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    Clinical Trial Results:
    Denosumab in the prevention of immobilization-induced bone loss in Intensive Care Unit patients

    Summary
    EudraCT number
    		 2018-000552-18
    Trial protocol
    		 AT  
    Global end of trial date
    24 Mar 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Mar 2024
    First version publication date
    09 Mar 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1155/2018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Waehringer Guertel 18-20, Vienna, Austria, 1090
    Public contact
    Clincial Trial Information Desk, Medical University of Vienna, 0043 14040043330, pmr-office@meduniwien.ac.at
    Scientific contact
    Clincial Trial Information Desk, Medical University of Vienna, 0043 14040043330, pmr-office@meduniwien.ac.at
    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
    24 Mar 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Mar 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Mar 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    twofold: a) to evaluate if a single administration of denosumab decreases bone resorption (CTX-1) within one month in immobilized patients b) to evaluate if one year of denosumab therapy has a positive effect on the immobilization-associated bone loss. (hip region) Additionally, potential changes of BTMs will be evaluated. Pilot study (n=14): evaluate if a single administration of denosumab decreases bone resorption (CTX-1) within one month in immobilized patients
    Protection of trial subjects
    Trial subjects were protected by periodic follow up appointments after study inclusion.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Dec 2019
    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
    Austria: 14
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    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)
    12
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 patients with acute aSAH HH IV/V or ICH and severe neurological deficits, reduced state of consciousness, age 30-80, excl: intake of drugs with potential effects on BMD, fragility fracture within the previous six months, non-osteoporotic bone disease, severe renal insufficiency, malignant disease in the preceding five years, pregnancy, DM

    Period 1
    Period 1 title
    Baseline Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Denosumab
    Arm description
    		 Within 72 hours after ICU admission, they were randomized in a 1:1 ratio to receive denosumab 60 mg subcutaneously.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Denosumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Within 72 hours after ICU admission, they were randomized in a 1:1 ratio to receive denosumab 60 mg subcutaneously.

    Arm title
    		 Placebo
    Arm description
    		 Within 72 hours after ICU admission, they were randomized in a 1:1 ratio to receive placebo subcutaneously.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Within 72 hours after ICU admission, they were randomized in a 1:1 ratio to receive placebo subcutaneously.

    Number of subjects in period 1
    		Denosumab Placebo
    Started
    7
    7
    Completed
    7
    7

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Denosumab
    Reporting group description
    		 Within 72 hours after ICU admission, they were randomized in a 1:1 ratio to receive denosumab 60 mg subcutaneously.

    Reporting group title
    Placebo
    Reporting group description
    		 Within 72 hours after ICU admission, they were randomized in a 1:1 ratio to receive placebo subcutaneously.

    Primary: CTX 1

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    End point title
    		 CTX 1
    End point description
    End point type
    Primary
    End point timeframe
    The primary endpoint was group differences in the percentage change of C-terminal telopeptide of type 1 collagen (CTX-1) levels in serum from denosumab/placebo application to four weeks thereafter.
    End point values
    		 Denosumab Placebo
    Number of subjects analysed
    7
    7
    Units: ng/ml
        number (not applicable)
    7
    7
    Statistical analysis title
    		 Primary endpoint
    Statistical analysis description
    The pre-specified primary endpoint was the percentage change in serum levels of C-terminal telopeptide of type 1 collagen (CTX-1) from the time of denosumab/placebo application to four weeks thereafter.
    Comparison groups
    Denosumab v Placebo
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05 [1]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [1] - Statistical analysis was performed using SAS 9.4 based on a two-sided significance level of 5%.

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    6 months after study inclusion. No adverse events related to the study medication were observed during the first 4 weeks after application as well as during the follow-up period. Serum calcium levels remained within the normal range.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse events related to the study medication were observed during the first four weeks after application as well as during the follow-up period. Serum calcium levels remained within the normal range. One patient died within four weeks after aSAH due to fatal general brain edema based on previous vasospasm and cerebral infarction. The patient never received denosumab because she was in the placebo group.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/36056473
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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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