gene expression in mesenchymal stem cells
    Protection of trial subjects
    At every visit the participants were asked whether or not they had experienced adverse event to the treatment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 May 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 41
    Worldwide total number of subjects
    41
    EEA total number of subjects
    41
    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)
    22
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were invited by letter. Recruitment period was from May to September 2021

    Pre-assignment
    Screening details
    		 Participants responding positively to the invitation received a questionnaire regarding exclusion criteria. Those who did not fulfill the exclusions criteria received further information about the study. They were further invited to an interview at the study place.

    Period 1
    Period 1 title
    Overall period trial
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Subject
    Blinding implementation details
    Glostrup Pharmacy randomized the participants (using a computer) into blocks of 2,4, and 8 participants. The block-sizes were unknown to the investigators. The participants as well as the investigators were blinded to the study drug allocation

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Melatonin
    Arm description
    		 Nightly dose og 10mg melatonin
    Arm type
    		 Active comparator

    Investigational medicinal product name
    melatonin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg nightly

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg nightly

    Number of subjects in period 1
    		Melatonin Placebo
    Started
    21
    20
    Completed
    19
    20
    Not completed
    2
    0
         Adverse event, non-fatal
    1
    -
         Illness in the nearby family
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall period trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall period trial Total
    Number of subjects
    		 41 41
    Age categorical
    Mean age
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    melatonin group: 63 (56-74) placebo group: 64 (55-75)
    Units: years
        arithmetic mean (inter-quartile range (Q1-Q3))
    		 64 (55 to 74) -
    Gender categorical
    Postmenopausal women
    Units: Subjects
        Female
    		 41 41
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Melatonin
    Reporting group description
    		 Nightly dose og 10mg melatonin

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Primary: Changes in mesenchymal stem cells

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    End point title
    		 Changes in mesenchymal stem cells
    End point description
    data still being analyzed
    End point type
    Primary
    End point timeframe
    Changes after three months of treatment
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    13
    16
    Units: percent
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 0)
    Statistical analysis title
    		 T-test
    Comparison groups
    Melatonin v Placebo
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Median difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: Changes in 24H blood pressure

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    End point title
    		 Changes in 24H blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    Changes before and after three months of treatment
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    19
    19
    Units: percent
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Changes in arterial stiffness

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    End point title
    		 Changes in arterial stiffness
    End point description
    data still being analyzed
    End point type
    Secondary
    End point timeframe
    Changes before and after three months of treatment
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    19
    19
    Units: percent
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: changes in biochemical parametres

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    End point title
    		 changes in biochemical parametres
    End point description
    data still being analyzed
    End point type
    Secondary
    End point timeframe
    Changes before and after three months of treatment
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    19
    20
    Units: Percent
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Changes in BMD

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    End point title
    		 Changes in BMD
    End point description
    Data still being analyzed
    End point type
    Secondary
    End point timeframe
    Changes before and after three months of treatment
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    19
    20
    Units: percent
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Changes in quality of sleep

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    End point title
    		 Changes in quality of sleep
    End point description
    data still being analyzed
    End point type
    Secondary
    End point timeframe
    Changes before and after three months of treatment
    End point values
    		 Melatonin Placebo
    Number of subjects analysed
    19
    20
    Units: percent
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Period of reporting: june 2021- febuary 2022
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    x
    Reporting groups
    Reporting group title
    Melatonin
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Melatonin Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 20 (5.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Transient Cerebral ischaemia
    Additional description: Hospitalized. Suspected of TCI. Previous history with TCIs
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Broken arm
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Melatonin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 21 (19.05%)
    2 / 20 (10.00%)
    General disorders and administration site conditions
    Headache
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    diarrhea
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    sore throat
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    COVID-19
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0

    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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