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    Summary
    EudraCT Number:2016-000481-32
    Sponsor's Protocol Code Number:THYPOS
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-000481-32
    A.3Full title of the trial
    TERIPARATIDE FOR THE PRIMARY PREVENTION OF POST-SURGICAL HYPOCALCEMIA
    TERIPARATIDE FOR THE PRIMARY PREVENTION OF POST-SURGICAL HYPOCALCEMIA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    USE OF TERIPARATIDE TO PREVENT HYPOCALCEMIA IN POST SURGICAL PATIENTS
    USO DELLA TERIPARATIDE PER PREVENIRE IPOCALCEMIA POST-CHIRURGICA
    A.3.2Name or abbreviated title of the trial where available
    THYPOS
    THYPOS
    A.4.1Sponsor's protocol code numberTHYPOS
    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 SponsorUNIVERSITÀ CAMPUS BIO-MEDICO DI ROMA
    B.1.3.4CountryItaly
    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 supportUNIVERSITA' CAMPUS BIO-MEDICO DI ROMA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNIVERSITA' CAMPUS BIO-MEDICO DI ROMA
    B.5.2Functional name of contact pointUNITA DI RICERCA DI ENDOCRINOLOGIA
    B.5.3 Address:
    B.5.3.1Street AddressVIA ALVARO DEL PORTILLO 21
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00128
    B.5.3.4CountryItaly
    B.5.4Telephone number06225419184
    B.5.5Fax number06225419721
    B.5.6E-maila.palermo@unicampus.it
    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 FORSTEO - 20 MCG/80 MCL SOLUZIONE INIETTABILE IN PENNA PREMPITA 3 ML 1 PENNA USO SOTTOCUTANEO
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY NEDERLAND BV
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.1Product nameFORSTEO
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTERIPARATIDE
    D.3.9.1CAS number 52232-67-4
    D.3.9.2Current sponsor coden.a.
    D.3.9.3Other descriptive nameTERIPARATIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    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
    POST SURGICAL HYPOCALCEMIA
    IPOCALCEMIA POST CHIRURGICA
    E.1.1.1Medical condition in easily understood language
    patients with high risk of hypocalcemia after thyroid surgery.
    PAZIENTI SOTTOPOSTI A INTERVENTO DI TIROIDECTOMIA TOTALE CON ALTO RISCHIO DI SVILUPPARE IPOCALCEMIA POST-CHIRURGICA
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10033557
    E.1.2Term Palpitations
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10021097
    E.1.2Term Hypotension
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10037087
    E.1.2Term Pruritus
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to evaluate if teriparatide is able to prevent post-surgical hypocalcemia in subjects with high risk of hypocalcemia after thyroid surgery.
    VALUTARE SE LA TERIPARATIDE E' IN GRADO DI PREVENIRE LO SVILUPPO DI IPOCALCEMIA POST CHIRURGICA
    E.2.2Secondary objectives of the trial
    N.A.
    N.A.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    surgical indication for thyroidectomy
    PAZIENTI CON INDICAZIONE AD INTERVENTO DI TIROIDECTOMIA TOTALE
    E.4Principal exclusion criteria
    -Age younger than 18 years
    - Pregnancy
    - Renal failure (glomerular filtration rate < 30 mL/min)
    - Hypersensitivity to the active substance or excipients
    - Any prior parathyroid pathology
    - Familiar history of Osteosarcoma or any other bone tumors
    - Preexisting hypercalcemia
    - Symptomatic orthostatic hypotension
    - Metabolic bone disease other than osteoporosis
    - Ongoing teriparatide therapy for osteoporosis
    - History of skeletal malignancies (primary or metastatic)
    - Treatment with digoxin (digitalis therapy)
    - Active or recent urolithiasis
    - Unexplained elevation of serum alkaline phosphatase levels
    - Prior radiation therapy involving the skeleton
    -ETA' MINORE DI 18 ANNI
    -GRAVIDANZA
    -INSUFFICIENZA RENALE (GRF< 30 mL/min)
    -IPERSENSIBILITA' AL PRINCIPIO ATTIVO O AGLI ECCIPIENTI
    -PATOLOGIE PARATIROIDEE PREGRESSE
    -STORIA FAMILIARE DI OSTEOSARCOMA O ALTRO TUMORE DELLE OSSA
    -PREGRESSA IPERCALCEMIA
    -IPOTENSIONE ORTOSTATICA SINTOMATICA
    -MALATTIE METABOLICHE OSSEE AD ECCEZIONE DELL'OSTEOPOROSI
    -TERAPIA IN ATTO CON TERIPARATIDE PER OSTEOPOROSI
    - STORIA DI MALATTIE MALIGNE OSSEE (PRIMITIVE O METASTATICHE)
    -TRATTAMENTO CON DIGOSSINA (TERAPIA DIGITALE)
    -RECENTE UROLITIASI
    -INSPIEGABILE INNALZAMENTO DEI VALORI SIERICI DI FOSFATASI ALCALINA
    - RADIOTERAPIA CON INTERESSAMENTO DELLO SCHELETRO
    E.5 End points
    E.5.1Primary end point(s)
    Change in calcium levels from the enrollment to the discharge
    Monitoraggio dei livelli di calcio dall'arruolamento alla dimissione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    every 12 hours till to discharge
    ogni 12 ore fino alla dimissione
    E.5.2Secondary end point(s)
    reduction of duration of the hospitalization
    riduzione dei tempi di ospedalizzazione
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the discharge
    alla dimissione
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    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 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 Yes
    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
    sorveglianza medica
    monitoring
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 Information not present in EudraCT
    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
    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 months12
    E.8.9.1In the Member State concerned days36
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months12
    E.8.9.2In all countries concerned by the trial days36
    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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 26
    F.4.2.2In the whole clinical trial 26
    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)
    STANDARD OF CARE
    STANDARD OF CARE
    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 Decision2016-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-03
    P. End of Trial
    P.End of Trial StatusCompleted
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