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    Summary
    EudraCT Number:2020-003579-16
    Sponsor's Protocol Code Number:BIOMIN
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-10-06
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2020-003579-16
    A.3Full title of the trial
    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
    Multicentrické, randomizované, 52 týždňov trvajúce skúšanie na
    stanovenie účinnosti, adherencie, bezpečnosti a znášanlivosti
    suplementácie prírodným vápnikom a vitamínom D3 s respektíve bez
    vitamínu K2 u postmenopauzálnych žien s novodiagnostikovanou
    osteopéniou
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of supplementation of natural calcium and vitamin D3 with or
    without vitamin K2, in postmenopausal women with osteopenia
    Účinok suplementácie prírodného vápnika a vitamínu D3 s vitamínom K2 a
    bez neho u postmenopauzálnych žien s osteopéniou
    A.4.1Sponsor's protocol code numberBIOMIN
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBIOMIN, a. s.
    B.1.3.4CountrySlovakia
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBIOMIN, a. s.
    B.4.2CountrySlovakia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBIOMIN, a. s.
    B.5.2Functional name of contact pointAdam Szabo
    B.5.3 Address:
    B.5.3.1Street AddressPotočná 1/1
    B.5.3.2Town/ cityCífer
    B.5.3.3Post code919 43
    B.5.3.4CountrySlovakia
    B.5.4Telephone number+421915991 375
    B.5.6E-mailadamkoszabo@gmail.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Biomin H
    D.2.1.1.2Name of the Marketing Authorisation holderBIOMIN, a. s.
    D.2.1.2Country which granted the Marketing AuthorisationSlovakia
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Oral powder in sachet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Osteopenia
    E.1.1.1Medical condition in easily understood language
    Osteopenia
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.0
    E.1.2Level LLT
    E.1.2Classification code 10021059
    E.1.2Term Hypophosphatemia
    E.1.2System Organ Class 100000004861
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10021689
    E.1.2Term Increased thirst
    E.1.2System Organ Class 100000004867
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10016766
    E.1.2Term Flatulence
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10081649
    E.1.2Term Rebound gastric hypersecretion
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10045304
    E.1.2Term Ulcer gastric
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10010774
    E.1.2Term Constipation
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10004222
    E.1.2Term Belching
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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)
    Zhodnotenie účinnosti liečby porovnaním percentuálnej zmeny kostnej
    denzity a vybraných parametrov kvality kosti a kostného metabolizmu od
    dňa „Screening" až po deň „End of Study" medzi dvomi skupinami
    pacientov (s resp. bez suplementácie vitamínom K2)
    E.2.2Secondary objectives of the trial
    • Comparison of the percentage change of selected new markers of bone turnover (sclerostin, DKK-1) and sarcopenia parameters from the day of "Screening" to the day of "End of Study" between two groups of patients (with or without vitamin K2 supplementation)
    • Comparison of frequency and type of adverse reactions (tolerability), aortic calcifications (safety) and clinical fractures between two groups of patients
    • Comparison of adherence to therapy between two groups of patients
    • Porovnanie percentuálnej zmeny vybraných nových markerov
    kostného obratu (sclerostínu, DKK-1) a parametrov sarkopénie od dňa
    „Screening" až po deň „End of Study" medzi dvomi skupinami pacientov
    (s resp. bez suplementácie vitamínom K2)
    • Porovnanie frekvencie výskytu a typu nežiaducich účinkov
    (znášanlivosť), kalcifikátov v aorte (bezpečnosť) a klinických fraktúr
    medzi dvomi skupinami pacientov
    • Porovnanie adherencie k terapii medzi dvomi skupinami pacientov
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The patient must not participate in the trial if she does not meet all of
    the inclusion criteria below
    1. The patient must sign an informed consent form before performing
    any examination for the purpose of the trial.
    2. The patient must be mentally competent / self-able, able to read,
    understand and sign informed consent.
    3. Age: 60 and older.
    4. Diagnosed osteopenia - T-score (-1 SD to -2.5 SD) in the L1-4 area of
    the lumbar spine and / or total hip and / or femoral neck.
    5. Without prior specific treatment for osteoporosis.
    6. At present (1 month before the screening examination) does not use
    calcium resp. vitamin D3 (or active forms of vitamin D3) or K2 in the
    form of drugs or nutritional supplements.
    7. The patient had a densitometric examination confirming osteopenia at
    most 30 days before the Screening Visit.
    Pacientka sa nesmie zúčastniť skúšania, ak nespĺňa všetky nižšie
    uvedené inklúzne kritériá
    1. Pacientka musí pred realizáciou akéhokoľvek vyšetrenia na účely
    skúšania podpísať informovaný súhlas.
    2. Pacientka musí byť psychicky spôsobilá/svojprávna, schopná
    prečítať, pochopiť a podpísať informovaný súhlas.
    3. Vek: 60 a viac rokov.
    4. Diagnostikovaná osteopénia – T- score (-1 SD až -2,5 SD) v oblasti
    L1-4 lumbálnej chrbtice a/alebo total hip a/alebo krčka stehnovej kosti.
    5. Bez predchádzajúcej špecifickej liečby osteoporózy.
    6. V súčasnosti (1 mesiac pred screeningovým vyšetrením) neužíva
    vápnik resp. vitamín D3 (ani aktívne formy vitamínu D3) alebo K2 vo
    forme liekov resp. výživových doplnkov.
    7. Pacientka mala v čase najviac 30 dní pred Screeningovou návštevou
    realizované denzitometrické vyšetrenie potvrdzujúce osteopéniu.
    E.4Principal exclusion criteria
    A patient may not take part in the trial if she meets at least one of the
    exclusion criteria below
    1. The patient refused to sign the informed consent or is not independent
    or capable of reading, understanding or signing informed consent.
    2. The patient is less than 60 years old.
    3. The patient is taking medicines for osteoporosis.
    4. A patient with a vertebral body fracture.
    5. Gender: male
    6. Diagnosed diseases leading to secondary osteoporosis.
    7. Patient with a history of calcium allergy, chronic diarrhea, heart disease (NYHA III, IV), kidney stones, kidney disease (CKD 3 and more),
    sarcoidosis, absorption disorders, other serious diseases.
    8. A patient with a clinically significantly elevated parathyroid hormone
    level at the last blood biochemical examination.
    9. A patient with a clinically significantly elevated blood calcium level at
    the last blood biochemical examination.
    10. Patient with calcium above 4 mg / kg / day.
    11. Patient with severe vitamin D deficiency (≤ 10ng / ml, ≤ 25nmol / l).
    12. The patient is taking at least one of the following drugs:
    cardioglycosides, coumarin drugs (eg Warfarin), anticoagulants,
    phenylbutazone, phenytoin, chlorpromazine, calcitonin, corticosteroids,
    phytic acid, nalidixic acid, nicardipine, nimodipicillinicillin, oxyphenoic
    acid, pentobarbital, iron preparations, tetracycline antibiotics (especially
    doxycycline), vitamin A, active form of vitamin D (eg Alfacalcidiol,
    Rocaltrol), vitamin B7 (Biotin).
    13. Patient with hypersensitivity to the active substance or to any of the
    excipients of the monitored treatment (calcium, magnesium, phosphorus
    and other trace elements).
    14. The patient is participating in different clinical trial.
    Pacientka sa nesmie zúčastniť skúšania, ak spĺňa aspoň jedno z nižšie
    uvedených exklúznych kritérií
    1. Pacientka odmietla podpísať informovaný súhlas alebo nie je
    svojprávna resp. spôsobilá prečítať, pochopiť alebo podpísať
    informovaný súhlas.
    2. Pacientka má menej ako 60 rokov.
    3. Pacientka užíva/ užívala lieky na osteoporózu.
    4. Pacientka s nálezom fraktúry tela stavca.
    5. Pohlavie: muž
    6. Diagnostikované ochorenia vedúce k sekundárnej osteoporóze.
    7. Pacientka s anamnézou alergie na vápnik, chronických hnačiek,
    ochorenia srdca (NYHA III, IV), obličkové kamene, ochorenia obličiek
    (CKD 3 a viac), sarkoidóza, poruchy absorpcie, iné závažné ochorenia.
    8. Pacientka s klinicky signifikantne zvýšenou hladinou parathormónu
    pri poslednom biochemickom vyšetrení krvi.
    9. Pacientka s klinicky signifikantne zvýšenou hladinou vápnika v krvi
    pri poslednom biochemickom vyšetrení krvi.
    10. Pacientka s kalciúriou nad 4 mg/kg/deň.
    11. Pacientka so závažnou deficienciou vitamínu D (≤ 10ng/ml, ≤
    25nmol/l).
    12. Pacientka užíva aspoň jedno z nasledujúcich liečiv: kardioglykozidy,
    kumarínové liečivá (pr. Warfarín), antikoagulanciá, fenylbutazón,
    fenytoín, chlórpromazín, kalcitonín, kortikosteroidy, kyselina fytová,
    kyselina nalidixová, nikardipín, nimodipín, oxyfenbutazón, kyselina
    paraaminosalicylová, penicilínové antibiotiká, pentobarbital, prípravky s
    obsahom železa, tetracyklínové antibiotiká (najmä doxycyklín), vitamín
    A, aktívna forma vitamínu D (pr. Alfacalcidiol, Rocaltrol), vitamín B7
    (Biotín).
    13. Pacientka s hypersenzitivitou na liečivú látku alebo akékoľvek
    pomocné látky sledovanej liečby (kalcium, magnézium, fosfor a iné
    prvky v stopových množstvách).
    14. Pacientka sa zúčastňuje iného klinického skúšania.
    E.5 End points
    E.5.1Primary end point(s)
    Stabilized bone density
    Stabilizovaná kostná denzita
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 týždňov
    E.5.2Secondary end point(s)
    Preventing the formation of vertebral body fractures
    Zabránenie tvorbe fraktúr tela stavcov
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 týždňov
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    adherence and tolerability
    adherencia a znášanlivosti
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    výživový doplnok
    dietary supplement
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    -The patient does not meet all inclusive resp. meets at least one
    exclusion criterion
    -The patient withdraws the informed consent
    -Adverse effects
    -Doctor's decision
    -Croup violation
    - Lost to follow-up
    -Study completed by sponsor
    -Administrative reason: SÚKL will end the testing resp. Ethics
    committee.
    -Pacientka nespĺňa všetky inklúzne resp. spĺňa aspoň jedno exklúzne
    kritérium
    -Pacientka stiahne informovaný súhlas
    -Nežiaduce účinky
    -Rozhodnutie lekára
    -Porušenie protokolu
    -„Lost to follow-up"
    -Štúdia ukončená sponzorom
    -Administratívny dôvod: Skúšanie ukončí SÚKL resp. Etická komisia.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The patient will continue to be monitored by her doctor
    Pacientka bude naďalej sledovaná u svojho lekára
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-03-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-13
    P. End of Trial
    P.End of Trial StatusOngoing
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