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    Clinical Trial Results:
    Comparative study of the effect of 4-week treatment with ossein-hydroxyapatite compound versus calcium carbonate on bone biomarkers in young women with low calcium intake. Prospective, monocenter, randomized, open-label, two-period,cross-over trial

    Summary
    EudraCT number
    2008-002280-14
    Trial protocol
    FR  
    Global end of trial date
    13 Jan 2009

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Dec 2018
    First version publication date
    28 Dec 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    L00006 CP 403 3A
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pierre Fabre Médicament
    Sponsor organisation address
    45 place Abel Gance, Boulogne, France, 92654
    Public contact
    Dr Mohammed ZAÏM, Institut de Recherche Pierre Fabre (IRPF), +33 (0)5-34-50-61-91, mohammed.zaim@pierre-fabre.com
    Scientific contact
    Dr Mohammed ZAÏM, Institut de Recherche Pierre Fabre (IRPF), +33 (0)5-34-50-61-91, mohammed.zaim@pierre-fabre.com
    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
    13 Jan 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jan 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jan 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study is to compare the effect of 4-week treatment with ossein-hydroxyapatite compound versus calcium carbonate on biochemical markers of bone resorption in young women with low calcium intake.
    Protection of trial subjects
    The study was conducted according to Good Clinical Practice (GCP) (CPMP/ICH/135/95), the principles stated in the Declaration of Helsinki (1964) and its subsequent amendments thereto, and national regulations. The request for authorization by the Competent Authority or its notification (depending on National Regulations) was carried out by the Sponsor. The study protocol and related documents, including the informed consent forms (ICFs), were submitted for approval to independent, local or national Independent Ethics Committees (IECs) and to competent authorities (CAs) before the study set-up, according to national regulations.
    Background therapy
    No specific therapy was given during the study
    Evidence for comparator
    Calcium carbonate is considered to be a well bioavailable form of oral calcium. For the main efficacy criteria (biomarkers of resorption), a wash-out period of 4 weeks is considered sufficient to bring the values noted after the first treatment period back to baseline and thus avoid or minimise any possible carry-over effect.
    Actual start date of recruitment
    09 Sep 2008
    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
    France: 58
    Worldwide total number of subjects
    58
    EEA total number of subjects
    58
    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)
    58
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 72 subjects were offered enrolment in the study. Of them, 12 were not randomised and 60 were effectively included and randomised. Premature withdrawal from therapy occurred in 2 subjects (not inculded in the FAS).

    Pre-assignment
    Screening details
    72 young women with low calcium intake were offered enrolment. Low calcium intake is more frequent in young women than men. Moreover, osteoporosis is more prevalent amongst females than males.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Osteopor-Orocal
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Osteopor
    Investigational medicinal product code
    Other name
    Ossein-hydroxyapatite, L0006
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two tablets of 830 mg to be swallowed with a glass of tap water, twice daily in the morning and evening before meals for four weeks.

    Arm title
    Orocal-Osteopor
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Orocal
    Investigational medicinal product code
    Other name
    Calcium carbonate
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet to be sucked twice daily in the morning and evening before meals for four weeks.

    Number of subjects in period 1
    Osteopor-Orocal Orocal-Osteopor
    Started
    29
    29
    Completed
    29
    29
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Osteopor-Orocal
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Orocal
    Investigational medicinal product code
    Other name
    Calcium carbonate
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet to be sucked twice daily in the morning and evening before meals for four weeks.

    Arm title
    Orocal-Osteopor
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Osteopor
    Investigational medicinal product code
    Other name
    Ossein-hydroxyapatite, L0006
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two tablets of 830 mg to be swallowed with a glass of tap water, twice daily in the morning and evening before meals for four weeks.

    Number of subjects in period 2
    Osteopor-Orocal Orocal-Osteopor
    Started
    29
    29
    Completed
    29
    29

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Osteopor-Orocal
    Reporting group description
    -

    Reporting group title
    Orocal-Osteopor
    Reporting group description
    -

    Reporting group values
    Osteopor-Orocal Orocal-Osteopor Total
    Number of subjects
    29 29 58
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    29 29 58
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    22.6 ± 2.4 21.7 ± 2.2 -
    Gender categorical
    Units: Subjects
        Female
    29 29 58
        Male
    0 0 0
    Height
    Units: cm
        arithmetic mean (standard deviation)
    166.1 ± 7.8 164.0 ± 4.7 -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    57.31 ± 7.68 57.51 ± 5.26 -
    Body Mass Index derived
    Units: kg/m²
        arithmetic mean (standard deviation)
    20.72 ± 1.91 21.40 ± 2.01 -

    End points

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    End points reporting groups
    Reporting group title
    Osteopor-Orocal
    Reporting group description
    -

    Reporting group title
    Orocal-Osteopor
    Reporting group description
    -
    Reporting group title
    Osteopor-Orocal
    Reporting group description
    -

    Reporting group title
    Orocal-Osteopor
    Reporting group description
    -

    Primary: Serum type-I collagen cross-linked C-telopeptide (CTX1)

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    End point title
    Serum type-I collagen cross-linked C-telopeptide (CTX1)
    End point description
    End point type
    Primary
    End point timeframe
    The study main efficacy criterion was the change from baseline in serum concentration of the bone resorption biomarker CTX1 after 4 weeks of treatment.
    End point values
    Osteopor-Orocal Orocal-Osteopor Osteopor-Orocal Orocal-Osteopor
    Number of subjects analysed
    29
    29
    29
    29
    Units: pmol/L
    arithmetic mean (standard deviation)
        Start
    4872.8 ± 2182.1
    4714.1 ± 2260.3
    5168.7 ± 1866.7
    4812.8 ± 2284.8
        End
    4642.3 ± 1406.3
    3961.6 ± 2231.9
    4827.7 ± 1600.3
    4437.5 ± 1833.7
    Statistical analysis title
    Full analysis set
    Comparison groups
    Osteopor-Orocal v Orocal-Osteopor
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.36
    Method
    Test of the three effects of interest
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from subject's inclusion to the end of study. Any SAE occurring during the month following the last administration of the study drug or the end of the study was to be notified to the Sponsor.
    Adverse event reporting additional description
    Any disease existing at subjects' selection was reported in the CRF. At each further visit (or phone call), the occurrence of AEs since the last visit was collected on the basis of subject’s spontaneous reporting, Investigator’s non-leading questioning and/or clinical assessments.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Osteopor-Orocal
    Reporting group description
    -

    Reporting group title
    Orocal-Osteopor
    Reporting group description
    -

    Serious adverse events
    Osteopor-Orocal Orocal-Osteopor
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 29 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 3.3%
    Non-serious adverse events
    Osteopor-Orocal Orocal-Osteopor
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 29 (62.07%)
    12 / 29 (41.38%)
    Surgical and medical procedures
    Dental operation
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dysphonia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Choking
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    vasovagal syncope
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 29 (6.90%)
         occurrences all number
    2
    2
    Dry mouth
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Teething
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2
    Bronchitis
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 29 (6.90%)
         occurrences all number
    2
    2
    Acute tonsillitis
         subjects affected / exposed
    4 / 29 (13.79%)
    0 / 29 (0.00%)
         occurrences all number
    4
    0
    Gastroenteritis
         subjects affected / exposed
    4 / 29 (13.79%)
    2 / 29 (6.90%)
         occurrences all number
    4
    2
    Influenza
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Tooth abscess
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (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
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