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    Clinical Trial Results:
    Clinical Trial of pharmacokinetics of calcifediol (25OHD3) in women with postmenopausal osteoporosis

    Summary
    EudraCT number
    		 2015-005303-91
    Trial protocol
    		 IT  
    Global end of trial date
    25 Sep 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jun 2021
    First version publication date
    30 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VIT_D_2015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 VIT_D_2015: VIT_D_2015
    Sponsors
    Sponsor organisation name
    Azienda Ospedaliera Universitaria Senese
    Sponsor organisation address
    VIALE MARIO BRACCI 16, Siena, Italy, 53100
    Public contact
    UOC Medicina Interna 1, Prof. Stefano Gonnelli, Azienda Ospedaliera Universitaria Senese, +39 0577585468, gonnelli@unisi.it
    Scientific contact
    UOC Medicina Interna 1, Prof. Stefano Gonnelli, Azienda Ospedaliera Universitaria Senese, +39 0577585468, gonnelli@unisi.it
    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
    29 Apr 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Sep 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Sep 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the pharmacokinetic of 25(OH)D3 in postmenopausal women with osteoporosis treated for 6 months with two different dosages of calcifediol. To evaluate the efficacy of two different dosages of calcifediol in the achievement of serum levels of 25(OH)D3 higher than 30 ng/ml in women with postmenopausal osteoporosis.
    Protection of trial subjects
    Not Applicable
    Background therapy
    		 Not Applicable
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Apr 2017
    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
    Italy: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    35
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Enrolment at department of internal Medicine 1 at Univ. Hosp. Siena (From 04/2017 to 02/2019) Postmenopausal women (amenorrhea) for at least 5 years, Age between 55 and 70 years, Lumbar or femoral T-score ≤ -2.5SD, Plasma levels of 25OHD3 between 10 and 20 ng/ml, Informed consenst signed, Willingness and capacity to adhere to study protocol

    Pre-assignment
    Screening details
    		 92 patients were screened, of which 42 excluded for non-compliance with the inclusion criteria - Postmenopausal women (amenorrhea) for at least 5 years - Age between 55 and 70 years - Lumbar or femoral T-score ≤ -2.5 SD - Plasma levels of 25OHD3 between 10 and 20 ng/ml

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not Applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Low dose Arm
    Arm description
    		 Patients will receive 28 drops per week of calcifediol equal to 140 mcg for six months (= 4 drops per day) Treatment will last 6 months. After 7, 14, 21, 30, 90 and 180 days of therapy respectively, the patient will undergo the scheduled check-ups with evaluation Calcemia, phosphorus, creatinine, calcium, phosphaturia, creatininuria (24 hour urine), total alkaline phosphatase and bone , serum cross-laps, 25OHD, 1.25 (OH) 2D3 and PTH. Muscle strength evaluation by Hand-grip.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Calcifediol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops, suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Patients will receive 28 drops of calcifediol (oral use) per week equal to 140 mcg for six months.

    Arm title
    		 High dose Arm
    Arm description
    		 Patients will receive 42 drops per week of calcifediol equal to 210 mcg for six months (= 4 drops per day) Treatment will last 6 months. After 7, 14, 21, 30, 90 and 180 days of therapy respectively, the patient will undergo the scheduled check-ups with evaluation Calcemia, phosphorus, creatinine, calcium, phosphaturia, creatininuria (24 hour urine), total alkaline phosphatase and bone , serum cross-laps, 25OHD, 1.25 (OH) 2D3 and PTH. Muscle strength evaluation by Hand-grip.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Calcifediol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops, suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Patients will receive 42 drops of calcifediol (oral use) per week equal to 210 mcg for six months.

    Number of subjects in period 1
    		Low dose Arm High dose Arm
    Started
    25
    25
    Completed
    23
    23
    Not completed
    2
    2
         Consent withdrawn by subject
    1
    -
         Logistical problems
    1
    1
         Health problems not related to study
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Low dose Arm
    Reporting group description
    		 Patients will receive 28 drops per week of calcifediol equal to 140 mcg for six months (= 4 drops per day) Treatment will last 6 months. After 7, 14, 21, 30, 90 and 180 days of therapy respectively, the patient will undergo the scheduled check-ups with evaluation Calcemia, phosphorus, creatinine, calcium, phosphaturia, creatininuria (24 hour urine), total alkaline phosphatase and bone , serum cross-laps, 25OHD, 1.25 (OH) 2D3 and PTH. Muscle strength evaluation by Hand-grip.

    Reporting group title
    High dose Arm
    Reporting group description
    		 Patients will receive 42 drops per week of calcifediol equal to 210 mcg for six months (= 4 drops per day) Treatment will last 6 months. After 7, 14, 21, 30, 90 and 180 days of therapy respectively, the patient will undergo the scheduled check-ups with evaluation Calcemia, phosphorus, creatinine, calcium, phosphaturia, creatininuria (24 hour urine), total alkaline phosphatase and bone , serum cross-laps, 25OHD, 1.25 (OH) 2D3 and PTH. Muscle strength evaluation by Hand-grip.

    Reporting group values
    		 Low dose Arm High dose Arm Total
    Number of subjects
    		 25 25 50
    Age categorical
    Postmenopausal women 55-70 years
    Units: Subjects
        Adults (18-64 years)
    		 17 18 35
        From 65-84 years
    		 8 7 15
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.4 ( 7.3 ) 61.6 ( 8.2 ) -
    Gender categorical
    Female
    Units: Subjects
        Female
    		 25 25 50
    BMD
    Bone mineral density
    Units: gram(s)/square meter
        arithmetic mean (standard deviation)
    		 9670 ( 1600 ) 9580 ( 1040 ) -
    25OH-Vit. D
    Fasting venous blood sample
    Units: nanogram(s)/millilitre
        arithmetic mean (standard deviation)
    		 15.2 ( 4.8 ) 16.1 ( 5.1 ) -
    BMI
    Body Mass Index
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    		 26.1 ( 3.2 ) 25.5 ( 3.9 ) -
    Serum Calcium
    Units: millimole(s)/litre
        arithmetic mean (standard deviation)
    		 2.33 ( 0.1 ) 2.35 ( 0.1 ) -
    Calciuria
    Units: milligram(s)/24 hours
        arithmetic mean (standard deviation)
    		 158.0 ( 70.4 ) 149.5 ( 69.0 ) -
    1-25OHD2
    Units: nanogram(s)/millilitre
        arithmetic mean (standard deviation)
    		 0.045 ( 0.012 ) 0.045 ( 0.011 ) -
    Handgrip
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 18.5 ( 4.7 ) 18.3 ( 4.8 ) -
    Subject analysis sets

    Subject analysis set title
    Analysys Anova
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    For the comparison between the two independent groups of the study, the T-test will be used, or, if necessary, the non-parametric equivalent of the Mann-Whitney test

    Subject analysis sets values
    		 Analysys Anova
    Number of subjects
    46
    Age categorical
    Postmenopausal women 55-70 years
    Units: Subjects
        Adults (18-64 years)
    33
        From 65-84 years
    13
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    61.8 ( 7.9 )
    Gender categorical
    Female
    Units: Subjects
        Female
    46
    BMD
    Bone mineral density
    Units: gram(s)/square meter
        arithmetic mean (standard deviation)
    9650 ( 1390 )
    25OH-Vit. D
    Fasting venous blood sample
    Units: nanogram(s)/millilitre
        arithmetic mean (standard deviation)
    15.7 ( 6.3 )
    BMI
    Body Mass Index
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    25.9 ( 4.2 )
    Serum Calcium
    Units: millimole(s)/litre
        arithmetic mean (standard deviation)
    2.35 ( 0.1 )
    Calciuria
    Units: milligram(s)/24 hours
        arithmetic mean (standard deviation)
    155.1 ( 79.4 )
    1-25OHD2
    Units: nanogram(s)/millilitre
        arithmetic mean (standard deviation)
    0.045 ( 0.014 )
    Handgrip
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    18.3 ( 4.5 )

    End points

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    End points reporting groups
    Reporting group title
    Low dose Arm
    Reporting group description
    		 Patients will receive 28 drops per week of calcifediol equal to 140 mcg for six months (= 4 drops per day) Treatment will last 6 months. After 7, 14, 21, 30, 90 and 180 days of therapy respectively, the patient will undergo the scheduled check-ups with evaluation Calcemia, phosphorus, creatinine, calcium, phosphaturia, creatininuria (24 hour urine), total alkaline phosphatase and bone , serum cross-laps, 25OHD, 1.25 (OH) 2D3 and PTH. Muscle strength evaluation by Hand-grip.

    Reporting group title
    High dose Arm
    Reporting group description
    		 Patients will receive 42 drops per week of calcifediol equal to 210 mcg for six months (= 4 drops per day) Treatment will last 6 months. After 7, 14, 21, 30, 90 and 180 days of therapy respectively, the patient will undergo the scheduled check-ups with evaluation Calcemia, phosphorus, creatinine, calcium, phosphaturia, creatininuria (24 hour urine), total alkaline phosphatase and bone , serum cross-laps, 25OHD, 1.25 (OH) 2D3 and PTH. Muscle strength evaluation by Hand-grip.

    Subject analysis set title
    Analysys Anova
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    For the comparison between the two independent groups of the study, the T-test will be used, or, if necessary, the non-parametric equivalent of the Mann-Whitney test

    Primary: 25OHD3 serum levels at 180 days

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    End point title
    		 25OHD3 serum levels at 180 days
    End point description
    25OHD3 serum levels at 180 days
    End point type
    Primary
    End point timeframe
    25OHD3 serum levels at baseline and 15, 30, 60, 90, 180 days
    End point values
    		 Low dose Arm High dose Arm Analysys Anova
    Number of subjects analysed
    23
    23
    46
    Units: nanogram(s)/millilitre
        arithmetic mean (standard deviation)
    53.9 ( 26.8 )
    67.0 ( 25.0 )
    61.8 ( 26.0 )
    Statistical analysis title
    		 Analysis Anova 25OHD3 serum levels at 180 days
    Statistical analysis description
    Evaluation also at 15, 30, 60, 90 days
    Comparison groups
    Low dose Arm v High dose Arm
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Secondary: 1-25OHD2 serum levels at 180 days

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    End point title
    		 1-25OHD2 serum levels at 180 days
    End point description
    1-25OHD2 serum levels at 180 days
    End point type
    Secondary
    End point timeframe
    1-25OHD2 serum levels at baseline and 15, 30, 60, 90, 180 days
    End point values
    		 Low dose Arm High dose Arm Analysys Anova
    Number of subjects analysed
    23
    23
    46
    Units: nanogram(s)/millilitre
        arithmetic mean (standard deviation)
    0.047 ( 0.031 )
    0.054 ( 0.014 )
    0.051 ( 0.020 )
    Statistical analysis title
    		 Analysis 1-25OHD2 Anova at 180 days
    Comparison groups
    High dose Arm v Low dose Arm
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Secondary: Calcemia at 180 days

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    End point title
    		 Calcemia at 180 days
    End point description
    Serum Total Calcium at 180 days
    End point type
    Secondary
    End point timeframe
    Serum Total Calcium at baseline and 15, 30, 60, 90, 180 days
    End point values
    		 Low dose Arm High dose Arm Analysys Anova
    Number of subjects analysed
    23
    23
    46
    Units: millimole(s)/litre
        arithmetic mean (standard deviation)
    2.43 ( 0.08 )
    2.4 ( 0.08 )
    2.38 ( 0.08 )
    Statistical analysis title
    		 Analysis Calcemia Anova at 180 days
    Statistical analysis description
    Evaluation also at 15, 30, 60, 90 days
    Comparison groups
    Low dose Arm v High dose Arm
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Secondary: Calciuria at 180 days

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    End point title
    		 Calciuria at 180 days
    End point description
    Calciuria at 180 days
    End point type
    Secondary
    End point timeframe
    Calciuria at baseline and 30, 60, 90, 180 days
    End point values
    		 Low dose Arm High dose Arm Analysys Anova
    Number of subjects analysed
    23
    23
    46
    Units: milligram(s)/24 hours
        arithmetic mean (standard deviation)
    203 ( 125 )
    220 ( 112.2 )
    213 ( 117 )
    Statistical analysis title
    		 Calciuria at 180 days Anova Test
    Statistical analysis description
    Evaluation also at 15, 30, 60, 90 days
    Comparison groups
    High dose Arm v Low dose Arm
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Secondary: Muscle strenght (Handgrip) at 180 days

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    End point title
    		 Muscle strenght (Handgrip) at 180 days
    End point description
    Muscle strenght (Handgrip) at 180 days
    End point type
    Secondary
    End point timeframe
    Muscle strenght (Handgrip) at baseline and 30, 60, 90, 180 days
    End point values
    		 Low dose Arm High dose Arm Analysys Anova
    Number of subjects analysed
    23
    23
    46
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    19.6 ( 4.6 )
    21.0 ( 5.5 )
    20.2 ( 4.9 )
    Statistical analysis title
    		 Handgrip Anova Analysis at 180 days
    Statistical analysis description
    Evaluation also at 15, 30, 60, 90 days
    Comparison groups
    High dose Arm v Low dose Arm
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Evaluation of side effects at all visits
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Low dose arm
    Reporting group description
    		 -

    Reporting group title
    High dose arm
    Reporting group description
    		 -

    Serious adverse events
    		 Low dose arm High dose arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Low dose arm High dose arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 25 (4.00%)
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 25 (4.00%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33506314
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