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    Summary
    EudraCT Number:2020-004903-15
    Sponsor's Protocol Code Number:2020-004903-15
    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:2021-10-12
    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 number2020-004903-15
    A.3Full title of the trial
    Denosumab (DMAB) Discontinuation and Switching Study in Glucocorticoid-Induced Osteoporosis (GIOP): A Pilot Study
    Studio pilota sulla sospensione di denosumab e il passaggio ad altro trattamento nell’osteoporosi indotta da glucocorticoidi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    DMAB Discontinuation and Switching Study
    Discontinuazione e switch del denosumab
    A.3.2Name or abbreviated title of the trial where available
    DMAB Discontinuation and Switching Study
    Discontinuazione DMAB
    A.4.1Sponsor's protocol code number2020-004903-15
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04177940
    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 SponsorUniversity of Alabama at Birmingham
    B.1.3.4CountryUnited States
    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.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversità di Verona
    B.5.2Functional name of contact pointDavide Gatti
    B.5.3 Address:
    B.5.3.1Street AddressPz Scuro 10
    B.5.3.2Town/ cityVerona
    B.5.3.3Post code37134
    B.5.3.4CountryItaly
    B.5.6E-maildavide.gatti@univr.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.2.1.2Country 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 nameAlendronato
    D.3.2Product code [Alendronato]
    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 INNACIDO ALENDRONICO
    D.3.9.1CAS number 121268-17-5
    D.3.9.2Current sponsor codeOPR000000528
    D.3.9.3Other descriptive nameAlendronate
    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.IMP: 2
    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.2.1.2Country 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 Zoledronico
    D.3.2Product code [042337016]
    D.3.4Pharmaceutical form 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 INNACIDO ZOLEDRONICO
    D.3.9.1CAS number 118072-93-8
    D.3.9.2Current sponsor codeAcido zoledronico
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 3
    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 No
    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 nameDenosumab
    D.3.2Product code [Denosumab]
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNDENOSUMAB
    D.3.9.1CAS number 615258-40-7
    D.3.9.2Current sponsor codeDenosumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Glucocorticoid-Induced Osteoporosis (GIOP)
    Osteoporosi indotta da glucocorticoidi (GIOP)
    E.1.1.1Medical condition in easily understood language
    Osteoporosis
    Osteoporosi
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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
    To test the hypothesis that an increase in bone turnover markers (e.g. sum C-terminal telopeptide (CTX) and procollagen type 1 amino-terminal propeptide (P1NP)) in patients currently taking chronic glucocorticoids will be attenuated more in those who switch from denosumab to "late" zoledronic acid (9 months after last denosumab dose) compared to participants randomized to "early" zoledronic acid (6 months after last denosumab dose) or weekly alendronate (6 months after last denosumab dose).
    Verificare l'ipotesi che un aumento dei marker di turnover osseo (ad es. telopeptide C-terminale (CTX) e procollagene tipo 1 propeptide amminoterminale (P1NP)) nei pazienti che assumono glucocorticoidi cronici sarà attenuato maggiormente in coloro che passano da denosumab a Acido zoledronico "tardivo" (9 mesi dopo l'ultima dose di denosumab) rispetto ai partecipanti randomizzati ad acido zoledronico "precoce" (6 mesi dopo l'ultima dose di denosumab) o alendronato settimanale (6 mesi dopo l'ultima dose di denosumab).
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria:
    Women and men, age 18 years or older and able to provide informed consent (IC)
    = 3 months of glucocorticoid use at > 7.5 mg /day (prednisone equivalent dose) and anticipated to remain on glucocorticoids for at least six months
    A baseline BMD T-score of = -1.0 at the lumbar spine, total hip, or femoral neck (prior to denosumab use if prevalent user)
    - previous doses of densoumab (for prevalent users) must be continuous and not separated by interval greater than 8 months. If interval between denosumab doses is greater than 8 months, the participant is considered a new user
    Criterii di inclusione:
    Donne e uomini, di età pari o superiore a 18 anni e in grado di fornire il consenso informato (IC)
    = 3 mesi di uso di glucocorticoidi a> 7,5 mg / die (dose equivalente di prednisone) e si prevede che rimanga sui glucocorticoidi per almeno sei mesi
    Un T-score della BMD basale di = -1,0 a livello della colonna lombare, dell'anca totale o del collo del femore (prima dell'uso di denosumab se già in terapia con denosumab)
    - le precedenti dosi di densoumab (per i pazienti già in terapia con denosumab) devono essere continue e non separate da intervalli superiori a 8 mesi. Se l'intervallo tra le dosi di denosumab è maggiore di 8 mesi, il partecipante è considerato un nuovo utilizzatore
    E.4Principal exclusion criteria
    Exclusion Criteria:
    Patients with fewer than three lumbar vertebrae that could be evaluated on dual energy x-ray absorptiometry (DXA)
    No past IV bisphosphonates. Oral bisphosphonates must not have been taken in the past 2 months and for no more than 2 consecutive months of use in the past year (e.g. 8 total weekly doses of alendronate maximum)
    Greater than 24 months (>4 injections) of prior treatment with denosumab
    Women of childbearing potential, who are not currently using birth control, are pregnant, planning to become pregnant, or are breastfeeding. For women of childbearing potential: refusal to use 2 highly effective forms of contraception and to continue this practice for 7 months after last injection of study medication*
    Men planning to conceive in the next 12 months
    Unstable systemic medical condition
    Uncontrolled hyperthyroidism
    Uncontrolled hypothyroidism
    History of Addison disease
    History of osteomalacia
    History of osteonecrosis of the jaw (ONJ)
    History of atypical femur fracture
    History of tooth extraction, jaw surgery, dental implants, or other dental surgery within the prior 6 months
    History of anorexia nervosa, bulimia (by history or physical) or obvious malnutrition.
    Invasive dental work(implants/surgery) planned in the next 2 years
    History of Paget's disease of bone
    Other bone diseases which affect bone metabolism
    Vitamin D deficiency [25(OH) vitamin D level < 20 ng/mL (<49.9 nmol/L)]
    Hypercalcemia >10% above upper limit of normal (ULN)
    Elevated transaminases or total bilirubin = 2.0 x ULN
    History of any solid organ or bone marrow transplant
    Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma or localized squamous cell carcinoma of the skin)
    Hypocalcemia <10% below lower limit of normal (LLN)
    Estimated glomerular filtration rate < 30 mL/minute/1.73 m^2
    Intolerance to calcium supplements, vitamin D supplements
    Contraindication to, or poorly tolerant of denosumab therapy (including hypersensitivity to the drug)
    Contraindication to, or poorly tolerant of zoledronic therapy (including hypersensitivity to the drug)
    Contraindication to, or poorly tolerant of alendronate (including hypersensitivity to the drug and sever gastro-intestinal intolerance to oral bisphosphonates)
    Recipient of an investigational drug within 4 weeks prior to study drug administration
    Not a good candidate for study participation in opinion of investigator
    Criteri di esclusione:
    Pazienti con meno di tre vertebre lombari che potrebbero essere valutati con l'assorbimetria a raggi X a doppia energia (DXA)
    Nessun bifosfonato EV passato. I bifosfonati orali non devono essere stati assunti negli ultimi 2 mesi e per non più di 2 mesi consecutivi di utilizzo nell'ultimo anno (ad es. 8 dosi settimanali totali di alendronato massimo)
    Più di 24 mesi (> 4 iniezioni) di precedente trattamento con denosumab
    Donne in età fertile, che attualmente non usano il controllo delle nascite, sono incinte, stanno pianificando una gravidanza o stanno allattando. Per le donne in età fertile: rifiuto di utilizzare 2 forme contraccettive altamente efficaci e di continuare questa pratica per 7 mesi dopo l'ultima iniezione del farmaco in studio *
    Uomini che intendono concepire nei prossimi 12 mesi
    Condizione medica sistemica instabile
    Ipertiroidismo incontrollato
    Ipotiroidismo incontrollato
    Storia della malattia di Addison
    Storia dell'osteomalacia
    Storia dell'osteonecrosi della mascella (ONJ)
    Storia di frattura atipica del femore
    Storia di estrazione di un dente, chirurgia della mandibola, impianti dentali o altri interventi di chirurgia dentale nei 6 mesi precedenti
    Anamnesi di anoressia nervosa, bulimia (anamnestica o fisica) o palese malnutrizione.
    Interventi odontoiatrici invasivi (impianti / chirurgia) previsti nei prossimi 2 anni
    Storia della malattia ossea di Paget
    Altre malattie ossee che influenzano il metabolismo osseo
    Carenza di vitamina D [25 (OH) livello di vitamina D <20 ng / mL (<49,9 nmol / L)]
    Ipercalcemia> 10% sopra il limite superiore della norma (ULN)
    Transaminasi elevate o bilirubina totale = 2,0 x ULN
    Storia di qualsiasi trapianto di organo solido o midollo osseo
    Malignità negli ultimi 5 anni (eccetto carcinoma cervicale in situ o carcinoma a cellule basali o carcinoma a cellule squamose localizzato della pelle)
    Ipocalcemia <10% al di sotto del limite inferiore della norma (LLN)
    Velocità di filtrazione glomerulare stimata <30 mL / minuto / 1,73 m ^ 2
    Intolleranza agli integratori di calcio, integratori di vitamina D.
    Controindicazione o scarsa tolleranza alla terapia con denosumab (inclusa l'ipersensibilità al farmaco)
    Controindicazione o scarsa tolleranza alla terapia zoledronica (inclusa l'ipersensibilità al farmaco)
    Controindicazione o scarsa tolleranza all'alendronato (inclusa ipersensibilità al farmaco e severa intolleranza gastrointestinale ai bifosfonati orali)
    Destinatario di un farmaco sperimentale entro 4 settimane prima della somministrazione del farmaco in studio
    Non è un buon candidato per la partecipazione allo studio secondo l'opinione dello sperimentatore
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is log of the absolute difference in CTX values between randomization (V4) and 6 months after randomization (V6)
    L'outcome primario è il log della differenza assoluta nei valori CTX tra la randomizzazione (V4) e 6 mesi dopo la randomizzazione (V6)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary end point will be evaluated six months after randomization
    L'endpoint primario sarà valutato sei mesi dopo la randomizzazione
    E.5.2Secondary end point(s)
    Change in the log-transformed CTX between 6 months (V6) and 12 months (V7)
    Percentage change in the log-transformed CTX 12 months (V7) post randomization
    P1NP absolute change (µg/mL) 6 months (V6) post randomization
    P1NP percent change (µg/mL) 12 months (V7) post randomization
    BMD at spine absolute and percent change (g/cm2) 12 months (V7) post randomization
    BMD at total-hip absolute and percent change (g/cm2) 12 months (V7) post randomization
    BMD at femoral neck absolute and percent change (g/cm2) 12 months (V7) post randomization
    Variazione della CTX trasformata in logaritmo tra 6 mesi (V6) e 12 mesi (V7)
    Variazione percentuale nel CTX trasformato in logaritmo 12 mesi (V7) dopo la randomizzazione
    Variazione assoluta P1NP (µg / mL) 6 mesi (V6) dopo la randomizzazione
    Variazione percentuale P1NP (µg / mL) 12 mesi (V7) dopo la randomizzazione
    BMD alla colonna vertebrale assoluta e variazione percentuale (g / cm2) 12 mesi (V7) dopo la randomizzazione
    BMD all'anca totale assoluta e variazione percentuale (g / cm2) 12 mesi (V7) dopo la randomizzazione
    BMD al collo del femore assoluta e variazione percentuale (g / cm2) 12 mesi (V7) dopo la randomizzazione
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints will be evaluated between 6 and 12 months post randomization
    Gli endpoint secondari saranno valutati tra 6 e 12 mesi dopo la randomizzazione
    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 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
    Investigators will test the hypothesis that an increase in bone turnover markers (e.g. carboxy-terminal collagen crosslinks (CTX) and P1NP) in patients currently taking chronic glucocorticoids will be attenuated more in those who switch from denosumab to "late" zoledronic acid (9 months after last denosumab dose) compared to participants randomized to "early" zoledronic acid (6 months after last denosumab dose) or weekly alendronate (6 months after last denosumab dose)
    Gli investigatori verificheranno l'ipotesi che un aumento dei marker di turnover osseo CTX e P1NP nei pazienti che attualmente assumono glucocorticoidi cronici sarà attenuato maggiormente in coloro che passano da denosumab ad acido zoledronico "tardivo" (9 mesi dopo l'ultima dose di denosumab) rispetto ai partecipanti randomizzati ad acido zoledronico "precoce" (6 mesi dopo l'ultima dose di denosumab) o alendronato settimanale (6 mesi dopo l'ultima dose di denosumab)
    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 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 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 No
    E.8.2.4Number of treatment arms in the trial3
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA3
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    Belgium
    Italy
    Netherlands
    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 years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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: 50
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 50
    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)
    All patients will be referred to their primary care physician or rheumatologist/endocrinologist at the completion of the study. Based on physician estimation of fracture risk (including, but not limited to, the last visit CTX value and ongoing glucocorticoid treatment), individuals will continue an out-of-study anti-resorptive medication
    Tutti i pazienti saranno indirizzati al proprio medico di base o reumatologo / endocrinologo al termine dello studio. Sulla base della stima del medico del rischio di frattura (inclusi, ma non limitati a, il valore CTX dell'ultima visita e il trattamento con glucocorticoidi in corso), gli individui continueranno un farmaco anti-riassorbimento fuori dallo studio
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation University of Alabama at Birmingham
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation ReumaClinic
    G.4.3.4Network Country Belgium
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation University of Verona
    G.4.3.4Network Country Italy
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation NoordWest Ziekenhuisgroep
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-20
    P. End of Trial
    P.End of Trial StatusOngoing
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