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    Summary
    EudraCT Number:2012-003131-28
    Sponsor's Protocol Code Number:IP-2012-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-10-29
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2012-003131-28
    A.3Full title of the trial
    Switching from Oral Bisphosphonates to Bazedoxifene once a day to evaluate effects on BMD in Postmenopausal Women.
    Evaluación de los efectos en la DMO en mujeres posmenopáusicas tras el cambio de bifosfonatos orales a Bazedoxifeno
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Switching from Oral Bisphosphonates to Bazedoxifene once a day to evaluate effects on BMD in Postmenopausal Women.
    Evaluación de los efectos en la DMO en mujeres posmenopáusicas tras el cambio de bifosfonatos orales a Bazedoxifeno
    A.3.2Name or abbreviated title of the trial where available
    Switching BI to BA
    cambio de bifosfonatos orales a Bazedoxifeno
    A.4.1Sponsor's protocol code numberIP-2012-01
    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 SponsorInstituto Palacios
    B.1.3.4CountrySpain
    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 supportPfizer INC
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTFS
    B.5.2Functional name of contact pointBegoña Navarro
    B.5.3 Address:
    B.5.3.1Street Addressconsell de cent, 334
    B.5.3.2Town/ citybarcelona
    B.5.3.3Post code08009
    B.5.3.4CountrySpain
    B.5.4Telephone number0034914909584
    B.5.5Fax number0034914909722
    B.5.6E-mailbegona.navarro@tfscro.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 CONBRIZA
    D.2.1.1.2Name of the Marketing Authorisation holderWYETH EUROPE LTD.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameCONBRIZA
    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 INNBAZEDOXIFENE ACETATE
    D.3.9.1CAS number 198481-33-3
    D.3.9.2Current sponsor codeBAZEDOXIFENE ACETATE
    D.3.9.3Other descriptive nameBAZEDOXIFENE ACETATE
    D.3.9.4EV Substance CodeSUB16400MIG
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ambulatory postmenopausal women with low BMD in general good health
    Mujeres postmenopáusicas con baja densidad ósea y buen estado general
    E.1.1.1Medical condition in easily understood language
    Ambulatory postmenopausal women with low BMD in general good health
    Mujeres postmenopáusicas con baja densidad ósea y buen estado general
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10031289
    E.1.2Term Osteoporosis, unspecified
    E.1.2System Organ Class 100000004859
    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 change in Lumbar Spine Bone Mineral Density (BMD) at 12 months in postmenopausal women switching from daily, weekly or monthly bisphosphonates therapy at least for 3 years to Conbriza® 20mg oral(Bazedoxifene) once a day and calcium 500mg and 400IU vitamin D compared to that in subjects maintaining to only calcium 500mg and 400IU vitamin D daily
    El Objetivo primario del estudio consiste en evaluar el cambio en la densidad mineral ósea (DMO) de la columna lumbar a los 12 meses de tratamiento en mujeres posmenopáusicas que tras estar al menos 3 años con la terapia con bifosfonatos diarios, semanales o mensuales cambiaron a Conbriza® 20mg oral (Bazedoxifeno) una vez al día con calcio 500 mg y vitamina D 400 IU comparado con aquellos sujetos que mantuvieron sólo calcio 500 mg y vitamina D 400 IU (OSTINE )diariamente
    E.2.2Secondary objectives of the trial
    To evaluate the effects of switching to Conbriza® 20mg in comparison with switching to calcium 500mg and 400IU vitamin D daily on:

    - BTM`s CTX and P1NP at 12 months from baseline
    - BMD at the femoral neck at 6 and 12 months from baseline
    - BMD at total hip at 6 and 12 months from baseline
    - Safety changes in Mammography at 12 months from baseline
    Los objetivos secundarios son evaluar los efectos del cambio a Conbriza® 20mg en comparación con el cambio a Ca 500mg y vitamina D 400 IU (OSTINE) diarios en:
    - Marcadores de formación ósea: CTX (C-telepéptido del colágeno tipo 1 sérico) y P1NP (N-telepéptido del procolágeno del tipo 1) a los 12 meses desde la basal
    - DMO (Densidad Mineral Ósea) en cuello femoral a los 6 y 12 meses desde la basal
    - DMO (Densidad Mineral Ósea) de cadera total a los 6 y 12 meses desde la basal
    - Cambios de seguridad en Mamografía a los 12 meses desde la basal
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Provide signed informed consent before any study procedures are conducted
    Ambulatory postmenopausal women 55 years or older at screening
    Have received daily, weekly or monthly oral bisphosphonates at least for 3 years
    Subjects has stop bisphosphonates therapy at least one month before screening visit for subjects in daily or weekly bisphosphonates
    Subjects has stop bisphosphonates therapy at least two months before screening visit for subjects in monthly bisphosphonates
    Screening Tscore at the lumbar spine ? -2.0 to -4.0 by DXA scan
    At least 2 lumbar vertebrae must be evaluable by DXA
    Al least one hip must be evaluable by DXA (for secondary objectives)
    Que proporcionen el consentimiento informado antes del desarrollo del estudio
    - Han de ser mujeres de 55 años de edad o mayores - Que hayan recibido bifosfonatos diarios, semanales o mensuales durante al menos 3 años. Pacientes en los que esté indicado realizar el cambio de tratamiento, por no responder a los bifosfonatos, por problemas de tolerabilidad con la toma de bifosfonatos y por el posible riesgo a los efectos secundarios por ser un tratamiento largo, tal como ha indicado la FDA, EMA y AEMPS con las medidas a tomar en pacientes con un largo o prolongado tratamiento con bifosfonatos.
    - Que han finalizado la terapia con bifosfonatos al menos 2 meses antes de la visita de monitorización en sujetos con bifosfonatos mensuales
    - Con un T-score de ? -2,0 a -4,0 medido mediante escáner DXA.
    - Se han de evaluar por DXA al menos 2 vertebras lumbares
    - Se ha de evaluar por DXA al menos una cadera (para los objetivos secundarios)
    E.4Principal exclusion criteria
    Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
    Current use of medication prescribed for osteoporosis other than oral bisphosphonates
    Subjects who had received intravenous bisphosphonates or fluoride (except for dental treatment)
    Subjects who had received any Selective Estrogen Receptor Modulator (SERM), anabolic steroids, systemic hormone replacement, calcitonin or calcitriol within 3 months.
    Subjects who had received strontium ranelate, parathyroid hormone (PTH) or PTH derivates within 1 year.
    Hyper or hypothyroidism, current hyper or hypoparathyroidism
    History of VTE
    Significantly impaired renal function as determined by estimated Glomerular Filtration Rate less 35mL/min
    Hyper or hypocalcemia
    Vitamin D deficiency (serum 25 (OH) vit D level < 20 ng/mL (< 50nmol/L)
    Any condition that could result in impaired calcium metabolism or metabolic bone disease that could interfere with interpretation findings
    Any laboratory abnormality which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results
    Known intolerance to calcium supplements
    Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma cervical or breast ductal carcinoma in situ) within the last 5 years
    Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial
    Any physical or psychiatric disorder which, in the opinion of the investigator will prevent the subject from completing the study or interfere with the interpretation of the study results
    Evidence of alcohol or substance-abuse within the last 12 months which the investigator believes would interfere with understanding or completing the stud
    Cualquier desorden que comprometa la habilidad del sujeto para dar su consentimiento informado escrito y/o que comprometa la realización de los procedimientos del estudio
    - Que esté tomando otra medicación prescrita para la osteoporosis distinta a bifosfonatos.
    - Sujetos que hayan recibido bifosfonatos intravenosos o flúor (a excepción del tratamiento dental)
    - Sujetos que hayan recibido cualquier modulador selectivo de receptores estrogénicos (SERM), esteroides anabólicos, remplazo de hormona sistémica, calcitonina o calcitriol en 3 meses
    - Sujetos que han recibido ranelato de estroncio, hormona paratoidea (PTH) o derivados de PTH en un año.
    - Híper o hipotiroidismo, híper o hipoparatiroidismo actualmente.
    - Historia de TEV
    - Función renal disminuida determinada por una tasa de filtración glomerular estimada de menos de 35mL/min
    - Híper o hipocalcemia
    - Deficiencia de Vitamina D (serum 25 (OH) nivel de Vit D <20 ng/mL [<50nmol/L])
    - Cualquier condición que derive a un metabolismo del calcio deficiente o una enfermedad del metabolismo óseo que pueda interferir en la interpretación de los resultados
    - Cualquier anormalidad del laboratorio que, según la opinión del investigador, impida al sujeto completar el estudio o interfiera en la interpretación de los resultados.
    - Intolerancia conocida a los suplementos de calcio.
    - Malignidad (excepto carcinoma de células basales cutáneas completamente reseccionado o de células escamosas o carcinoma in situ cervical o de mama ductal) en los últimos 5 años
    - Que actualmente esté o no haya pasado el periodo de un mes desde que acabase otro ensayo con fármacos o dispositivo de investigación.
    - Cualquier desorden psiquiátrico o físico que, según la opinión del investigador, pueda impedir que el sujeto complete el estudio o interfiera en la interpretación de los resultados de éste.
    - Evidencia de abuso alcohólico en los últimos 12 meses que el investigador considere que pueda interferir en la interpretación de los resultados
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the change in Lumbar Spine Bone Mineral Density (BMD) at 12 months in postmenopausal women switching from daily, weekly or monthly bisphosphonates therapy to Conbriza® 20mg oral(Bazedoxifene) once a day and calcium 500mg and 400IU vitamin D compared to that in subjects switching to only calcium 500mg and 400IU vitamin D daily.
    To evaluate the effects of switching to Conbriza® 20mg in comparison with switching to calcium 500mg and 400IU vitamin D daily on BTM`s CTX and P1NP at 12 months from baseline
    To evaluate the effects of switching to Conbriza® 20mg in comparison with switching to calcium 500mg and 400IU vitamin D daily on Safety changes in Mammography at 12 months from baseline
    - To evaluate the effects of switching to Conbriza® 20mg in comparison with switching to calcium 500mg and 400IU vitamin D daily on BMD at the femoral neck at 6 and 12 months from baseline
    - To evaluate the effects of switching to Conbriza® 20mg in comparison with switching to calcium 500mg and 400IU vitamin D daily on BMD at total hip at 6 and 12 months from baseline
    - To evaluate the effects of switching to Conbriza® 20mg in comparison with switching to calcium 500mg and 400IU vitamin D daily on Subject reported treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM) and gastrointestinal symptoms using the Gastrointestinal Symptoms Rating Scale (GSRS) at baseline, months 6 and 12.
    Los objetivos exploratorios son evaluar los efectos del cambio a Conbriza® 20mg en comparación con el cambio a calcio 500 mg y vitamina D 400 IU diarios en:
    - La satisfacción del tratamiento notificada por el paciente a través del cuestinario de satisfacción del paciente al tratamiento con medicación ?Treatment Satisfaction Questionnaire for Medication? (TSQM)
    - Los síntomas gastrointestinales usando la escala de valoración de síntomas gastrointestinales ?Gastrointestinal Symptoms Rating Scale? (GSRS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 6 and 12 months.
    De 6 a 12 meses
    E.5.2Secondary end point(s)
    none
    ninguno
    E.5.2.1Timepoint(s) of evaluation of this end point
    none
    ninguno
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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 No
    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
    Due to this is a phase IV trial which is not going to determine any efficacy not safety for a new indication, trial will be finished when last visit from last patient will be done.
    Dado que se trata de un estudio clínico fase IV que no determina eficacia ni seguridad para registro de nueva indicación, el estudio finalizará una vez se complete la visita final del último paciente reclutado.
    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 months8
    E.8.9.1In the Member State concerned 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: 110
    F.1.3Elderly (>=65 years) No
    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 state110
    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)
    None
    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 Decision2013-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-13
    P. End of Trial
    P.End of Trial StatusCompleted
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