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    Summary
    EudraCT Number:2011-003142-41
    Sponsor's Protocol Code Number:20110142
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-05
    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 number2011-003142-41
    A.3Full title of the trial
    A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of AMG 785 in the Treatment of Postmenopausal Women With Osteoporosis
    studio multicentrico, internazionale, randomizzato, in doppio cieco controllato da alendronato per determinare l™efficacia e la sicurezza di AMG 785 nel trattamento di donne in post-menopausa affette da osteoporosi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Assess the Efficacy and Safety of AMG785 Treatment Compared to Alendronate in Postmenopausal Women with Osteoporosis
    Studio per valutare l'efficacia e sicurezza del trattamento con AMG 785 controllato da alendronato in donne in post menopausa con osteoporosi.
    A.4.1Sponsor's protocol code number20110142
    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 SponsorAMGEN INC.
    B.1.3.4CountryUnited States
    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 supportAmgen Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen Dompe' SpA
    B.5.2Functional name of contact pointDipartimento Regolatorio
    B.5.3 Address:
    B.5.3.1Street AddressVia E. Tazzoli, 6
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20154
    B.5.3.4CountryItaly
    B.5.4Telephone numberVia E. Tazzoli, 6 - Milano - 2
    B.5.5Fax number+390229005596
    B.5.6E-mailgbotta@amgendompe.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 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 nameNA
    D.3.2Product code AMG 785
    D.3.4Pharmaceutical form Solution for injection
    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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeAMG 785
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number210
    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 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 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 Yes
    D.3.11.13.1Other medicinal product typeanticorpo monoclonale
    D.IMP: 2
    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 Yes
    D.2.1.1.1Trade name FOSAMAX
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp and Dohme Corp.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 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 INNALENDRONATE MONOSODIQUE TRIHYDRATE
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB25824
    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 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 placeboSuspension for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Postmenopausal osteoporosis
    osteoporosi post menopausale
    E.1.1.1Medical condition in easily understood language
    Osteoporosis
    Osteoporosi
    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 PT
    E.1.2Classification code 10031285
    E.1.2Term Osteoporosis postmenopausal
    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
    For the overall study period (12-month double-blind alendronate [ALN]- controlled study period followed by the open-label ALN study period) • To assess the effect of AMG 785 treatment for 12 months followed by ALN treatment compared with ALN treatment alone on the subject incidence of clinical fracture (nonvertebral fracture and clinical vertebral fracture) in women with PMO • To assess the effect of AMG 785 treatment for 12 months followed by ALN treatment compared with ALN treatment alone on the subject incidence of new vertebral fracture in women with PMO
    Per tutto il periodo dello studio (12 mesi in doppio cieco controllato da alendronato [ALN] seguito da un
    periodo in aperto con ALN)
    • Valutare l’effetto del trattamento con AMG 785 per 12 mesi seguito dal trattamento con ALN
    rispetto al solo trattamento con ALN sull’incidenza nei soggetti di fratture cliniche (frattura non
    vertebrale e frattura vertebrale clinica) in donne affette da PMO
    • Valutare l’effetto del trattamento con AMG 785 per 12 mesi seguito dal trattamento con ALN
    rispetto al solo trattamento con ALN sull’incidenza nei soggetti di nuove fratture vertebrali in donne
    affette da PMO
    E.2.2Secondary objectives of the trial
    To assess the effect of AMG 785 treatment for 12 months followed by ALN treatment compared with ALN treatment alone on: • Subject incidence of fractures (all fractures [nonvertebral fractures and new vertebral fractures], new or worsening vertebral fracture, nonvertebral fracture, major nonvertebral fracture [pelvis, distal femur, proximal tibia, ribs, proximal humerus, forearm, and hip], hip fracture, and multiple new or worsening vertebral fracture) • Percent changes in Dual energy X-ray Absorptiometry (DXA) bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck To assess the effect of AMG 785 treatment for 12 months compared with ALN treatment on: • Subject incidence of fractures (clinical fracture [nonvertebral fracture and clinical vertebral fracture], new vertebral fracture, all fractures [nonvertebral fractures and new vertebral fractures])
    Per tutto il periodo dello studio (12 mesi in doppio cieco controllato da ALN seguito da un periodo in aperto con ALN) Valutare l’effetto del trattamento con AMG 785 per 12 mesi seguito dal trattamento con ALN rispetto al solo trattamento con ALN su: • Incidenza delle fratture nei soggetti (tutte le fratture [fratture non vertebrali e nuove fratture vertebrali], frattura vertebrale nuova o peggioramento di frattura pregressa, frattura non vertebrale, frattura non vertebrale grave [bacino, femore distale, tibia prossimale, costole, omero prossimale, avambraccio e anca], frattura dell’anca e fratture multiple vertebrale nuove o peggioramento di frattura vertebrale preesistente) • Variazioni percentuali della densità minerale ossea (BMD) della colonna lombare, dell’anca totale e del collo femorale mediante assorbimetria a raggi X a doppia energia (DXA)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    OTHER SUBSTUDIES:
    Italy won't take part to the substudy on biomarkers of bone turnover, imaging and pharmacokinetics

    ALTRI SOTTOSTUDI:
    Si precisa che l’Italia non parteciperà al sottostudio secondario, previsto dal protocollo, relativo a biomarcatori/marcatori del turnover osseo (BTM), imaging e farmacocinetica (PK).

    E.3Principal inclusion criteria
    4.1.1 Ambulatory postmenopausal women, age ≥ 60 to ≤ 90 years at randomization 4.1.2 BMD T-score ≤ -2.50 at the total hip or femoral neck and at least one moderate (SQ2) or severe (SQ3) vertebral fracture, as assessed by the central imaging vendor at the time of screening, based on DXA scans and lateral spine x-rays. 4.1.3 At least one hip is evaluable by DXA, as assessed by the principal investigator 4.1.4 Subject has provided informed consent
    4.1.1 Ambulatory postmenopausal women, age ≥ 60 to ≤ 90 years at randomization 4.1.2 BMD T-score ≤ -2.50 at the total hip or femoral neck and at least one moderate (SQ2) or severe (SQ3) vertebral fracture, as assessed by the central imaging vendor at the time of screening, based on DXA scans and lateral spine x-rays. 4.1.3 At least one hip is evaluable by DXA, as assessed by the principal investigator 4.1.4 Subject has provided informed consent
    E.4Principal exclusion criteria
    4.2.1 Strontium, fluoride (for osteoporosis), odanacatib (MK-0822): at any time 4.2.2 Intravenous (IV) bisphosphonates: dose received within 5 years prior to randomization 4.2.3 Oral bisphosphonates: • More than 3 years of cumulative use • Any dose received within 6 months prior to randomization More than 1 month of cumulative use between 6 and 12 months prior to randomization 4.2.4 Denosumab: dose received within 18 months prior to randomization 4.2.5 Teriparatide or any PTH analogs: dose received within 12 months prior to randomization 4.2.6 Systemic oral or transdermal estrogen, SERMs, or calcitonin: more than 1 month of cumulative use within 6 months prior to randomization 4.2.7 Androgen deprivation or hormonal ablation therapy: more than 1 month of cumulative use within 6 months prior to randomization 4.2.8 Tibolone or cinacalcet: dose received within 3 months prior to randomization 4.2.9 Systemic glucocorticosteroids: ≥ 5 mg prednisone equivalent per day for more than 10 days within 3 months prior to randomization 4.2.10 History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as Paget's disease, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome 4.2.11 History of solid organ or bone marrow transplants 4.2.12 Vitamin D insufficiency (defined as 25 (OH) vitamin D levels < 20 ng/mL as assessed by the central laboratory. Vitamin D repletion will be permitted and subjects may be rescreened once 4.2.13 Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range, as assessed by the central laboratory 4.2.14 Current, uncontrolled hyper- or hypothyroidism, defined as thyroidstimulating hormone outside of the normal range, per subject report or chart review 4.2.15 Current, uncontrolled hyper- or hypoparathyroidism, defined as PTH outside the normal range, per subject report or chart review 4.2.16 Possible diagnosis of multiple myeloma or related myeloproliferative disorder, as assessed by serum protein electrophoresis performed by the local laboratory 4.2.17 Exclusion criteria related to contraindications or possible signs of intolerance to ALN; contraindications and potential signs of intolerance for ALN therapy include: • Hypocalcemia (as defined in 4.2.13) • Abnormalities of the esophagus, which delay esophageal emptying such as stricture or achalasia • Inability to stand or sit upright for at least 30 minutes • Hypersensitivity to ALN or other constituents of ALN tablets • Increased risk of aspiration • Pregnancy and lactation • Other contraindications to ALN based on the country-specific product insert applicable to the specific study center • Significantly impaired renal function (as assessed by the central laboratory based on a derived creatinine clearance of < 35 mL/min using the Modification of Diet in Renal Disease. The estimated glomerular filtration rate is calculated as follows: estimated glomerular filtration rate (mL/min/1.73m2) = 175 x [Serum creatinine (mg/dL)]-1.154 x [Age]-0.203 x [0.742 if subject is female] x [1.210 if subject is black]. 4.2.18 General • Subject is currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s) • Subject has previously entered this study or has previously participated in a study with a sclerostin antibody product • Other investigational procedures are excluded • Malignancy except non-melanoma skin cancers, cervical or breast XML File Identifier: tGn+dfDjPJ4ntWh8RmhnMMjLt4E= Page 18/30 ductal carcinoma in situ within the last 5 years
    4.2.1 Strontium, fluoride (for osteoporosis), odanacatib (MK-0822): at any time 4.2.2 Intravenous (IV) bisphosphonates: dose received within 5 years prior to randomization 4.2.3 Oral bisphosphonates: • More than 3 years of cumulative use • Any dose received within 6 months prior to randomization More than 1 month of cumulative use between 6 and 12 months prior to randomization 4.2.4 Denosumab: dose received within 18 months prior to randomization 4.2.5 Teriparatide or any PTH analogs: dose received within 12 months prior to randomization 4.2.6 Systemic oral or transdermal estrogen, SERMs, or calcitonin: more than 1 month of cumulative use within 6 months prior to randomization 4.2.7 Androgen deprivation or hormonal ablation therapy: more than 1 month of cumulative use within 6 months prior to randomization 4.2.8 Tibolone or cinacalcet: dose received within 3 months prior to randomization 4.2.9 Systemic glucocorticosteroids: ≥ 5 mg prednisone equivalent per day for more than 10 days within 3 months prior to randomization 4.2.10 History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as Paget's disease, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome 4.2.11 History of solid organ or bone marrow transplants 4.2.12 Vitamin D insufficiency (defined as 25 (OH) vitamin D levels &lt; 20 ng/mL as assessed by the central laboratory. Vitamin D repletion will be permitted and subjects may be rescreened once 4.2.13 Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range, as assessed by the central laboratory 4.2.14 Current, uncontrolled hyper- or hypothyroidism, defined as thyroidstimulating hormone outside of the normal range, per subject report or chart review 4.2.15 Current, uncontrolled hyper- or hypoparathyroidism, defined as PTH outside the normal range, per subject report or chart review 4.2.16 Possible diagnosis of multiple myeloma or related myeloproliferative disorder, as assessed by serum protein electrophoresis performed by the local laboratory 4.2.17 Exclusion criteria related to contraindications or possible signs of intolerance to ALN; contraindications and potential signs of intolerance for ALN therapy include: • Hypocalcemia (as defined in 4.2.13) • Abnormalities of the esophagus, which delay esophageal emptying such as stricture or achalasia • Inability to stand or sit upright for at least 30 minutes • Hypersensitivity to ALN or other constituents of ALN tablets • Increased risk of aspiration • Pregnancy and lactation • Other contraindications to ALN based on the country-specific product insert applicable to the specific study center • Significantly impaired renal function (as assessed by the central laboratory based on a derived creatinine clearance of &lt; 35 mL/min using the Modification of Diet in Renal Disease. The estimated glomerular filtration rate is calculated as follows: estimated glomerular filtration rate (mL/min/1.73m2) = 175 x [Serum creatinine (mg/dL)]-1.154 x [Age]-0.203 x [0.742 if subject is female] x [1.210 if subject is black]. 4.2.18 General • Subject is currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s) • Subject has previously entered this study or has previously participated in a study with a sclerostin antibody product • Other investigational procedures are excluded • Malignancy except non-melanoma skin cancers, cervical or breast XML File Identifier: tGn+dfDjPJ4ntWh8RmhnMMjLt4E= Page 18/30 ductal carcinoma in situ within the last 5 years
    E.5 End points
    E.5.1Primary end point(s)
    During the overall study period (12-month double-blind ALN-controlled
    study period followed by the open label ALN study period)
    • Subject incidence of clinical fracture (nonvertebral fracture and clinical
    vertebral fracture) at primary analysis
    • Subject incidence of new vertebral fracture through Month 24
    Durante tutto il periodo dello studio (12 mesi in doppio cieco controllato da ALN seguito da un periodo in aperto con ALN) • Incidenza nei soggetti di fratture cliniche (frattura non vertebrale e frattura vertebrale clinica) all’analisi primaria • Incidenza nei soggetti di nuove fratture vertebrali fino al Mese 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    E.5.2Secondary end point(s)
    During the overall study period (12-month double-blind ALN-controlled study period followed by the open-label ALN study period) • Subject incidence of nonvertebral fracture at primary analysis • Subject incidence of all fractures (nonvertebral fracture and new vertebral fracture) at primary analysis • Subject incidence of new or worsening vertebral fracture through Month 24 • Subject incidence of major nonvertebral fracture (pelvis, distal femur, proximal tibia, ribs, proximal humerus, forearm, and hip) at primary analysis • Subject incidence of hip fracture at primary analysis • Subject incidence of multiple new or worsening vertebral fractures through Month 24 • Percent change from baseline in BMD at the lumbar spine, total hip, and femoral neck at Months 24 and 36 During the 12-month double-blind ALN-controlled study period • Subject incidence of clinical fracture (nonvertebral fracture and clinical vertebral fracture) through Month 12 • Subject incidence of new vertebral fracture through Month 12 • Subject incidence of all fractures (nonvertebral fracture and new vertebral fracture) through Month 12 • Percent change from baseline in BMD at the lumbar spine, total hip and femoral neck at Month 12
    Durante tutto il periodo dello studio (12 mesi in doppio cieco controllato da ALN seguito da un periodo in aperto con ALN) • Incidenza all’analisi primaria di fratture non vertebrali nei soggetti • Incidenza all’analisi primaria di tutte le fratture (frattura non vertebrale e nuova frattura vertebrale) nei soggetti • Incidenza nei soggetti di fratture vertebrali nuove o peggioramento di fratture vertebrali preesistenti fino al Mese 24 • Incidenza nei soggetti di fratture non vertebrali gravi (bacino, femore distale, tibia prossimale, costole, omero prossimale, avambraccio e anca) all’analisi primaria • Incidenza nei soggetti di fratture dell’anca all’analisi primaria • Incidenza nei soggetti di fratture vertebrali nuove o peggiorate multiple fino al Mese 24 • Variazioni percentuali dal baseline di BMD sulla spina lombare, l’anca totale e il collo femorale ai Mesi 24 e 36 Durante il periodo dello studio di 12 mesi in doppio cieco controllato da ALN • Incidenza nei soggetti di fratture cliniche (frattura non vertebrale e frattura vertebrale clinica) fino al Mese 12 • Incidenza nei soggetti di nuove fratture vertebrali fino al Mese 12 • Incidenza nei soggetti di tutte le fratture (frattura non vertebrale e nuova frattura vertebrale) fino al Mese 12 • Variazioni percentuali della BMD rispetto al basale nella colonna lombare, l’anca totale e il collo femorale al Mese 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 12 and 24
    mesi 12 e 24
    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) 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 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) Yes
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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
    Argentina
    Australia
    Brazil
    Canada
    Mexico
    New Zealand
    Peru
    South Africa
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    End of study (primary completion and end of trial) is defined as the
    time when clinical fracture events (nonvertebral fracture or clinical
    vertebral fracture) have been confirmed for at least 330 subjects but
    not before all subjects have had the opportunity to complete the Month
    24 visit.
    Fine di studio è definita come il
    momento in cui gli eventi clinici di frattura non vertebrale (o clinica
    fratture vertebrali) sono stati confermati in almeno 330 soggetti.
    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 months35
    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 months35
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3850
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2593
    F.4.2.2In the whole clinical trial 4000
    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)
    Normal treatment of the condition
    condizioni di trattamento normali
    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 Decision2012-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-06-29
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