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    Clinical Trial Results:
    The Additive effect of Vitamin K Supplementation and Bisphosphonate on Fracture Risk in Post-menopausal Osteoporosis

    Summary
    EudraCT number
    		 2010-022587-12
    Trial protocol
    		 GB  
    Global end of trial date
    12 Aug 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Aug 2026
    First version publication date
    08 Aug 2026
    Other versions
    Summary report(s)
    		 Vit K in osteoporosis EudraCT CSR Upload

    Trial information

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    Trial identification
    Sponsor protocol code
    VitK
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01232647
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Guy's and St Thomas' NHS Foundation Trust
    Sponsor organisation address
    Great Maze Pond, London, United Kingdom, SE19RT
    Public contact
    Geeta Hampson, King's Health Partners Clinical Trials Office, +44 0207188 1284, geeta.hampson@gstt.nhs.uk
    Scientific contact
    Geeta Hampson, King's Health Partners Clinical Trials Office, +44 0207188 1284, geeta.hampson@gstt.nhs.uk
    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
    12 Aug 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Aug 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Aug 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess whether treatment with bisphosphonates combined with vitamin K, in vitamin K deplete elderly women with osteoporosis, will offer additional benefit on skeletal metabolism and reduction of fracture risk.
    Protection of trial subjects
    To ensure the safety and well being of the study participants, all subjects will have a full medical history and clinical examination at the screening visit to ensure that there are no contra-indications as listed in the exclusion criteria. The subjects who will be eligible to take part in the vitamin K1 and K2 intervention study will be monitored at regular intervals where Side-effects and adverse events will be recorded and study subjects will be withdrawn from the study if they or the investigators have safety and/or tolerability concerns Routine safety blood tests (FBC, renal, liver and bone profile, PTH, vitamin D will be done at screening/baseline and at 18 months as detailed in the study protocol Adverse events and reaction reporting will start from baseline visit and will continue until the final visit at 18 months. If a participant withdraws from trial medication, adverse events and reactions will be reported until 1 month after the last dose of IMP.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 2015
    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
    United Kingdom: 105
    Worldwide total number of subjects
    105
    EEA total number of subjects
    105
    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)
    38
    From 65 to 84 years
    67
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 105
    Number of subjects completed
    		 105

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A: Conventional treatment plus placebo
    Arm description
    		 Weekly oral bisphosphonate (commonly Alendronate 70 mg weekly) and adjunctive calcium/vitamin D supplements (1.0g of calcium and 800 I.U of cholecalciferol). In addition, Group A (control group) will receive placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Bisphosphate + calcium/vitamin D supplements
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral bisphosphonate (commonly Alendronate 70 mg weekly) and adjunctive calcium/vitamin D supplements (1.0g of calcium and 800 I.U of cholecalciferol).

    Arm title
    		 Group B: Conventional treatment plus Vitamin K1 treatment (1 m
    Arm description
    		 Conventional treatment plus 1.0 mg daily of vitamin K1 and Vitamin K2 (MK4) placebo
    Arm type
    		 Experimental

    Investigational medicinal product name
    tOral bisphosphonate, adjunctive calcium/vitamin D supplement and vitamin K1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral bisphosphonate (commonly Alendronate 70 mg weekly) and adjunctive calcium/vitamin D supplements (1.0g of calcium and 800 I.U of cholecalciferol) plus 1.0 mg daily of vitamin K1

    Arm title
    		 Group C: Conventional treatment plus MK4 treatment (45 mg/day)
    Arm description
    		 Conventional treatment plus vitamin K2 (MK4) 45 mg daily and Vitamin K1 placebo
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oral bisphosphonate, adjunctive calcium/vitamin D supplements and MK4
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral bisphosphonate (commonly Alendronate 70 mg weekly) and adjunctive calcium/vitamin D supplements (1.0g of calcium and 800 I.U of cholecalciferol) plus vitamin K2 (MK4) 45 mg daily

    Number of subjects in period 1
    		Group A: Conventional treatment plus placebo Group B: Conventional treatment plus Vitamin K1 treatment (1 m Group C: Conventional treatment plus MK4 treatment (45 mg/day)
    Started
    35
    35
    35
    Completed
    35
    35
    35

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 105 105
    Age categorical
    Units: Subjects
        55-64
    		 38 38
        65-74
    		 53 53
        75-85
    		 14 14
    Gender categorical
    Units: Subjects
        Female
    		 105 105
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Group A: Conventional treatment plus placebo
    Reporting group description
    		 Weekly oral bisphosphonate (commonly Alendronate 70 mg weekly) and adjunctive calcium/vitamin D supplements (1.0g of calcium and 800 I.U of cholecalciferol). In addition, Group A (control group) will receive placebo.

    Reporting group title
    Group B: Conventional treatment plus Vitamin K1 treatment (1 m
    Reporting group description
    		 Conventional treatment plus 1.0 mg daily of vitamin K1 and Vitamin K2 (MK4) placebo

    Reporting group title
    Group C: Conventional treatment plus MK4 treatment (45 mg/day)
    Reporting group description
    		 Conventional treatment plus vitamin K2 (MK4) 45 mg daily and Vitamin K1 placebo

    Primary: BMD at Femoral Neck

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    End point title
    		 BMD at Femoral Neck [1]
    End point description
    End point type
    Primary
    End point timeframe
    18 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Please see uploaded report
    End point values
    		 Group A: Conventional treatment plus placebo Group B: Conventional treatment plus Vitamin K1 treatment (1 m Group C: Conventional treatment plus MK4 treatment (45 mg/day)
    Number of subjects analysed
    35
    35
    35
    Units: g/cm2
        arithmetic mean (confidence interval 95%)
    0.63 (0.60 to 0.66)
    0.61 (0.58 to 0.64)
    0.64 (0.60 to 0.67)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    18 months
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Active K1
    Reporting group description
    		 -

    Reporting group title
    Active K2
    Reporting group description
    		 -

    Reporting group title
    Placebo Group
    Reporting group description
    		 -

    Serious adverse events
    		 Active K1 Active K2 Placebo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 35 (11.43%)
    3 / 35 (8.57%)
    4 / 35 (11.43%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Cardiac disorders
    Oedema , cardiac failure and chest infection
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Pseudomeningocele
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Multiple small intraperitoneal nodules – admitted for biopsy
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Exacerbation of COPD
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Erythroderma
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Planned Surgery – arthroscopic arthrolysis of shoulder contracture
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neck of Femur (NOF) hip fracture
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Anaphylactic reaction to antibiotic
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inflammatory mass
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Active K1 Active K2 Placebo Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 35 (100.00%)
    35 / 35 (100.00%)
    35 / 35 (100.00%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    2
    0
    1
    Surgical and medical procedures
    Hip replacement
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    0 / 35 (0.00%)
         occurrences all number
    0
    2
    0
    Jaw Disc displacement with reduction (DDWR)
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Jaw pain
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    New dentures
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    1
    Low mood
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Immune system disorders
    Fever
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Hayfever
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    1
    Allergic reaction to insect bite
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Anaphylactic reaction to antibiotics
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    History of breast cancer
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Breast cancer
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Chest Infection
         subjects affected / exposed
    5 / 35 (14.29%)
    2 / 35 (5.71%)
    2 / 35 (5.71%)
         occurrences all number
    12
    2
    2
    Cough
         subjects affected / exposed
    4 / 35 (11.43%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    6
    0
    1
    Upper Respiratory Tract Infection
         subjects affected / exposed
    4 / 35 (11.43%)
    2 / 35 (5.71%)
    5 / 35 (14.29%)
         occurrences all number
    4
    2
    8
    Dyspnoea
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    0
    Asthma
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    1
    1
    0
    Emphysema
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Lung Shadow
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Chest tightness
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    0
    Investigations
    HIV exposure
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Chest pain
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Raised cholesterol
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Oedema
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Hypotension
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    1
    Atrial fibrillation
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    0 / 35 (0.00%)
         occurrences all number
    0
    2
    0
    Pulmonary vein
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Operation Aortic dilatation
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    4
    0
    2
    Headache
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 35 (5.71%)
    0 / 35 (0.00%)
         occurrences all number
    4
    2
    0
    Balance disorder
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    0
    2
    Syncope
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    1
    1
    0
    Occipital neuralgia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Neuropathic pain
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Numbness of tongue
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    1
    Numbness of foot
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Numbness of legs
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    1
    0
    2
    Bruising Chronic
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    1 / 35 (2.86%)
         occurrences all number
    0
    2
    1
    myelomonocytic leukemia (CMML-0)
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    Sore throat
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 35 (2.86%)
    1 / 35 (2.86%)
         occurrences all number
    3
    1
    2
    Husky voice
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal obstruction
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    1
    Eye disorders
    Vision disturbance
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    1
    Eye capsulotomy
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Cataract extraction
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    0 / 35 (0.00%)
         occurrences all number
    0
    2
    0
    Cellulitis around eye
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Swollen eyes
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Eye floaters
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Shafer's sign
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 35 (0.00%)
    3 / 35 (8.57%)
    1 / 35 (2.86%)
         occurrences all number
    0
    3
    1
    Reflux disease
         subjects affected / exposed
    2 / 35 (5.71%)
    2 / 35 (5.71%)
    2 / 35 (5.71%)
         occurrences all number
    2
    2
    2
    Vomiting
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    1
    0
    2
    Stomach upset
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    0
    Abdominal pain
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    1
    1
    0
    Diverticular disease
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    0
    2
    Weight loss
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    0
    2
    Stomach pain
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Hiatus hernia
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Stomach cramps
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Change in bowel habits
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    2 / 35 (5.71%)
         occurrences all number
    0
    2
    2
    Poor appetite
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Loose stools
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Intraperitoneal nodules
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Colonoscopy (routine screening)
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Blood in stools
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Bloating
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Constipation
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Cellulitis
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 35 (2.86%)
    1 / 35 (2.86%)
         occurrences all number
    1
    1
    1
    Bowen’s disease
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Basal cell carcinoma (excision)
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Excision of mole
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Actinic keratosis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Skin bruise on shin
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Itching from Insect bite
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Anal polyp
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    1
    Haemorrhoids
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Urinary Tract Infection
         subjects affected / exposed
    0 / 35 (0.00%)
    3 / 35 (8.57%)
    2 / 35 (5.71%)
         occurrences all number
    0
    3
    3
    Haematuria
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Ureteropelvic junction (UPJ) obstruction
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Dark Urine
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Shoulder pain
         subjects affected / exposed
    4 / 35 (11.43%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    4
    0
    0
    Foot injury
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Trigger finger
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    1
    1
    0
    Swollen hand
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Arm pain
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    3
    0
    0
    Peripheral fracture
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 35 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    2
    0
    2
    Foot pain
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Knee pain
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    2
    0
    1
    Swollen ankle
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    1
    Trapped nerve
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Leg pain
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    1
    Shoulder Injury
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Finger pain
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Old vertebral fracture
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    3
    0
    0
    Disc disease
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Spine osteoarthritis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Baker's cyst
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Wrist fracture
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 35 (2.86%)
    1 / 35 (2.86%)
         occurrences all number
    1
    1
    2
    Injury from an assault
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Cervical nerve compression
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Knee injury
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    3
    0
    1
    Hand osteoarthritis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Shoulder osteoarthritis
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    0 / 35 (0.00%)
         occurrences all number
    0
    2
    0
    Knee osteoarthritis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Back pain
         subjects affected / exposed
    0 / 35 (0.00%)
    4 / 35 (11.43%)
    1 / 35 (2.86%)
         occurrences all number
    0
    4
    1
    Thigh pain
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Wrist pain
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Foot tendon injury
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Hip fracture
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    1
    Shoulder contracture
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Arm and leg pain
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    Ankle tendon injury
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Back injury
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Rib fracture
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    1
    Rib injury
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Vertebral fracture
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Shoulder replacement
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Pilonidal abscess
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    3
    0
    Sepsis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Shoulder abscess
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Cold feeling
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Oct 2015
    SA1 - Protocol Version 4.0 16Jul15
    20 Oct 2015
    SA2 - IMPD Version 3.0 13Oct2015
    31 Mar 2016
    SA3 - Protocol Version 5.0 7Mar16, IMPD version 4.0 18Feb16
    19 Sep 2017
    SA4 -Shelf life extension of the IMP
    01 Aug 2018
    SA5 - Protocol Version 6.0 13Jul18
    28 Jul 2020
    SA6 - Protocol Version 7.0 27Jan20

    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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