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    Clinical Trial Results:
    Multicenter, randomized, 52-week trial to determine the efficacy, adherence, safety, and tolerability of natural calcium and vitamin D3 and vitamin K2 supplementation, respectively, in postmenopausal women with newly diagnosed osteopenia

    Summary
    EudraCT number
    		 2020-003579-16
    Trial protocol
    		 SK   CZ  
    Global end of trial date
    19 Jan 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Jul 2026
    First version publication date
    16 Jul 2026
    Other versions
    Summary report(s)
    		 Delay in submission of clinical trial results - EudraCT number 2020-003579-16
    BIOMIN_ANNEX I – CLINICAL STUDY SYNOPSIS

    Trial information

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    Trial identification
    Sponsor protocol code
    BIOMIN
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Biomin, a.s.
    Sponsor organisation address
    Potočná 1/1, Cífer, Slovakia, 91943
    Public contact
    Dr. Jana Misenko, BIOMIN, a. s., +421 918725409, misenko@biomin.sk
    Scientific contact
    Dr. Jana Misenko, BIOMIN, a. s., +421 918725409, misenko@biomin.sk
    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
    26 Aug 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Jan 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jan 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluation of treatment efficacy by comparing the percentage change in bone density and selected parameters of bone quality and bone metabolism from the "Screening" day to the "End of Study" day between two groups of patients (with or without vitamin K2 supplementation)
    Protection of trial subjects
    All subjects provided written informed consent before any study-specific procedures were performed and were informed about the nature, objectives, potential risks and benefits of the trial, as well as their right to withdraw from the trial at any time without giving a reason. The study was conducted in accordance with the Declaration of Helsinki, ICH-GCP and applicable Slovak and Czech legislation, after approval by the competent authorities and ethics committees. Subject protection was ensured by protocol-defined inclusion and exclusion criteria, exclusion of subjects with clinically significant calcium/PTH/vitamin D abnormalities or relevant comorbidities, and regular monitoring of health status, concomitant medication, adverse events and serious adverse events throughout the trial. All study examinations were non-invasive, except for routine blood and urine sampling. Laboratory safety parameters, including serum calcium, phosphate, magnesium, PTH, vitamin D and urinary calcium/phosphate, were monitored according to the protocol. Clinically significant abnormalities were assessed by the investigator. Adverse events were recorded from informed consent onwards and SAEs were reported to the sponsor within 24 hours. Subjects were insured for participation in the clinical trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2021
    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
    Slovakia: 95
    Country: Number of subjects enrolled
    Czechia: 31
    Worldwide total number of subjects
    126
    EEA total number of subjects
    126
    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)
    46
    From 65 to 84 years
    80
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients must meet all criteria to participate: Signed informed consent prior to study. Mentally competent to understand & sign consent. Age ≥ 60 years. Osteopenia (T-score -1 to -2.5 SD in L1-L4, total hip or femoral neck). No prior osteoporosis treatment. No recent (1 month) Ca, vit D3/K2 intake. Densitometry within 30 days.

    Period 1
    Period 1 title
    Treatment period: Randomisation to EoS (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 Biomin H 1110 mg Ca + vitamin D3 + vitamin K2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Biomin H
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral powder in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Biomin H was administered orally as one sachet once daily, corresponding to 1,110 mg of calcium. The sachet content was dispersed in 100 ml of liquid, such as water, juice or milk, and taken immediately. The product was administered in the evening, at least 2 hours after food, preferably on an empty stomach. Subjects were advised not to eat for 1–2 hours after administration. Treatment duration was 52 weeks / 12 months

    Investigational medicinal product name
    Vitamin K2D3 Pro
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    VITAMIN K2D3 Pro was administered orally as one capsule once daily. Each capsule contained vitamin K2 70 micrograms, in the form of menaquinone-7, and vitamin D3 1,000 IU, in the form of cholecalciferol. The capsule was taken preferably in the morning after food and swallowed with a sufficient amount of liquid. Treatment duration was 52 weeks / 12 months.

    Arm title
    		 Group B
    Arm description
    		 Biomin H 1110 mg Ca + vitamin D3
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Biomin H
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral powder in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Biomin H was administered orally as one sachet once daily, corresponding to 1,110 mg of calcium. The sachet content was dispersed in 100 ml of liquid, such as water, juice or milk, and taken immediately. The product was administered in the evening, at least 2 hours after food, preferably on an empty stomach. Subjects were advised not to eat for 1–2 hours after administration. Treatment duration was 52 weeks / 12 months

    Investigational medicinal product name
    Vitamin D3 FORTE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    VITAMIN D3 FORTE was administered orally as one capsule once daily. Each capsule contained vitamin D3 1,000 IU, in the form of cholecalciferol. The capsule was taken preferably in the morning after food and swallowed with a sufficient amount of liquid. Treatment duration was 52 weeks / 12 months.

    Arm title
    		 Group C
    Arm description
    		 Ovovital Forte 600 mg Ca + vitamin D3 + vitamin K2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ovovital Forte
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral powder in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Ovovital Forte was administered orally as one sachet once daily, corresponding to 600 mg of calcium. The sachet content was dispersed in 100 ml of liquid, such as water, juice or milk, and taken immediately. The product was administered in the evening, at least 2 hours after food, preferably on an empty stomach. Subjects were advised not to eat for 1–2 hours after administration. Treatment duration was 52 weeks / 12 months

    Investigational medicinal product name
    Vitamin K2D3 Pro
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    VITAMIN K2D3 Pro was administered orally as one capsule once daily. Each capsule contained vitamin K2 70 micrograms, in the form of menaquinone-7, and vitamin D3 1,000 IU, in the form of cholecalciferol. The capsule was taken preferably in the morning after food and swallowed with a sufficient amount of liquid. Treatment duration was 52 weeks / 12 months.

    Arm title
    		 Group D
    Arm description
    		 Ovovital Forte 600 mg Ca + vitamin D3
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ovovital Forte
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral powder in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Ovovital Forte was administered orally as one sachet once daily, corresponding to 600 mg of calcium. The sachet content was dispersed in 100 ml of liquid, such as water, juice or milk, and taken immediately. The product was administered in the evening, at least 2 hours after food, preferably on an empty stomach. Subjects were advised not to eat for 1–2 hours after administration. Treatment duration was 52 weeks / 12 months

    Investigational medicinal product name
    Vitamin D3 FORTE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    VITAMIN D3 FORTE was administered orally as one capsule once daily. Each capsule contained vitamin D3 1,000 IU, in the form of cholecalciferol. The capsule was taken preferably in the morning after food and swallowed with a sufficient amount of liquid. Treatment duration was 52 weeks / 12 months.

    Number of subjects in period 1
    		Group A Group B Group C Group D
    Started
    33
    31
    32
    30
    Completed
    28
    28
    31
    29
    Not completed
    5
    3
    1
    1
         Adverse event, serious fatal
    -
    1
    -
    -
         Consent withdrawn by subject
    3
    -
    -
    1
         Adverse event, non-fatal
    1
    -
    -
    -
         Lost to follow-up
    1
    2
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Biomin H 1110 mg Ca + vitamin D3 + vitamin K2

    Reporting group title
    Group B
    Reporting group description
    		 Biomin H 1110 mg Ca + vitamin D3

    Reporting group title
    Group C
    Reporting group description
    		 Ovovital Forte 600 mg Ca + vitamin D3 + vitamin K2

    Reporting group title
    Group D
    Reporting group description
    		 Ovovital Forte 600 mg Ca + vitamin D3

    Reporting group values
    		 Group A Group B Group C Group D Total
    Number of subjects
    		 33 31 32 30 126
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 9 12 12 13 46
        From 65-84 years
    		 24 19 20 17 80
        85 years and over
    		 0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 33 31 32 30 126
        Male
    		 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Biomin H 1110 mg Ca + vitamin D3 + vitamin K2

    Reporting group title
    Group B
    Reporting group description
    		 Biomin H 1110 mg Ca + vitamin D3

    Reporting group title
    Group C
    Reporting group description
    		 Ovovital Forte 600 mg Ca + vitamin D3 + vitamin K2

    Reporting group title
    Group D
    Reporting group description
    		 Ovovital Forte 600 mg Ca + vitamin D3

    Primary: Change in DXA T-score from baseline to EoS

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    End point title
    		 Change in DXA T-score from baseline to EoS
    End point description
    End point type
    Primary
    End point timeframe
    Change from Screening visit to EoS visit at 12 months
    End point values
    		 Group A Group B Group C Group D
    Number of subjects analysed
    28
    28
    30
    29
    Units: T-score
        arithmetic mean (standard deviation)
    0.232 ( 0.471 )
    0.000 ( 0.301 )
    0.150 ( 0.497 )
    -0.003 ( 0.260 )
    Statistical analysis title
    		 Comparison of change in DXA T-score
    Comparison groups
    Group A v Group B v Group C v Group D
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.069
    Method
    		 ANOVA
    Confidence interval
    Notes
    [1] - Four-arm between-group comparison of change from Screening/baseline to End of Study across Groups A, B, C and D using one-way ANOVA. No formal superiority, non-inferiority or equivalence hypothesis was specified.

    Secondary: Change in parathyroid hormone from baseline to End of Study

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    End point title
    		 Change in parathyroid hormone from baseline to End of Study
    End point description
    End point type
    Secondary
    End point timeframe
    Screening to End of Study / Day 360 ± 10 days
    End point values
    		 Group A Group B Group C Group D
    Number of subjects analysed
    26
    28
    31
    27
    Units: pg/mL
        arithmetic mean (standard deviation)
    -2.05 ( 9.75 )
    -3.65 ( 10.97 )
    -6.28 ( 12.95 )
    -1.93 ( 11.34 )
    No statistical analyses for this end point

    Secondary: Change in osteocalcin from baseline to End of Study

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    End point title
    		 Change in osteocalcin from baseline to End of Study
    End point description
    End point type
    Secondary
    End point timeframe
    Screening to End of Study / Day 360 ± 10 days
    End point values
    		 Group A Group B Group C Group D
    Number of subjects analysed
    22
    25
    29
    26
    Units: ng/mL
        arithmetic mean (standard deviation)
    -2.81 ( 3.50 )
    -1.71 ( 5.47 )
    -2.98 ( 5.87 )
    -2.26 ( 5.71 )
    No statistical analyses for this end point

    Secondary: Change in CTX from baseline to End of Study

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    End point title
    		 Change in CTX from baseline to End of Study
    End point description
    End point type
    Secondary
    End point timeframe
    Screening to End of Study / Day 360 ± 10 days
    End point values
    		 Group A Group B Group C Group D
    Number of subjects analysed
    24
    24
    28
    25
    Units: pg/mL
        arithmetic mean (standard deviation)
    -66.76 ( 153.59 )
    -72.24 ( 126.19 )
    -81.02 ( 163.97 )
    49.71 ( 335.98 )
    No statistical analyses for this end point

    Secondary: Change in TBS from baseline to End of Study

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    End point title
    		 Change in TBS from baseline to End of Study
    End point description
    Assessment of changes in TBS bone quality parameter from baseline to End of Study.
    End point type
    Secondary
    End point timeframe
    Baseline to End of Study / Day 360 ± 10 days
    End point values
    		 Group A Group B Group C Group D
    Number of subjects analysed
    18
    21
    23
    21
    Units: score
        arithmetic mean (standard deviation)
    0.0081 ( 0.0523 )
    -0.0027 ( 0.0366 )
    0.0081 ( 0.0410 )
    -0.0030 ( 0.0452 )
    No statistical analyses for this end point

    Secondary: Change in 3D-DXA / 3D Shaper-derived bone quality parameters from baseline to End of Study.

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    End point title
    		 Change in 3D-DXA / 3D Shaper-derived bone quality parameters from baseline to End of Study.
    End point description
    Trabecular vBMD Total
    End point type
    Secondary
    End point timeframe
    Baseline to End of Study / Day 360 ± 10 days
    End point values
    		 Group A Group B Group C Group D
    Number of subjects analysed
    20
    23
    25
    24
    Units: mg/cm3
        arithmetic mean (standard deviation)
    1.23 ( 8.92 )
    -3.50 ( 10.48 )
    2.50 ( 9.44 )
    -3.54 ( 7.78 )
    No statistical analyses for this end point

    Secondary: Treatment compliance during the 52-week treatment period

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    End point title
    		 Treatment compliance during the 52-week treatment period
    End point description
    Assessment of compliance based on returned/used study medication during the treatment period.
    End point type
    Secondary
    End point timeframe
    Day 0 to End of Study / Day 360 ± 10 days
    End point values
    		 Group A Group B Group C Group D
    Number of subjects analysed
    29
    26
    29
    27
    Units: percent
        arithmetic mean (standard deviation)
    98.23 ( 7.55 )
    93.41 ( 10.78 )
    93.32 ( 14.95 )
    95.61 ( 7.87 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE were collected from ICF until the EoS visit. Ongoing events were followed according to the investigator’s judgement. SAEs were reported to the sponsor within 24 hours and non-serious AEs within 7 days.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    28.0
    Reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Biomin H 1110 mg Ca + vitamin D3 + vitamin K2

    Reporting group title
    Group B
    Reporting group description
    		 Biomin H 1110 mg Ca + vitamin D3

    Reporting group title
    Group C
    Reporting group description
    		 Ovovital Forte 600 mg Ca + vitamin D3 + vitamin K2

    Reporting group title
    Group D
    Reporting group description
    		 Ovovital Forte 600 mg Ca + vitamin D3

    Serious adverse events
    		 Group A Group B Group C Group D
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 33 (3.03%)
    3 / 31 (9.68%)
    0 / 32 (0.00%)
    1 / 30 (3.33%)
         number of deaths (all causes)
    0
    1
    0
    0
         number of deaths resulting from adverse events
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Radius fracture
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Pulmonary embolism
    Additional description: The same subject has as well Deep vein thrombosis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 31 (3.23%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 31 (3.23%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Breast operation
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 31 (3.23%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 31 (3.23%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 31 (3.23%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group A Group B Group C Group D
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 33 (15.15%)
    7 / 31 (22.58%)
    4 / 32 (12.50%)
    5 / 30 (16.67%)
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 33 (3.03%)
    3 / 31 (9.68%)
    0 / 32 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    1
    3
    0
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 33 (3.03%)
    2 / 31 (6.45%)
    2 / 32 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    3
    2
    3
    1
    Arthralgia
    Additional description: "Hip pain"
         subjects affected / exposed
    2 / 33 (6.06%)
    1 / 31 (3.23%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    0
    0
    2
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 33 (6.06%)
    3 / 31 (9.68%)
    1 / 32 (3.13%)
    0 / 30 (0.00%)
         occurrences all number
    2
    4
    1
    0
    Viral infection
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 31 (3.23%)
    2 / 32 (6.25%)
    0 / 30 (0.00%)
         occurrences all number
    0
    1
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Nov 2021
    Substantial protocol amendment implementing Protocol Version 4 dated 24 November 2021. The amendment modified the eligibility criteria by lowering the minimum age of eligible subjects from 65 years to 60 years. It also modified the urine sampling procedure for safety laboratory assessments, replacing 24-hour urine collection with morning urine sample assessment.
    17 Mar 2023
    Substantial protocol amendment implementing Protocol Version 5.0 dated 17 March 2023. The clinical trial in the Slovak Republic was initiated under approved Protocol Version 3 dated 3 March 2021 and recruitment subsequently continued under approved Protocol Version 4 dated 24 November 2021. Recruitment was completed on 3 February 2023 after 120 subjects had been randomized. Protocol Version 5.0 was submitted mainly to update the planned/actual number of subjects in the trial and to align the protocol documentation with the completed recruitment status. The amendment did not change the investigational medicinal product, treatment arms, treatment duration or main study objectives.

    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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