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    Summary
    EudraCT Number:2011-002370-23
    Sponsor's Protocol Code Number:CL2-12911-039
    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:2011-12-28
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-002370-23
    A.3Full title of the trial
    A double-blind, multicenter, international randomised study to assess the effects of 4 month-oral administration of 2g per day of strontium ranelate versus placebo on the bone quality and remodelling, as assessed on an alveolar bone biopsy extracted before dental implantation, in osteoporotic patients or in patients at risk of osteoporotic fracture.
    Studio multicentrico, internazionale, randomizzato in doppio cieco per valutare gli effetti di 4 mesi di somministrazione orale di 2 g al giorno di ranelato di stronzio verso placebo sulla qualita' dell'osso e sul rimodellamento dell'osso alveolare, valutato tramite biopsia estratta prima di un impianto dentario, in pazienti con osteoporosi o a rischio di frattura osteoporotica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of strontium ranelate on bone quality before dental implantation.
    Effetti del ranelato di stronzio sulla qualita' dell'osso prima dell'impianto dentario.
    A.4.1Sponsor's protocol code numberCL2-12911-039
    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 SponsorINSTITUT DE RECHERCHES INTERNATIONALES SERVIER
    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 supportADIR
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISTITUTO DI RICERCA SERVIER srl
    B.5.2Functional name of contact pointPROJECT MANAGER - ALESSANDRA MINASI
    B.5.3 Address:
    B.5.3.1Street AddressVIA LUCA PASSI, 85
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00166
    B.5.3.4CountryItaly
    B.5.4Telephone number06 669081
    B.5.5Fax number06 66908738
    B.5.6E-mailinfoirs@netgrs.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 PROTELOS
    D.2.1.1.2Name of the Marketing Authorisation holderLes Laboratoires Servier
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Granules for oral suspension
    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 INNSTRONTIUM RANELATE
    D.3.9.1CAS number 135459-87-9
    D.3.9.2Current sponsor codeS12911
    D.3.9.4EV Substance CodeSUB20045
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGranules for oral suspension
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dental implantation in osteoporotic patients or in patients at risk of osteoporotic fracture.
    Impianto dentario in pazienti osteoporotici o in pazienti a rischio di fratture osteoporotiche.
    E.1.1.1Medical condition in easily understood language
    Dental implantation
    Impianto dentario
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10042613
    E.1.2Term Surgical and medical procedures
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10064143
    E.1.2Term Dental implantation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of 4 month treatment with strontium ranelate in comparison with placebo on alveolar bone quality and alveolar bone turnover on alveolar biopsies
    Valutare gli effetti del trattamento con ranelato di stronzio per 4 mesi in confronto con placebo sulla qualità e sul ricambio dell'osso alveolare a seguito di biopsia alveolare
    E.2.2Secondary objectives of the trial
    To assess the effect of 4 month treatment with strontium ranelate on: -alveolar bone microarchitecture, - alveolar bone texture. To assess biological and clinical safety over 6 months. Implant stability will be assessed after 6 months of treatment
    Valutare gli effetti del trattamento con ranelato di stronzio per 4 mesi su: - microarchitettura dell'osso alveolare, - tessuto dell'osso alveolare. Valutazione della sicurezza clinica e biologica per 6 mesi. Valutazione della stabilità dell'impianto dopo 6 mesi di trattamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Men or post-menopausal women, > or = 50 years, Osteoporotic patient or with a risk of osteoporotic fracture, Eligible for a premolar extraction followed by a dental implant placement, Without inter-radicular septum at extraction.
    Uomini o donne in post-menopausa, di età &gt; o = 50 anni, pazienti osteoporotici o a rischio di frattura osteoporotica, con indicazione per l' estrazione di un premolare seguita da impianto dentale, assenza di setto intra-radicolare all'estrazione.
    E.4Principal exclusion criteria
    -Pathological findings in the jaw bone, -History of maxillar or cervico-facial irradiation, -Chronic inflammatory rheumatoid disease, -Inflammatory or metabolic bone disease,excluding osteoporosis, -Hypersensitivity to the active substances or to any of the excipients or to tetracycline.
    -Riscontri patologici nella mascella, -Storia di irradiazioni mascellari o cervico-facciali, -Patologia reumatoide infiammatoria cronica, -Patologia infiammatoria o metabolica dell'osso, esclusa l'osteoporosi, -Ipersensibilità verso le sostanze attive, gli eccipienti e le tetracicline.
    E.5 End points
    E.5.1Primary end point(s)
    - Evaluation of the efficacy by assessing alveolar bone quality and alveolar bone turnover
    - Valutazione dell'efficacia attraverso la misurazione della qualità e del ricambio dell’osso alveolare
    E.5.1.1Timepoint(s) of evaluation of this end point
    -Alveolar bone quality will be assessed by nanoindentation at M004 - Alveolar bone turnover will be assessed by histomorphometry at M004
    -La qualità dell’osso alveolare sarà valutata mediante nanoindentazione a M004, -Il ricambio dell’osso alveolare sarà valutata mediante istomorfometria a M004
    E.5.2Secondary end point(s)
    - Other parameters will be assessed by histomorphometry: resorption, microarchitecture, bone microarchitecture, texture analysis and implant stability - Safety will be assessed by: collection of adverse events, biological parameters evaluation, clinical examination
    Altri parametri saranno valutati mediante istomorfometria: riassorbimento, microarchitettura, microarchitettura ossea, analisi dei tessuti e stabilità dell'impianto - La sicurezza sarà valutata mediante: raccolta di eventi avversi, valutazione dei parametri biologici, valutazione clinica
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Resorption, microarchitecture and bone microarchitecture will be assessed at M004 - Texture analysis will be assessed at M000 and M004 - Implant stability will be assessed at M006 - Safety measurements over 6 months.
    - Il riassorbimento, la microarchitettura e la microarchitettura ossea saranno valutati alla visita M004 - L'analisi dei tessuti sarà valutata alle visite M000 e M004 - La stabilità dell'impianto sarà valutata alla visita M006 - Le valutazioni di sicurezza durante 6 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 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 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 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 No
    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 No
    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 EEA7
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    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 as stated in the protocol
    LVLS come previsto dal protocollo
    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 months31
    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 months31
    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.1.1Number of subjects for this age range: 0
    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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    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)
    After the discontinuation of the study treatment, the participant will receive a treatment and/or have access to other appropriate care by his doctor
    Dopo l'interruzione del trattamento in studio, il partecipante riceverà un trattamento e/o avrà accesso ad altre cure appropriate da parte del suo medico
    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 Decision2011-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-05-16
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