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    Summary
    EudraCT Number:2020-005040-35
    Sponsor's Protocol Code Number:0120
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-12-03
    Trial results View 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 ConcernedDenmark - DHMA
    A.2EudraCT number2020-005040-35
    A.3Full title of the trial
    The effect of effervescent and buffered alendronate on bone turnover compared to conventional alendronate: A randomized non-inferiority trial
    Effekten af Binosto® på knogleomsætningen –et non-inferiority studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of effervescent alendronate on bone turnover
    Effekten af Binosto® på knogleomsætningen
    A.4.1Sponsor's protocol code number0120
    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 SponsorAarhus University Hospital
    B.1.3.4CountryDenmark
    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 supportPharmaPrim
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus University Hospital
    B.5.2Functional name of contact pointDept. of Endocrinology
    B.5.3 Address:
    B.5.3.1Street AddressPalle Juul-Jensens Boulevard 99
    B.5.3.2Town/ cityAarhus N
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.4Telephone number004578455470
    B.5.6E-mailbentlang@rm.dk
    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 Binosto
    D.2.1.1.2Name of the Marketing Authorisation holderPharmaPrim
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Effervescent tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAlendronate
    D.3.9.3Other descriptive nameALENDRONATE SODIUM TRIHYDRATE
    D.3.9.4EV Substance CodeSUB25549
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Fosamax
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme BV
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAlendronate
    D.3.9.3Other descriptive nameALENDRONATE SODIUM TRIHYDRATE
    D.3.9.4EV Substance CodeSUB25549
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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
    Osteopenia, i.e. bone mineral density T-score < -1
    E.1.1.1Medical condition in easily understood language
    Low bone mass
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10005991
    E.1.2Term Bone mass decreased
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate if Binosto decreases bone resorption to the same extent as Fosamax
    At undersøge om Binosto sænker knoglenedbrydningen i samme grad som Fosamax
    E.2.2Secondary objectives of the trial
    To investigate:
    - If Binosto decreases bone turnoverformation to the same extent as Fosamax
    - The rate of decrease in bone turnover between the two IMPs
    - Difference in AEs between the two IMPs
    At undersøge:
    - Om Binosto sænker knogleformationen i samme grad som Fosamax
    - Hastigheden hvormed knogleomsætninen falder mellem de to lægemidler
    - Forskellen i bivirkninger mellem de to lægemidler
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Sixty-four postmenopausal women with BMD T-score < -1 osteopenia and high bone turnover.
    - 2 years since last menstrual bleeding
    - Bone mineral density T-score < -1 at either lumbar spine or hip
    - CTx > 0.42 µg/L
    64 postmenopauselle kvinder med høj knogleomsætning-
    - 2 år siden sidste menstruation
    - BMD T-score < -1 i lænd eller hofte
    - CTx > 0.42
    E.4Principal exclusion criteria
    - Ever treatment for osteoporosis
    - Indication for teriparatide treatment
    - Treatment with oral systemic glucocorticoids within last 12 months
    - Rheumatoid arthritis
    - Inflammatory bowel disease
    - Untreated thyroid disease
    - Primary hyperparathyroidism
    - Diabetes mellitus
    - eGFR < 60 mL/min
    - Cancer within last 2 years except basal cell carcinoma of the skin
    - Hormone therapy
    - Unstable liver disease
    - Contraindications for alendronate
    - Major gastrointestinal disease within 12 months (eg. esophagitis, ulcer, major surgery).
    - Vitamin D < 50nmol/L
    - Tidligere behandling for osteoporose
    - Indikation for teriparatidbehandling
    - Behandling med systemiske glukokortikoider indenfor de sidste 12 mdr
    - Reumatoid arthritis
    - Inflammatorisk tarmsygdom
    - Ubehandlet thyroideasygdom
    - Primær hyperparatyroidisme
    - Diabetes Mellitus
    - eGFR < 60mL/min
    - Cancer indenfor de sidste 2 år rfaset basalcellkarcinom i huden
    - Hormonbehandling
    - Ukontrolleret leversygdom
    - Kontraindikationer mod alendronat
    - Større gastrointestinal sygdom indenfor de sidste 12 mdr (fx esofagit, ulcus, stor kirurgi)
    - Vitamin D < 50 nmol/L
    E.5 End points
    E.5.1Primary end point(s)
    - Percent change in CTx from baseline to end of study
    - Procentvis ændring i CTx fra baseline til slutningen af studiet
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 16 weeks of treatment
    Efter 16 ugers behandling
    E.5.2Secondary end point(s)
    - Percent change in P1NP from baseline to end of study
    - Differences in rate of decline of CTx and P1NP between treatment groups
    - Adverse events (AEs)
    - Serious adverse events (SAEs)
    - Persistence (tablet count)
    - Procentvis ændring i P1NP fra baseline til slutningen af studiet
    - Forskelle i hastighed mellem behandlingsgrupperne hvormed CTx og P1NP falder
    - Bivirkninger
    - Alvorlige bivirkninger
    - Compliance (optælling af tabletter)
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 16 weeks
    Efter 16 uger
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 years1
    E.8.9.1In the Member State concerned months6
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state64
    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)
    None
    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 Decision2021-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-08-24
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