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    Clinical Trial Results:
    Effect of active vitamin D treatment on arterial stiffness and albuminuria in patients with type 2 diabetes and stage 3 chronic kidney disease

    Summary
    EudraCT number
    2010-018285-23
    Trial protocol
    GB  
    Global end of trial date
    01 Apr 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    02 Jun 2019
    First version publication date
    02 Jun 2019
    Other versions
    Summary report(s)
    Summary report

    Trial information

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    Trial identification
    Sponsor protocol code
    18102009
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    King's College London
    Sponsor organisation address
    The Strand, London, United Kingdom, WC2R 2LS
    Public contact
    Diabetes Research, King's College London, 0044 02078484413, luigi.gnudi@kcl.ac.uk
    Scientific contact
    Diabetes Research, King's College London, 0044 02078484413, luigi.gnudi@kcl.ac.uk
    Sponsor organisation name
    Guy's and St Thomas' NHS Foundation Trust
    Sponsor organisation address
    Great Maze Pond, London, United Kingdom, SE19RT
    Public contact
    Dr Luigi Gnudi, Guy's and St Thomas' NHS Foundation Trust, 0044 02078484413, luigi.gnudi@kcl.ac.uk
    Scientific contact
    Dr Luigi Gnudi, Guy's and St Thomas' NHS Foundation Trust, 0044 02078484413, luigi.gnudi@kcl.ac.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
    01 Apr 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Apr 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Apr 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main research question is to evaluate the effect of Calcitriol treatment as compared to placebo on arterial stiffness in patients with type 2 diabetes and chronic kidney disease. Arterial stiffness is a marker and predictor of cardiovascular disease risk. Arterial stiffness will be assessed by aortic pulse wave velocity (Ao-PWV) which is a measure of arterial stiffness. Ao-PWV measures the the speed of transmission of the pulse wave along the aorta the largest blood vessel in the body. The greater the speed the greater the arterial stiffness. Interventions that recuce arterial stiffness may prevent cardiovascular disease. Currently it is not known if treatment with Calcitriol can affect arterial stiffness in patients with diabetes and kidney disease. We wish to study the effect of Calcitriol or placebo as add on treatment to existing medical treatments on arterial stiffness in a placebo controlled double blind study. Patients will continue with other medical treatments for their
    Protection of trial subjects
    Subjects will be provided with a Patient Information Sheet (PIS) and time to consider the contents of this document. They will have the opportunity to discuss alternative treatment options and possible enrolment in the study with the Investigator, prior to providing written informed consent.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    11 Oct 2010
    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: 140
    Worldwide total number of subjects
    140
    EEA total number of subjects
    140
    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)
    55
    From 65 to 84 years
    85
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Patients will be recruited from outpatient clinics at Guy’s and St Thomas Hospital. Patients referred from primary care or other regional hospitals will be reviewed in the above clinics and recruited if suitable.

    Pre-assignment
    Screening details
    Patients were eligible to participate if they were diagnosed with Type 2 diabetes and had stage 3 chronic kidney disease.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Calcitriol
    Arm description
    0.25 mcg od of calcitriol for 48 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Rocaltrol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0.25 µg microgram(s) per day

    Arm title
    Placebo
    Arm description
    Placebo for 48 weeks
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 capsule per day

    Number of subjects in period 1
    Calcitriol Placebo
    Started
    72
    68
    Completed
    64
    63
    Not completed
    8
    5
         Bereavement
    1
    -
         Adverse event, serious fatal
    1
    -
         Adverse event, non-fatal
    1
    2
         Consent withdrawn by subject
    2
    1
         Lost to follow-up
    3
    2

    Baseline characteristics

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

    Reporting group values
    Overall Trial Period Total
    Number of subjects
    140 140
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    55 55
        From 65-84 years
    85 85
    Gender categorical
    Units: Subjects
        Female
    40 40
        Male
    100 100

    End points

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    End points reporting groups
    Reporting group title
    Calcitriol
    Reporting group description
    0.25 mcg od of calcitriol for 48 weeks.

    Reporting group title
    Placebo
    Reporting group description
    Placebo for 48 weeks

    Primary: Change in pulse wave velocity

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    End point title
    Change in pulse wave velocity [1]
    End point description
    End point type
    Primary
    End point timeframe
    The mean change from baseline to endpoint. Endpoint will be defined as the last available post-baseline measurement up to and including 48 weeks post randomisation.
    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 attached summary results.
    End point values
    Calcitriol Placebo
    Number of subjects analysed
    64
    63
    Units: m/s
        arithmetic mean (full range (min-max))
    0.05 (-0.68 to 0.78)
    0.23 (-0.46 to 0.93)
    Attachments
    Summary Report
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were recorded from 2 weeks prior to randomisation to 60 weeks post randomisation
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    CALCITRIOL GROUP
    Reporting group description
    Subjects randomised to receive calcitriol

    Reporting group title
    PLACEBO GROUP
    Reporting group description
    -

    Serious adverse events
    CALCITRIOL GROUP PLACEBO GROUP
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 64 (15.63%)
    20 / 63 (31.75%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    1
    1
    Vascular disorders
    Inferior cerebellar infarction
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute infarction of right hemi-pons
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute left anterothalamic infarct
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral vascular accident
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 63 (3.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic stenosis
    Additional description: Collapse due to aortic stenosis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular thrombosis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ischaemic heart disease
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 63 (3.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical chest pain
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid retention
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shortness of breath with chest pain
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchogenic cyst
    Additional description: Collapse due to bronchogenic cyst
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumococcal infection
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Loss of consciousness
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Hyponatraemia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Otitis externa
    Additional description: Left necrotising externa
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gall stones
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision hernia
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic bowel
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hyperkalaemia
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 63 (3.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Foot infection
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    removal of basal cell carcinoma
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blister
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot ulcer
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes simplex virus
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
    Additional description: Right foot, debridement of 5th toe
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Right breast infection
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (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
    CALCITRIOL GROUP PLACEBO GROUP
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 64 (73.44%)
    45 / 63 (71.43%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Syncope
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Cataract operation
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences all number
    1
    2
    Vitrectomy
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Tooth extraction
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences all number
    1
    1
    Immune system disorders
    Gout
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences all number
    1
    1
    Hayfever
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 63 (0.00%)
         occurrences all number
    2
    0
    Insect bite
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Nasal congestion
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Cardiac disorders
    Swelling
         subjects affected / exposed
    2 / 64 (3.13%)
    4 / 63 (6.35%)
         occurrences all number
    2
    4
    Atrial fibrillation
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    bilateral peripheral oedema
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Burning sensation
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Palpitations
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Hypotension
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 63 (0.00%)
         occurrences all number
    2
    0
    Oedema
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    2
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences all number
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Bronchitis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    5 / 64 (7.81%)
    4 / 63 (6.35%)
         occurrences all number
    7
    4
    Shortness of breath
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 63 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Bell's phenomenon
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Loss of consciousness
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Dizziness
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Faint
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Shaking legs
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 63 (3.17%)
         occurrences all number
    0
    2
    Headache
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Colour vision disturbance
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Laser therapy
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Photocoagulation
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Dizzy spells
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    2 / 64 (3.13%)
    2 / 63 (3.17%)
         occurrences all number
    2
    2
    Vomiting
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 63 (0.00%)
         occurrences all number
    2
    0
    heart burn
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Irreducible hernia
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Loose stools
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 63 (0.00%)
         occurrences all number
    2
    0
    Loss of appetite
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences all number
    1
    1
    Nausea
         subjects affected / exposed
    1 / 64 (1.56%)
    3 / 63 (4.76%)
         occurrences all number
    1
    3
    Rectal bleeding
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    increased urinary frequency
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Nephritis interstitial
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Urethra prolapse
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Renal function deterioration
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Blood in urine
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Blister
         subjects affected / exposed
    0 / 64 (0.00%)
    4 / 63 (6.35%)
         occurrences all number
    0
    4
    Cracked skin
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Eczema
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 63 (3.17%)
         occurrences all number
    0
    2
    Intertrigo
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Lipohypertrophy
         subjects affected / exposed
    3 / 64 (4.69%)
    0 / 63 (0.00%)
         occurrences all number
    3
    0
    Skin abrasion
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Skin rash
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Itchy skin
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 63 (3.17%)
         occurrences all number
    0
    2
    Back stiffness
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Fall
         subjects affected / exposed
    2 / 64 (3.13%)
    1 / 63 (1.59%)
         occurrences all number
    2
    1
    Pain
         subjects affected / exposed
    17 / 64 (26.56%)
    7 / 63 (11.11%)
         occurrences all number
    17
    7
    Painful extemities
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    2
    0
    Muscle stiffness
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences all number
    1
    1
    Fracture
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Muscle cramps
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    trapetiumectomy
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Hyperkalaemia
         subjects affected / exposed
    1 / 64 (1.56%)
    2 / 63 (3.17%)
         occurrences all number
    1
    2
    Hypoglycaemia
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences all number
    1
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences all number
    1
    1
    Testosterone low
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Infections and infestations
    Infection
         subjects affected / exposed
    8 / 64 (12.50%)
    9 / 63 (14.29%)
         occurrences all number
    8
    9
    Cold
         subjects affected / exposed
    5 / 64 (7.81%)
    1 / 63 (1.59%)
         occurrences all number
    5
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Flu like symptoms
         subjects affected / exposed
    3 / 64 (4.69%)
    0 / 63 (0.00%)
         occurrences all number
    3
    0
    Influenza
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Ulcer
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    2
    0
    Nasal infection
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    2 / 64 (3.13%)
    2 / 63 (3.17%)
         occurrences all number
    2
    2
    Cellulitis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 64 (3.13%)
    5 / 63 (7.94%)
         occurrences all number
    2
    5
    Urinary tract infection
         subjects affected / exposed
    1 / 64 (1.56%)
    4 / 63 (6.35%)
         occurrences all number
    1
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Sep 2010
    IMP labels amended
    21 Dec 2011
    1) Change to Inclusion criteria to add a history of a raised intact parathyroid hormone level between 65 pg/ml and 200pg/ml in the 3 months preceding screening visit (or at screening as previously stated). 2) Clarification of the open label phase of the trial 3) Clarification of the deviation from annex 13 compliant labelling.
    18 Jun 2014
    Inclusion criteria amended.

    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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