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    Summary
    EudraCT Number:2020-005343-23
    Sponsor's Protocol Code Number:ADAIDO
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    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 number2020-005343-23
    A.3Full title of the trial
    Effect of the antiresorptive treatment with alendronate versus no treatment after denosumab and aromatase inhibitors discontinuation in low fracture risk osteopenic postmenopausal women with non metastatic hormonal receptor positive breast cancer (the ADAIDO study, Alendronate after Denosumab and Aromatase Inhibitors Discontinuation in Osteopenic women with breast cancer).
    Effetto del trattamento anti-riassorbimento con alendronato rispetto a nessun trattamento dopo l’interruzione della terapia con denosumab e inibitori dell’aromatasi in donne a basso rischio di frattura osteopeniche in post-menopausa affette da carcinoma mammario non metastatico positivo al recettore ormonale (studio ADAIDO).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the antiresorptive treatment with alendronate versus no treatment after denosumab and aromatase inhibitors discontinuation in low fracture risk osteopenic postmenopausal women with non metastatic hormonal receptor positive breast cancer.
    Studio del trattamento anti-riassorbimento con alendronato rispetto a nessun trattamento dopo l’interruzione della terapia con denosumab e inibitori dell’aromatasi in donne a basso rischio di frattura osteopeniche in post-menopausa affette da carcinoma mammario non metastatico positivo al recettore ormonale.
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberADAIDO
    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 SponsorIRCCS ISTITUTO ORTOPEDICO GALEAZZI S.P.A
    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 supportAmgen
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportAbiogen Pharma S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOPIS s.r.l.
    B.5.2Functional name of contact pointDipartimento Medico
    B.5.3 Address:
    B.5.3.1Street AddressPalazzo Aliprandi - Via Matteotti, 10
    B.5.3.2Town/ cityDesio (MB)
    B.5.3.3Post code20832
    B.5.3.4CountryItaly
    B.5.4Telephone number003903626331
    B.5.5Fax number003903626331
    B.5.6E-mailinfo.studiclinici@opis.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 BINOSTO - 70 MG COMPRESSE EFFERVESCENTI
    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 nameAcido Alendronico
    D.3.2Product code [Binosto]
    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 INNACIDO ALENDRONICO
    D.3.9.1CAS number 121268-17-5
    D.3.9.2Current sponsor codeBinosto
    D.3.9.3Other descriptive name-
    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 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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    post-menopausal osteoporosis in women with non-metastatic hormonal receptor positive (HR+) breast cancer.
    osteoporosi post-menopausale in donne affette da carcinoma mammario non metastatico positivo per il recettore ormonale (HR+).
    E.1.1.1Medical condition in easily understood language
    post-menopausal osteoporosis in women with non-metastatic hormonal receptor positive (HR+) breast cancer.
    osteoporosi post-menopausale in donne affette da carcinoma mammario non metastatico positivo per il recettore ormonale (HR+)
    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 PT
    E.1.2Classification code 10049088
    E.1.2Term Osteopenia
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective 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 the effect of alendronate versus no treatment on bone mineral density (BMD) in the following 12 months after the denosumab and aromatase inhibitors (AI) discontinuation in low fracture risk (defined as a10-years predicted fracture risk < 20% for major osteoporotic fractures and < 3% for femur fractures according the FRAX algorithm) osteopenic women with post-menopausal non-metastatic hormonal receptor positive (HR+) breast cancer.
    Valutare l’effetto di alendronato rispetto a nessun trattamento sulla densità minerale ossea (Bone Mineral Density – BMD) nei 12 mesi successivi all’interruzione della terapia con denosumab e inibitori dell’aromatasi (Aromatase Inhibitors – AI) in donne a basso rischio di frattura (definito come un rischio previsto di frattura a 10 anni < 20% per fratture osteoporotiche maggiori e < 3% per fratture al femore secondo l’algoritmo FRAX) osteopeniche affette da carcinoma mammario post-menopausa non metastatico positivo per il recettore ormonale (HR+).
    E.2.2Secondary objectives of the trial
    In low fracture risk osteopenic women with post-menopausal non-metastatic hormonal receptor positive (HR+) breast cancer, to evaluate the effect of alendronate versus no treatment:
    1. on the turnover biomarkers in the following 3, 12 and 24 months after the denosumab and aromatase inhibitors (AI) discontinuation
    2. on bone mineral density (BMD) at the end of 24 months of follow up after the denosumab and aromatase inhibitors (AI) discontinuation
    3. on vertebral and non-vertebral fractures in the following two years after the denosumab and AI discontinuation
    4. on morphometric vertebral fractures in the following 12 and 24 months after the denosumab and AI discontinuation in low fracture risk osteopenic women with post-menopausal breast cancer.
    5. To monitor the adverse events/clinical in treated and untreated patients.
    In donne a basso rischio di frattura osteopeniche affette da carcinoma mammario post-menopausa non metastatico positivo per il recettore ormonale (HR+), valutare l’effetto di alendronato rispetto a nessun trattamento:
    1. sui biomarker di turnover nei 3, 12 e 24 mesi successivi all’interruzione della terapia con denosumab e inibitori dell’aromatasi (AI)
    2. sulla densità minerale ossea (BMD) al termine di 24 mesi di follow-up dopo l’interruzione della terapia con denosumab AI
    3. sulle fratture vertebrali e non vertebrali nei due anni successivi all’interruzione della terapia con denosumab e AI
    4. sulle fratture vertebrali morfometriche nei 12 e 24 mesi successivi all’interruzione della terapia con denosumab e AI in donne a basso rischio di frattura osteopeniche affette da carcinoma mammario post-menopausa
    5. Monitorare gli eventi avversi/clinici nelle pazienti trattate e non trattate.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient who have signed and dated the informed consent form approved by EC, before undergoing any study-specific procedure;
    - Postmenopausal women (absence of spontaneous menstrual cycle for at least 12 months);
    - Treated for breast cancer with AI (letrozole, anastrozole, examestane) for at least two years;
    - Denosumab stopped at least 4 months before ICF signature, after at least 2 year treatment duration to prevent/treat the CTIBL (in primary prevention);
    - Affected with osteopenia, diagnosed as femoral T-scores by DXA performed within the last 36 months from the AI discontinuation, within the range -1.0 to -2.4 (WHO criteria for diagnosis of osteoporosis)[16],
    - with low risk fracture, defined as a 10-years predicted fracture risk < 20% for major osteoporotic fractures and < 3% for femur fractures according the FRAX algorithm (http://www.shef.ac.uk/FRAX/)
    - Stopping AI treatment within the 6 months from the last denosumab administration [14]
    - Current supplementation with calcium and vitamin D (according clinical routine practice).
    - Pazienti che hanno firmato e datato il modulo di consenso informato approvato dal Comitato Etico prima di sottoporsi a qualsiasi procedura studio specifica;
    - Donne in post-menopausa (assenza di ciclo mestruale spontaneo per almeno 12 mesi):
    - Pazienti trattate per carcinoma mammario con AI (letrozolo, anastrozolo, examestane) per almeno due anni;
    - Interruzione di denosumab almeno 4 mesi prima della firma del consenso informato, dopo almeno 2 anni di trattamento per prevenire/trattare la CTIBL (in prevenzione primaria);
    - Pazienti affette da osteopenia, diagnosticata come punteggi T femorali tramite DXA effettuata entro i 36 mesi precedenti dall’interruzione di AI, entro il range da -1.0 a -2.4 (criteri WHO per la diagnosi di osteoporosi);
    - Pazienti a basso rischio di frattura, definite come un rischio previsto di frattura a 10 anni < 20% per fratture osteoporotiche maggiori e < 3% per fratture femorali in base all’algoritmo FRAX (http://www.shef.ac.uk/FRAX/)
    - Pazienti che hanno interrotto il trattamento con AI entro 6 mesi dall’ultima somministrazione di denosumab;
    - Attuale integrazione con calcio e vitamina D (in accordo alla pratica clinica di routine).
    E.4Principal exclusion criteria
    - Age > 75 years;
    - BMI < 20 e > 35 kg/m2;
    - Osteoporosis diagnosed as femoral T-score by DXA ¿ -2.5 (test performed as routine)
    - Clinical or morphometric fractures detected by thoracic and lumbar Rx
    - Recent invasive dental surgery with no complete healing at moment of inclusion
    - Type 1 diabetes mellitus;
    - Poorly controlled type 2 diabetes mellitus (HbA1c >7.5%, 58 mmol/mol);
    - Rheumatoid arthritis;
    - Current steroid or immunosuppressive therapies;
    - Active endocrinopathies (except hypothyroidism with good hormonal balance);
    -Chronic alcoholism
    - Chronic kidney disease stages 4-5 according to CKD-EPI (eGFR < 30 ml/min) (test performed as routine);
    - Hepatic cirrhosis, HCV and HBV-related chronic hepatitis, autoimmune hepatitis (autodeclaration);
    - Previous treatments with amino-bisphosphonates (except previous treatment with clodronate);
    - Known history of reflux esophagitis.
    - Other known contraindications to bisphosphonates
    - Età > 75 anni;
    - BMI compreso tra < 20 e > 35 kg/m2;
    - Osteoporosi diagnosticata tramite punteggio T femorale tramite DXA ¿ -2.5 (test effettuato di routine);
    - Fratture cliniche o morfometriche rilevate tramite Rx toracica e lombare;
    - Recente chirurgia dentale invasiva senza guarigione completa al momento dell’inclusione;
    - Diabete mellito di Tipo 1;
    - Diabete mellito di Tipo 2 scarsamente controllato (HbA1c >7.5%, 58 mmol/mol);
    - Artrite reumatoide;
    - Attuali terapie con steroidi o terapie immunosuppressive;
    - Endocrinopatie attive (ad eccezione di ipotiroidismo con buon equilibrio ormonale);
    - Alcolismo cronico;
    - Malattia renale cronica di stadio 4-5 in base a CKD-EPI (eGFR < 30 ml/min) (test effettuato di routine);
    - Cirrosi epatica, epatite cronica correlata a HCV e HBV, epatite autoimmune (autodichiarazione);
    - Trattamento pregresso con amino-bifosfonati (ad eccezione di trattamento pregresso con clodronato);
    - Storia nota di esofagite da reflusso;
    - Altre controindicazioni note ai bifosfonati.
    E.5 End points
    E.5.1Primary end point(s)
    Percent changes in BMD measured at lumbar and femoral sites at 12 months with respect to basal conditions
    Variazioni percentuali della densità minerale ossea (Bone Mineral Density – BMD) misurata sia al sito femorale che lombare a 12 mesi rispetto alle condizioni basali
    E.5.1.1Timepoint(s) of evaluation of this end point
    Basal assessment (time 0) and 12 months
    Valutazione basale (tempo 0) e 12 mesi
    E.5.2Secondary end point(s)
    1. changes in serum bone-specific alkaline phosphatase activity, CTX, P1NP and FGF23 at 3, 12 and 24 months with respect to basal levels;
    2. changes in BMD measured at lumbar and femoral sites at 24 months with respect to basal conditions;
    3. occurrence of new fragility fractures at any sites anamnestically recorded at 3, 12 and 24 months visits;
    4. detection of new morphometric vertebral fractures by thoracic and lumbar Rx at 12 and 24 months of follow up;
    5. incidence of the adverse events/clinical and morphometric fractures in treated and untreated patients
    1. Variazioni sieriche nell’attività della fosfatasi alcalina specifica per le ossa, CTX, P1NP e dosaggio di FGF23 a 3, 12 e 24 mesi rispetto ai livelli basali;
    2. Variazioni percentuali della densità minerale ossea (Bone Mineral Density – BMD) misurata sia al sito femorale che lombare a 24 mesi rispetto alle condizioni basali;
    3. Rilevamento di nuove fratture da fragilità in qualsiasi sito documentate con anamnesi alle visite a 3, 12 e 24 mesi;
    4. Rilevamento di nuove fratture vertebrali morfometriche tramite Rx toracica e lombare a 12 e 24 mesi di follow-up;
    5. Incidenza degli eventi avversi / fratture cliniche e morfometriche nelle pazienti trattate e non trattate.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Basal assessment (time 0), 3, 12 and 24 months
    2. Basal assessment (time 0) and 24 months
    3. 3, 12 and 24 months
    4. 12 and 24 months
    5 . Up to 24 months
    1. Valutazione basale (tempo 0), 3, 12, 24 mesi
    2. Valutazione basale (tempo 0) e 24 mesi
    3. 3, 12, 24 mesi
    4. 12 e 24 mesi
    5. Fino a 24 mesi
    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 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) 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 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
    Pazienti senza trattamento
    no treatment arm
    E.8.2.4Number of treatment arms in the trial2
    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 concerned9
    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 years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state190
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 190
    F.4.2.2In the whole clinical trial 190
    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)
    no treatment
    Nessun trattamento
    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 Decision2021-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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