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    Summary
    EudraCT Number:2007-001041-17
    Sponsor's Protocol Code Number:20060289
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-08-16
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2007-001041-17
    A.3Full title of the trial
    An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety and Sustained Efficacy of Denosumab (AMG162) in the Treatment of Postmenopausal Osteoporosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Density
    A.4.1Sponsor's protocol code number20060289
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00523341
    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
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ Medical Info– Clinical trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O. Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post code(CH-)6300
    B.5.3.4CountrySwitzerland
    B.5.6E-mailMedinfoInternational@amgen.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 Prolia
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 AMG 162
    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.3.9.1CAS number 615258-40-7
    D.3.9.2Current sponsor codeAMG 162
    D.3.9.3Other descriptive nameImmunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
    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 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 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
    Treatment of postmenopausal osteoporosis
    E.1.1.1Medical condition in easily understood language
    Postmenopausal osteoporosis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    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
    To describe the safety and tolerability of up to 10 years or 7 years of denosumab administration as measured by adverse event monitoring, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab or placebo, respectively.

    E.2.2Secondary objectives of the trial
    To describe the
    -effect of denosumab administration on changes in lumbar spine, total hip and distal radius Bone Mineral Density (BMD) in subjects who previously received denosumab and in subjects who previously received placebo.
    -incidence of vertebral and non vertebral fractures following denosumab administration in subjects who previously received denosumab and in subjects who previously received placebo.
    -effect of denosumab administration on markers of bone turnover in subjects who previously received denosumab and in subjects who previously received placebo.
    -change in serum calcium values between the Baseline and Day 10 visit in subjects who previously received denosumab and in subjects who previously received placebo.
    -effect of up to 10 yrs denosumab administration on bone histology in subjects who previously received denosumab .
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Bone turnover markers sub-study (29 May 2007) – Serum for biochemical markers (Type 1 CTX, iPTH, RANKL, OPG, BALP, P1NP) will be collected in a subset of subjects who participated in the 20030216 bone marker substudy at Day 10, month 6, month 12 and month 24 visits to assess the effect of denosumab treatment on bone turnover and other bone parameters. At month 24, month 36, month 48, month 60, month 72 and month 84 serum for biochemical markers (CTX-1, P1NP) will be collected in subjects currently in the Bone Turnover Markers sub-study and in new subjects continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.

    DXA sub-study (29 May 2007) – Subjects who participated in the 20030216 DXA sub-study will be requested to undergo additional bone densitometry assessments of the distal radius at the month 12 and month 24 visits. At the month 24 visit new subjects and subjects currently in the DXA Radius sub-study will be requested to undergo additional bone densitometry assessments of the distal radius at the month 36, month 60 and month 84 visits.

    Transiliac bone biopsy sub-study (29 May 2007) - A target of approximately 50 subjects who received denosumab therapy for 5 and/or 10 years will be approached to undergo a transiliac bone biopsy to be obtained prior to or during the subject’s Month 24 and Month 84 visits. Additional blood samples will be collected at Month 84 to analyze bone turnover markers (CTX-1 and P1NP) in all the subjects participating in the bone biopsy substudy.

    Pharmacokinetics (PK) and Pharmacodynamics (PD) Sub-Study (25 October 2007) – Serum for denosumab levels (PK) and CTX-1 (PD) will be collected at Day 10, months 3, 4 and 6 in approximately 225 subjects who previously participated in the 20030216 PK sub-study.

    Quantitative computed tomography (QCT) substudy (15 July 2014)
    Approximately 30 subjects enrolled in the study and those who had participated in the QCT substudy in the preceding 20030216 trial will be requested to undergo QCT scans of the lumbar spine and proximal femur
    E.3Principal inclusion criteria
    Subjects must sign the informed consent before any study specific procedures are performed and agree to receive denosumab 60mg SC injection every 6 months.

    Subjects must not have discontinued investigational product during the 20030216 study and must have attended the 20030216 study month 36 visit.

    Subjects must be re-consented prior to (or at) the 24 month visit for participation beyond month 24.
    E.4Principal exclusion criteria
    - Permanently non-ambulatory subjects (use of an assistive device e.g. cane, walker etc is permitted)
    - Missed two or more investigational product doses during the 20030216 study
    - Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
    - Developed sensitivity to mammalian cell derived drug products during the 20030216 study
    - Unable to tolerate calcium supplementation during the last 6 months of participation in the 20030216 study (between the month 30 and month 36 20030216 study visits)
    - Currently receiving any investigational product other than denosumab or having received any investigational product during the 20030216 study
    - Current use of the following osteoporosis agents: bisphosphonates, calcitonin, fluoride, parathyroid hormone, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium or tibolone
    - For bone biopsy sub-study subjects only: known or suspected sensitivity or contraindication to tetracycline derivatives
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is safety monitoring, including adverse event incidence, serious adverse event incidence, changes in safety laboratory analytes (serum chemistry, hematology) and subject incidence of anti-denosumab antibody formation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 84 months
    E.5.2Secondary end point(s)
    • Actual values, changes and percent changes in BMD of the
    lumbar spine, total hip and distal radius from baseline
    • Actual values, changes and percent changes in BMD of the
    lumbar spine, total hip and distal radius from study 20030216
    baseline
    • Subject incidence of vertebral fractures
    • Subject incidence of non-vertebral fractures during the study
    markers from baseline
    • Actual values, changes and percent changes in bone turnover
    markers from study 20030216 baseline
    • Actual value, change and percent change from baseline in
    albumin-adjusted serum calcium
    • Serum denosumab concentrations
    • Actual values of bone biopsy measurements



    E.5.2.1Timepoint(s) of evaluation of this end point
    • Values and changes in BMD of the at all timepoints
    • Values and changes in BMD of the from study 20030216
    baseline at all timepoints
    • Subject incidence of vertebral fractures at months 24, 36, 60,
    and 84
    • Subject incidence of non-vertebral fractures during the study
    markers from baseline at all timepoints
    • Values and changes in bone turnover markers from study 20030216 baseline at all timepoints
    • Values and changes from baseline in albumin-adjusted serum calcium at Day 10
    • Serum denosumab concentrations at all timepoints
    • Values of bone biopsy measurements at months 24 and 84
    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 No
    E.8.1.1Randomised No
    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 No
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA148
    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
    Brazil
    Canada
    European Union
    Mexico
    Serbia
    Switzerland
    United States
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months10
    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: 107
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4443
    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 state187
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4395
    F.4.2.2In the whole clinical trial 5600
    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
    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 Decision2007-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-19
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