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    Summary
    EudraCT Number:2017-001022-17
    Sponsor's Protocol Code Number:170304
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-03-13
    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 ConcernedSweden - MPA
    A.2EudraCT number2017-001022-17
    A.3Full title of the trial
    Vitamin D supplementation to breast cancer patients with adjuvant endocrine treatment – An observational clinical study where the patient is its own control.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vitamin D supplementation to breast cancer survivors with joint pain on treatment with an aromatase inhibitor to reduce their risk for breast cancer relapse. The patients is its own control and pain is measured before and after 12 weeks of vitamin D supplementation
    A.3.2Name or abbreviated title of the trial where available
    VIDEN
    A.4.1Sponsor's protocol code number170304
    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 SponsorBreastcentre, Capio St Gorans Hospital
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportALF Funding
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBreastcentre, Capio St Gorans Hospital
    B.5.2Functional name of contact pointJenny Bergqvist
    B.5.3 Address:
    B.5.3.1Street AddressSt Gorans plan1
    B.5.3.2Town/ cityStockholm
    B.5.3.4CountrySweden
    B.5.4Telephone number+46722339357
    B.5.6E-mailjenny.bergqvist@ki.se
    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 Detremin
    D.2.1.1.2Name of the Marketing Authorisation holderRenapharma AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 drops, solution
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    Breast cancer survivors on adjuvant treatment with an aromatase inhibitor having joint pain
    E.1.1.1Medical condition in easily understood language
    Breast cancer survivors with joint pain on treatment with an aromatase inhibitor to reduce their risk for breast cancer relapse
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to try the hypothesis that vitamin D supplementation reduce joint pain in breast cancer survivors on adjuvant treatment with an aromatase inhibitor
    E.2.2Secondary objectives of the trial
    The secondary objectives is to try the hypothesis that vitamin D supplementation in breast cancer survivors on adjuvant treatment with an aromatase inhibitor reduce fatigue and depression and improve quality of life.
    The effect on the vitamin D levels in serum after 12 weeks of treatment will also be studied.

    The safety objective is to verify that the use of vitamin D is safe and tolerable.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Breast cancer survivors at the Breastcentre, St Gorans Hospital on adjuvant endocrine treatment with an aromatase inhibitor having joint pain
    2. The patient should have no cognitive failure, being able to comprehend oral and written information about the study.
    3. 25 OHD < 50 nmol/L.
    4. Women aged ≥18.
    5. Signed 'informed consent'.
    E.4Principal exclusion criteria
    1. Ongoing vitamin D or calcium supplementation at the time for inclusion.
    2. Serum level of 25-OH vitamin D3 >/= 50 nmol/L.
    3. Known sarkoidosis.
    4. Treament with tizzies.
    5. Primary hyperparathyroidism.
    6. Hypercalcaemia (verified by a laboratory result younger than 2 month).
    7. History of kidney stones.
    8. Hypersensivity to cholecalciferol and/or any of the excipients.
    9. Other criteria that could jeopardize the study or its intention as judged by the investigator.
    10. Not being able to perform EORTC-QLQ-BR23 or Brief Pain Inventory Short Form.
    E.5 End points
    E.5.1Primary end point(s)
    Reduced joint and muscle pain during 12 weeks of vitamin D supplementation
    E.5.1.1Timepoint(s) of evaluation of this end point
    Measurement of joint and muscle pain with Brief Pain Inventory Short Form at inclusion and after 6 and 12 weeks.
    E.5.2Secondary end point(s)
    1. Improvement in quality of life measured with EORTC-QLQ-BR23 at screening and after 6 and 12 weeks
    2. Improvement in fatigue and depression measured with patient reported Numeric score 0-10 at screening and after 6 and 12 weeks
    3. Levels of 25-OHD in serum after 12 weeks of treatment.
    4. The safety endpoint is the frequency of AE among all subjects and the levels of calcium in plasma and urine (selected patients) during the study period.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Improvement in quality of life measured with EORTC-QLQ-BR23 at screening and after 6 an 12 weeks
    2. Improvement in fatigue and depression measured with patient reported Numeric score 0-10 at screening and after 6 and 12 weeks
    3. Levels of 25-OHD in serum after 12 weeks of treatment.
    4. The safety endpoint is the frequency of AE among all subjects and the levels of calcium in plasma and urine (selected patients) during the study period at screening, at week 6 and 12.
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    Pilot study where the patient is its own control
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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.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)
    Only expected normal treatment for Vitamin D deficiency according to available guidelines.
    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 Decision2017-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-28
    P. End of Trial
    P.End of Trial StatusOngoing
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