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    Clinical Trial Results:
    Preliminary effect and safety of physiotherapy with strength training and protein-dense nutritional supplement in combination with anabolic steroids in cross-continuum rehabilitation of patients with hip fracture - a randomized controlled pilot trial. (The HIP-SAP trial)

    Summary
    EudraCT number
    2017-001543-13
    Trial protocol
    DK  
    Global end of trial date
    03 Jun 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    03 Apr 2021
    First version publication date
    03 Apr 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HIP-SAP
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03545347
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Copenhagen University Hospital Amager-Hvidovre
    Sponsor organisation address
    Kettegård alle 30, Hvidovre, Denmark, 2650
    Public contact
    Morten Tange Kristensen, Amager-Hvidovre Hospital, 0045 38626191, morten.tange.kristensen@regionh.dk
    Scientific contact
    Morten Tange Kristensen, Amager-Hvidovre Hospital, 0045 38626191, morten.tange.kristensen@regionh.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 Oct 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Jun 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jun 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of this placebo controlled pilot trial is to determine the preliminary effect and safety of a 12 week multimodal intervention initiated during admission in the acute ward after hip fracture surgery. The intervention under investigation is a combination therapy consisting of physiotherapy (functional, balance and strength training), protein- dense nutritional supplement and nandrolone decanoate (Deca-Durabolin) supplement on improving the fractured limb knee-extension muscle strength at a 14 week follow-up.
    Protection of trial subjects
    The trial is conducted in accordance with the Helsinki declaration and have been approved by the Capital Region’s Research Ethics Committee (H-18004495)
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    14 May 2018
    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: 23
    Worldwide total number of subjects
    23
    EEA total number of subjects
    23
    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)
    1
    From 65 to 84 years
    20
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    Screening and inclusion from 6th of June 2018 until 24th February 2020.

    Pre-assignment
    Screening details
    717 patients were screened

    Period 1
    Period 1 title
    "overall trial" (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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Nandrolone
    Arm description
    Nandrolone decanoate (Deca-Durabolin 50mg/ml)
    Arm type
    Experimental

    Investigational medicinal product name
    Deca-Durabolin
    Investigational medicinal product code
    PR1in
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    5 injection over 12 weeks (3 weeks intervals). Women received 50 mg per dose; men with total testosterone ≥ 11 nmol/l received 100 mg, and men with total testosterone < 11 nmol/l received a dose of 200 mg per dose.

    Arm title
    Placebo
    Arm description
    Saline injection
    Arm type
    Placebo

    Investigational medicinal product name
    0.9% Sodium Chloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solvent for parenteral use
    Routes of administration
    Intramuscular use
    Dosage and administration details
    50 mg intramuscular injected

    Number of subjects in period 1
    Nandrolone Placebo
    Started
    12
    11
    Completed
    11
    10
    Not completed
    1
    1
         Consent withdrawn by subject
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nandrolone
    Reporting group description
    Nandrolone decanoate (Deca-Durabolin 50mg/ml)

    Reporting group title
    Placebo
    Reporting group description
    Saline injection

    Reporting group values
    Nandrolone Placebo Total
    Number of subjects
    12 11 23
    Age categorical
    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
    Units: years
        arithmetic mean (standard deviation)
    73.5 ( 5.9 ) 73.4 ( 7.7 ) -
    Gender categorical
    Units: Subjects
        Female
    9 9 18
        Male
    3 2 5
    Fracture type
    Units: Subjects
        Intracapsular
    9 7 16
        Extracapsular
    3 4 7
    Type of syrgery
    Units: Subjects
        2 pins
    0 1 1
        Hemi/total arthroplasty
    8 6 14
        Dynamic hip screw
    1 1 2
        Intramedular hip screw
    3 3 6
    Walking aid
    Units: Subjects
        Indoor walking aid
    0 1 1
        Outdoor walking aid
    2 2 4
        No walking aid
    10 8 18
    Discharged home
    Units: Subjects
        Discharged home
    11 10 21
        discharged to rehabilitation
    1 1 2
    New Mobility Score
    Units: points
        arithmetic mean (standard deviation)
    8.6 ( 0.8 ) 8.5 ( 1.0 ) -
    Length of stay
    Units: days
        median (inter-quartile range (Q1-Q3))
    8 (6 to 9) 8 (7 to 9) -
    American Society of anestesiologist GRADE (ASA)
    Units: point
        arithmetic mean (standard deviation)
    2.1 ( 0.7 ) 1.9 ( 0.3 ) -

    End points

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    End points reporting groups
    Reporting group title
    Nandrolone
    Reporting group description
    Nandrolone decanoate (Deca-Durabolin 50mg/ml)

    Reporting group title
    Placebo
    Reporting group description
    Saline injection

    Primary: Knee extension strength, non fractured leg

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    End point title
    Knee extension strength, non fractured leg
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to 14 weeks follow-up
    End point values
    Nandrolone Placebo
    Number of subjects analysed
    11
    10
    Units: Nm/kg
        arithmetic mean (confidence interval 95%)
    0.28 (0.20 to 0.37)
    0.13 (-0.07 to 0.32)
    Statistical analysis title
    within group difference
    Comparison groups
    Nandrolone v Placebo
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.05
    Method
    t-test, 2-sided
    Confidence interval

    Primary: Knee extension strength fractured leg

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    End point title
    Knee extension strength fractured leg
    End point description
    within group difference
    End point type
    Primary
    End point timeframe
    baseline to 14-week follow-up
    End point values
    Nandrolone Placebo
    Number of subjects analysed
    11
    10
    Units: Nm/kg
        arithmetic mean (confidence interval 95%)
    0.61 (0.34 to 0.88)
    0.50 (0.21 to 0.79)
    Statistical analysis title
    Within-group differences
    Comparison groups
    Nandrolone v Placebo
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.05
    Method
    t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    baseline until 16 weeks
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Nandrolone
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Serious adverse events
    Nandrolone Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 12 (25.00%)
    0 / 11 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Post procedural infection
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hip related pain
    Additional description: 24-hour hospital stay because of hip fracture-related pain, ex-ray showed slight compression of the fracture site as expected according to type of ostesynthesis.
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery stenosis
    Additional description: preexisting coronary stenosis, treated with stent
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (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
    Nandrolone Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 12 (100.00%)
    11 / 11 (100.00%)
    Injury, poisoning and procedural complications
    Falls
         subjects affected / exposed
    0 / 12 (0.00%)
    3 / 11 (27.27%)
         occurrences all number
    0
    3
    Cardiac disorders
    Syncope
    Additional description: Short fainting related mobilization
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Blood pressure abnormal
    Additional description: slight increase
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    click sounds osteosynthesis material
    Additional description: Stopped after 2 weeks
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    delayed fracture heeling
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    edema
    Additional description: primarily operated leg
         subjects affected / exposed
    3 / 12 (25.00%)
    0 / 11 (0.00%)
         occurrences all number
    3
    0
    Pain
    Additional description: Pain related to surgical procedure
         subjects affected / exposed
    0 / 12 (0.00%)
    5 / 11 (45.45%)
         occurrences all number
    0
    5
    Dizziness
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Weight decreased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    rash
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 12 (8.33%)
    3 / 11 (27.27%)
         occurrences all number
    1
    3
    Ulcer
    Additional description: history of previous ulcer
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    prostate-specific antigen increased
    Additional description: slight increase, 3 weeks after normalized
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Liver parameters increased
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 11 (18.18%)
         occurrences all number
    1
    2
    Skin and subcutaneous tissue disorders
    Quinkes edema
    Additional description: One episode, a pre-existing condition, and well treated.
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    chronic leg ulcer
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    pressure ulcer
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Greenish urine
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    Renal impairment
    Additional description: preexisting condition
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Depressed mood
    Additional description: Known condition prior to enrollment
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Endocrine disorders
    cholesterol parameters increased
         subjects affected / exposed
    3 / 12 (25.00%)
    2 / 11 (18.18%)
         occurrences all number
    3
    2
    increased sweating
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    Hirsutism
    Additional description: preexisting facial hirsutisme (upper lip) ferriman-gallwey score 1 incresed to slight at chin, still score 1.
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Libido increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Infections and infestations
    infection cicatrice
    Additional description: treated with antibiotics
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    Viral infection (common cold)
         subjects affected / exposed
    2 / 12 (16.67%)
    3 / 11 (27.27%)
         occurrences all number
    2
    3
    Herpes zoster cutaneous disseminated
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 11 (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
    For support, Contact us.
    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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