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    Clinical Trial Results:
    The effect of effervescent and buffered alendronate on bone turnover compared to conventional alendronate: A randomized non-inferiority trial

    Summary
    EudraCT number
    		 2020-005040-35
    Trial protocol
    		 DK  
    Global end of trial date
    24 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jul 2023
    First version publication date
    05 Jul 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    0120
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05325515
    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
    Dept. of Endocrinology , Aarhus University Hospital, +45 78455470, torbhars@rm.dk
    Scientific contact
    Dept. of Endocrinology , Aarhus University Hospital, +45 78455470, torbhars@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 Dec 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Aug 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Aug 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate if Binosto decreases bone resorption to the same extent as Fosamax
    Protection of trial subjects
    The study was monitored by the GCP-unit at Aarhus University, Denmark
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 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: 64
    Worldwide total number of subjects
    64
    EEA total number of subjects
    64
    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)
    30
    From 65 to 84 years
    34
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were identified at the Osteoporosis Clinic, Aarhus University Hospital, Denmark. Postmenopausal women with BMD T-score were invited by letter for further participation.

    Pre-assignment
    Screening details
    		 We screened 96 individuals for inclusion. 2 of those withdrew consent and 30 were excluded due to exclusion criteria. Thus we ended up with 64 participants that we randomized 1:1.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Binosto
    Arm description
    		 Experimental treatment with effervescent and buffered alendronate
    Arm type
    		 Experimental

    Investigational medicinal product name
    Binosto
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Effervescent tablet
    Routes of administration
    Oral use
    Dosage and administration details
    70mg in one tablet weekly

    Arm title
    		 Fosamax
    Arm description
    		 Active comparator
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fosamax
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    70 mg in one tablet weekly

    Number of subjects in period 1
    		Binosto Fosamax
    Started
    32
    32
    Completed
    29
    27
    Not completed
    3
    5
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    1
    4
         Serious adverse event, unrelated
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Binosto
    Reporting group description
    		 Experimental treatment with effervescent and buffered alendronate

    Reporting group title
    Fosamax
    Reporting group description
    		 Active comparator

    Reporting group values
    		 Binosto Fosamax Total
    Number of subjects
    		 32 32 64
    Age categorical
    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)
    		 20 21 41
        From 65-84 years
    		 12 11 23
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.9 ± 6 61.8 ± 6.2 -
    Gender categorical
    Units: Subjects
        Female
    		 32 32 64
    Years since menopause
    Units: years
        arithmetic mean (standard deviation)
    		 11.9 ± 5.7 14.0 ± 6.2 -
    Lumbar spine T-score
    Units: None
        arithmetic mean (standard deviation)
    		 -1.9 ± 0.8 -1.7 ± 0.6 -
    Total hip T-score
    Units: None
        arithmetic mean (standard deviation)
    		 -1.5 ± 0.6 -1.4 ± 0.6 -
    Femoral neck T-score
    Units: None
        arithmetic mean (standard deviation)
    		 -1.8 ± 0.6 -1.8 ± 0.5 -
    CTx
    Units: microgram(s)/litre
        median (full range (min-max))
    		 0.6 (0.43 to 1.07) 0.6 (0.43 to 1.16) -

    End points

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    End points reporting groups
    Reporting group title
    Binosto
    Reporting group description
    		 Experimental treatment with effervescent and buffered alendronate

    Reporting group title
    Fosamax
    Reporting group description
    		 Active comparator

    Primary: Decrease in bone resorption

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    End point title
    		 Decrease in bone resorption
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to week 16
    End point values
    		 Binosto Fosamax
    Number of subjects analysed
    29
    27
    Units: percent
        arithmetic mean (standard deviation)
    -47 ± 23
    -58 ± 24
    Statistical analysis title
    		 Primary end point
    Statistical analysis description
    We analyzed if the decrease in bone resorption with Binosto was non-inferior to that with Fosamax
    Comparison groups
    Binosto v Fosamax
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.05
    Method
    		 Comparison of means and CIs
    Confidence interval
    Notes
    [1] - The non-inferiority test came out indeterminate

    Secondary: Decrease in bone formation

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    End point title
    		 Decrease in bone formation
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 16
    End point values
    		 Binosto Fosamax
    Number of subjects analysed
    29
    27
    Units: percent
        arithmetic mean (standard deviation)
    -35 ± 21
    -46 ± 23
    No statistical analyses for this end point

    Secondary: Persistence

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    End point title
    		 Persistence
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 16
    End point values
    		 Binosto Fosamax
    Number of subjects analysed
    29
    27
    Units: Percent
    100
    96
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to 16 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    aug 22
    Reporting groups
    Reporting group title
    BINOSTO
    Reporting group description
    		 -

    Reporting group title
    FOSAMAX
    Reporting group description
    		 -

    Serious adverse events
    		 BINOSTO FOSAMAX
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 32 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Reproductive system and breast disorders
    Breast cancer
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 32 (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: 1%
    Non-serious adverse events
    		 BINOSTO FOSAMAX
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 32 (56.25%)
    17 / 32 (53.13%)
    General disorders and administration site conditions
    Headache
         subjects affected / exposed
    2 / 32 (6.25%)
    3 / 32 (9.38%)
         occurrences all number
    2
    3
    Fracture
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 32 (3.13%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 32 (12.50%)
    3 / 32 (9.38%)
         occurrences all number
    4
    3
    Diarrhoea
         subjects affected / exposed
    9 / 32 (28.13%)
    5 / 32 (15.63%)
         occurrences all number
    9
    5
    Reflux gastritis
         subjects affected / exposed
    2 / 32 (6.25%)
    5 / 32 (15.63%)
         occurrences all number
    2
    5

    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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