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    Summary
    EudraCT Number:2018-003505-26
    Sponsor's Protocol Code Number:TOHNER/31
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-18
    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 number2018-003505-26
    A.3Full title of the trial
    Randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of treatment with Neridronate 100 mg (4 infusions over a period of 10 days) in patients with transient osteoporosis of the hip.
    Studio randomizzato, in doppio cieco, verso Placebo per valutare l'efficacia, la sicurezza e la tollerabilità del trattamento con Neridronato 100 mg (4 infusioni nell'arco di 10 giorni) in pazienti con osteoporosi transitoria dell'anca.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the efficacy, safety and tolerability of Neridronate versus Placebo in patients with transient osteoporosis of the hip.
    Studio clinico per valutare l'efficacia, la sicurezza e la tollerabilità del Neridronato verso il Placebo in pazienti con osteoporosi transitoria dell'anca.
    A.3.2Name or abbreviated title of the trial where available
    Phase III Trial of Neridronate in patients with transient osteoporosis of the hip.
    Studio di fase III del Neridronato in pazienti con osteoporosi transitoria dell'anca.
    A.4.1Sponsor's protocol code numberTOHNER/31
    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 SponsorABIOGEN PHARMA S.P.A.
    B.1.3.4CountryItaly
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPhidealive S.r.l.
    B.5.2Functional name of contact pointClinical Operation
    B.5.3 Address:
    B.5.3.1Street AddressVia Ludovico di Breme, 9
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20156
    B.5.3.4CountryItaly
    B.5.4Telephone number0245053512
    B.5.6E-mailricercaclinica@phidealive.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 NERIXIA - 100 MG CONCENTRATO PER SOLUZIONE PER INFUSIONE 2 FIALE
    D.2.1.1.2Name of the Marketing Authorisation holderABIOGEN PHARMA S.P.A.
    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 nameNerixia
    D.3.2Product code [035268022]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNERIDRONATO SODICO
    D.3.9.1CAS number 79778-41-9
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive nameNeridronic acid monosodium salt Sodium Neridronate Neridronate
    D.3.9.4EV Substance Code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Transient osteoporosis of the hip.
    Osteoporosi transitoria dell'anca.
    E.1.1.1Medical condition in easily understood language
    Transient osteoporosis of the hip.
    Osteoporosi transitoria dell'anca.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077555
    E.1.2Term Transient osteoporosis
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    PRIMARY OBJECTIVE OF EFFICACY:
    Evaluate the efficacy of treatment with Neridronate 100 mg, for 4 i.v. infusions, over a period of 10 days (i.e. at day 1, 4, 7 and 10) up to a total of 400 mg, compared to the treatment with Placebo, in the remission of spontaneous pain symptom, associated with transient osteoporosis of the hip.
    OBIETTIVO PRIMARIO DI EFFICACIA:
    Valutare l'efficacia del trattamento con Neridronato 100 mg, somministrato in 4 infusioni endovenose, per un periodo di 10 giorni (cioè al giorno 1, 4, 7 e 10) fino a un totale di 400 mg, rispetto al trattamento con Placebo, nella remissione dei sintomi del dolore spontaneo, associati a osteoporosi transitoria dell'anca.
    E.2.2Secondary objectives of the trial
    SECONDARY OBJECTIVES OF EFFICACY:
    - To assess the intensity of the pain symptomatology;
    - To assess the improvement of quality of life;
    - To assess the improvement of the functional state of the affected hip compared to baseline;
    - To assess the rescue analgesic consumption (Paracetamol);
    - To assess the safety and tolerability of Neridronate i.v. infusions;
    - To assess the effect of treatment on Body Mass Index (BMI).
    OBIETTIVO SECONDARIO DI EFFICACIA:
    - Valutare l'intensità della sintomatologia del dolore;
    - Valutare il miglioramento della qualità di vita;
    - Valutare il miglioramento dello stato funzionale dell'anca interessata rispetto al basale;
    - Valutare il consumo di Paracetamolo;
    - Valutare la sicurezza e la tollerabilità del Neridronato;
    - Valutare l'effetto del trattamento sull'indice di massa corporea (BMI).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    INCLUSION CRITERIA:
    1. Age of 18 years or older;
    2. Ability to understand study objectives and all required study procedures;
    3. Approval and signature of Informed Consent, prior to participating to the study;
    4. Women of child-bearing potential must have a negative pregnancy test prior to starting the study and use adequate anticonceptive methods (for all women who already terminated pregnancy period, it’s mandatory that they have interrupted breastfeeding time, before participation to the study);
    5. The diagnosis of transient osteoporosis of the hip will take place through the anamnestic data collection, the clinical examination, DEXA evaluation and hip bone MRI;
    6. MRI should indicate the typical pattern of transient osteoporosis of the hip, which will show an extended and homogeneous area of reduced signal in T1 sequences, and of hyperintensity in T2 images at femoral head level, with possible extension to neck level and femoral intertrochanteric region;
    7. Presence of spontaneous pain longer than 3 weeks and expressed by the patient, on the VAS scale, as equal to or greater than 50 mm.
    CRITERI DI INCLUSIONE:
    1. Età = 18 anni;
    2. Capacità di comprendere gli obiettivi dello studio e tutte le procedure richieste ai fini dello studio;
    3. Approvazione e firma del consenso informato, prima della partecipazione allo studio;
    4. Le donne in età fertile dovranno avere un test di gravidanza negativo prima di iniziare lo studio e utilizzare metodi contraccettivi adeguati (per tutte le donne che hanno concluso la gravidanza, potranno essere trattate previa interruzione dell’allattamento, prima della partecipazione allo studio);
    5. La diagnosi di osteoporosi transitoria dell'anca avverrà attraverso la raccolta anamnestica, l'esame clinico, la valutazione della DEXA e la risonanza magnetica dell'anca;
    6. La risonanza magnetica dovrà mostrare il pattern tipico di osteoporosi transitoria dell'anca coinvolta, che si presenterà con una diffusa ed omogenea area di ridotto segnale nelle sequenze T1 e di iperintensità nelle immagini T2 a livello della testa del femore, con possibile estensione al livello del collo e della regione intertrocanterica femorale;
    7. Presenza di dolore superiore alle 3 settimane ed espresso dal paziente, su scala VAS, con uno score uguale o superiore a 50 mm.
    E.4Principal exclusion criteria
    EXCLUSION CRITERIA:
    1. Subjects with age < 18 years;
    2. Severe inability to understand the study and to undergo to all necessary procedures;
    3. Refuse to provide written informed consent, prior to participating to the study;
    4. Women of childbearing potential who do not undergo pregnancy tests and do not use adequate anticonceptive methods;
    5. Women of childbearing age with a positive pregnancy test, in a pregnant or breastfeeding status;
    6. Other causes of coxalgia related to inflammatory joint diseases (rheumatoid arthritis, psoriatic or septic arthritis) or linked to stress fractures, villonodular synovitis, synovial chondromatosis;
    7. Contemporary presence of osteometabolic diseases. The coexistence of initial coxarthrosis is not an exclusion criterium, for enrollment in the study;
    8. Presence at MRI examination, of compatible alterations with aseptic osteonecrosis, with a changed profile of the articular surfaces;
    9. Other diagnosis of osteonecrosis detected by instrumental examinations;
    10. Blood calcium values, below standard parameters or a glomerular filtrate lower than 35 ml/min;
    11. Positive history and/or evocative signs or symptoms for relevant diseases, related to ongoing organ failures (hepatic, renal, endocrine, haematological, cardiac, pulmonary or neurological failures);
    12. Recent tooth extraction (in the past 3 months prior to Visit 1), unhealed or infected extraction site, significant dental/periodontal disease that may predispose to tooth extraction or other invasive dental procedures during the trial;
    13. Evidence of denture-related gum trauma or injury;
    14. Prior development of an allergic reaction/hypersensitivity to bisphosphonates;
    15. Current treatment with bisphosphonates or in the previous 12 months;
    16. Patient who received any new investigational drug within the last 12 weeks.
    CRITERI DI ESCLUSIONE:

    1. Soggetti con età <18 anni;
    2. Grave incapacità di comprendere gli obiettivi dello studio e tutte le procedure richieste ai fini dello studio;
    3. Rifiuto di fornire il consenso informato scritto, prima di partecipare allo studio;
    4. Donne in età fertile che non si sottopongono a test di gravidanza e non usano metodi contraccettivi adeguati;
    5. Donne in età fertile positive al test di gravidanza o in fase di allattamento;
    6. Altre cause di coxalgia correlate a malattie infiammatorie articolari (artrite reumatoide, artrite psoriasica o settica) o legate a fratture da stress, sinovite villonodulare, condromatosi sinoviale;
    7. Contemporanea presenza di patologie osteometaboliche. La coesistenza della coxartrosi iniziale non è un criterio di esclusione;
    8. Presenza alla RMN, di alterazioni compatibili con un focolaio di osteonecrosi asettica, con un alterato profilo delle superfici articolari;
    9. Altre diagnosi di osteonecrosi rilevate da esami strumentali;
    10. Valori di calcemia, al di sotto dei parametri standard o un filtrato glomerulare inferiore a 35 ml/min;
    11. Anamnesi positiva e/o segni o sintomi evocativi per rilevanti patologie, correlate ad insufficienza d’organo (insufficienza epatica, renale, endocrina, ematologica, cardiaca, polmonare o neurologica);
    12. Estrazione dentale recente (negli ultimi 3 mesi precedenti alla Visita 1), sito di estrazione non ancora cicatrizzato o infetto, malattia dentale/periodontale significativa che può predisporre all'estrazione del dente o ad altre procedure dentali invasive durante lo studio;
    13. Presenza di traumi o lesioni alle gengive dovuti a protesi dentarie;
    14. Precedente sviluppo di una reazione allergica/ipersensibilità ai bisfosfonati;
    15. Trattamento attuale o nei 12 mesi precedenti con bifosfonati;
    16. Paziente che ha ricevuto nuovi farmaci sperimentali nelle ultime 12 settimane.
    E.5 End points
    E.5.1Primary end point(s)
    PRIMARY END POINTS:
    Reduction = 50% in spontaneous pain on a visual-analog scale of Huskisson (VAS) of 100 mm (0= no pain; 100= strong pain), from baseline (Visit 2) to the last visit of the double-blind randomized phase (Visit 6).
    END-POINTS PRIMARIO:
    Riduzione del dolore spontaneo = 50% su una scala visuo-analogica di Huskisson (VAS) di 100 mm (0 = nessun dolore, 100 = dolore forte), a distanza di 30 giorni dalla prima infusione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days after the first infusion.
    A distanza di 30 giorni dalla prima infusione.
    E.5.2Secondary end point(s)
    SECONDARY END POINTS:
    - Measurements of the intensity of the pain symptomatology on a VAS scale of 100 mm, will be also recorded at V2, V3, V4, V5, V7/V7A, V7B, V7C, V7D, V7E, V8/V8A;
    - Measurements of the intensity of pain symptoms, expressed through the score, derived from the Short-Form McGill Pain questionnaire, will be evaluated at V2, V6, V7/V7A, V7E, V8/V8A, V9;
    - Improvement of quality of life, by SF-36 questionnaire, will be evaluated at V2, V6, V7/V7A, V7E, V8/V8A, V9;
    - Change of the functional state of the affected hip, by WOMAC questionnaire, will be evaluated at V2, V6, V7/V7A, V7E, V8/V8A, V9;
    - Paracetamol use will be evaluated from V2 to V6 in double blind phase (for all patients) and from V6 to V7E in the open label phase (applicable only for patients who will take Neridronate, in open label phase); in case of discontinuation, until subject remains in the study;
    - Body Mass Index (BMI) will be evaluated at V1, V7/V7A, V8/V8A, V9.
    END-POINTS SECONDARI:
    - L’intensità della sintomatologia dolorosa misurazione, su una scala VAS di 100 mm, sarà anche registrata a V2, V3, V4, V5, V7/V7A, V7B, V7C, V7D, V7E, V8/V8A;
    - La misura della variazione della sintomatologia dolorosa espressa tramite lo score derivato dal questionario Short-Form McGill Pain, sarà valutata a V2, V6, V7/V7A, V7E, V8/V8A, V9;
    - Il miglioramento della qualità della vita, tramite il questionario SF-36, sarà valutato a V2, V6, V7/V7A, V7E, V8/V8A, V9;
    - Variazione dello stato funzionale dell'anca interessata, sarà valutato dal questionario WOMAC, a V2, V6, V7/V7A, V7E, V8/V8A, V9;
    - L'uso di Paracetamolo sarà valutato da V2 sino a V6 nella fase doppio cieco (per tutti i pazienti) e da V6 a V7E nella fase in aperto (per i pazienti che accetteranno il trattamento con Neridronato, nella fase in aperto); o in caso di interruzione, fino a quando il soggetto rimarrà nello studio;
    - L'indice di massa corporea (BMI) sarà valutato a V1, V7/V7A, V8/V8A, V9.
    E.5.2.1Timepoint(s) of evaluation of this end point
    see section E.5.2
    vedi sezione E.5.2
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilità
    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) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    fase di estensione in aperto
    open label phase extension
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 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 years0
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months30
    E.8.9.2In all countries concerned by the trial days0
    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: 30
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    -
    -
    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 Decision2019-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-19
    P. End of Trial
    P.End of Trial StatusOngoing
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