Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2005-005271-15
    Sponsor's Protocol Code Number:20050179
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-06-07
    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 ConcernedGermany - PEI
    A.2EudraCT number2005-005271-15
    A.3Full title of the trial
    A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate
    the Effect of Treatment with Denosumab (AMG 162) and Alendronate Sodium in
    Postmenopausal Women with Low Bone Mineral Density
    A.4.1Sponsor's protocol code number20050179
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 nameAbgenix l-6 CHO OPG Ligand mAb lgG2
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 nameFosamax
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 sodium
    D.3.9.3Other descriptive nameFosamax
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 placeboSolution 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 /osteopenia
    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
    The primary objective of the study is to estimate the effect of denosumab (AMG 162),
    compared to placebo on cortical thickness at the distal radius, as determined by in-vivo microCT (XtremeCT®) at 12 months.
    E.2.2Secondary objectives of the trial
    First four secondary objectives listed. Please see protocol (section 1.2) for remaining five secondary objectives.

    • Estimate the effect of denosumab, compared to placebo, on cortical thickness at the distal radius, as determined by XtremeCT® at 6 months
    • Estimate the effect of denosumab, compared to placebo, on cortical thickness at
    the distal tibia, as determined by in-vivo microCT (XtremeCT®) at 6 and 12 months
    • Estimate the effect of denosumab, compared to placebo, on cortical and trabecular volumetric bone density at the distal radius and the distal tibia, as determined by in-vivo XtremeCT® at 6 and 12 months
    • Estimate the effect of denosumab, compared to alendronate (ALN), on cortical and trabecular volumetric bone density and on cortical thickness at the distal radius and the distal tibia, as determined by XtremeCT® at 6 and 12 months
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Postmenopausal, ambulatory women between 50 and 70 years old.
    • Postmenopausal will be defined as no vaginal bleeding or spotting for at least 12
    months.
    • If the 12 months can not be confirmed (i.e.: hysterectomy), and if in the opinion of
    the investigator there is uncertainty regarding menopausal status, confirmation of
    serum FSH (≥ 50 mIU/mL) or serum estradiol (≤ 20 pg/mL) must be obtained.

    BMD values (g/cm2) at either the lumbar spine OR total hip as follows:
    • For lumbar spine, the BMD values (g/cm2) must be ≤ 0.940 (GE Lunar) or ≤ 0.827 (Hologic), OR
    • For total hip, the BMD values (g/cm2) must be ≤ 0.756 (GE Lunar) or ≤ 0.698
    (Hologic)
    BMD values (g/cm2) at both the lumbar spine and total hip as follows:
    • For lumbar spine, BMD values (g/cm2) ≥ 0.820 (GE Lunar) or ≥ 0.717 (Hologic),
    AND
    • For total hip, BMD values (g/cm2) ≥ 0.630 (GE Lunar) or ≥ 0.576 (Hologic)

    First and second lumbar vertebrae (L1 and L2) evaluable for DXA and QCT
    measurements
    Ethical - Before any study-specific procedure, the appropriate written informed
    consent must be obtained
    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.
    -History of a fragility fracture (a fracture resulting from no or minor trauma, i.e. a
    fall from standing height or less) of the wrist, humerus, hip or pelvis after age 50
    -Presence of moderate or severe vertebral deformity on VFA or lateral spine radiograph if VFA is not obtainable or evaluable.
    -Vitamin D deficiency [25(OH) vitamin D level < 12 ng/mL].
    -Evidence of any of the following per subject report, chart review or central
    laboratory result:
    a) Uncontrolled hyper- or hypothyroidism
    b) Current hyper- or hypoparathyroidism
    c) Elevated transaminases
    d) Impaired renal function as determined by serum creatinine ≥ 2.0 mg/dL
    e) Current hypo- or hypercalcemia determined by the central laboratory reference ranges for albumin adjusted serum calcium
    f) Active gastric or duodenal ulcer; history of significant gastrointestinal bleed
    requiring hospitalization or transfusion, or dyspepsia or gastroesophageal
    reflux disease that is uncontrolled by medication
    g) Rheumatoid arthritis, Paget’s disease, Cushing’s disease, hyperprolactinemia, or cirrhosis of the liver
    h) History of documented human immunodeficiency virus, hepatitis C virus, or
    hepatitis B
    i) Malignancy (except excised cutaneous basal cell, excised squamous cell
    carcinoma or excised cervical or breast ductal carcinoma in situ) within the
    last 5 years
    j) Any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta,
    which may interfere with the interpretation of study results
    k) Malabsorption syndrome or any gastrointestinal disorders associated with
    malabsorption
    -Received any solid organ or bone marrow transplant.
    -Contraindicated or poorly tolerant of ALN therapy.
    -Known sensitivity to mammalian cell derived drug products.
    -Known intolerance to elemental calcium supplements.
    -Any history of intravenous bisphosphonate, fluoride (except for dental treatment) or strontium ranelate use.
    -Oral bisphosphonate treatment.
    a) ≥ 3 months cumulatively, OR
    b) ≥ 1 month cumulatively in the past year, OR
    c) Any use during the 3-month period prior to randomization
    -Treatment with PTH or PTH derivatives within the last year
    -Administration of any of the following treatments within 3 months of randomization:
    a) Any SERM (e.g., raloxifene)
    b) Tibolone
    c) Anabolic steroids or testosterone
    d) Glucocorticosteroids (≥ 5 mg prednisone equivalent per day for more than 10
    days)
    e) Systemic (oral, transdermal, topical) hormone replacement therapy (local
    vaginal estrogen preparation will be allowed)
    f) Calcitonin
    g) Calcitriol or vitamin D derivatives
    h) Other bone active drugs including anti-convulsives (except benzodiazepines)
    and heparin
    i) Chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum,
    lithium, protease inhibitors, methotrexate, gonadotropin-releasing hormone
    agonists
    -Height, weight or girth which may preclude accurate DXA or QCT measurements.
    -Neither wrist evaluable by XtremeCT® (i.e., bilateral wrist replacement).
    -Neither hip evaluable by DXA and QCT (i.e., bilateral hip replacement or pins in
    both hips).
    -Presence of significant extremity tremor which, in the opinion of the investigator,
    would interfere with the XtremeCT® measurement.
    -Currently enrolled in or has not yet completed at least 1 month since ending
    other investigational device or drug trial(s), or subject is receiving other
    investigational agent(s).
    -Any laboratory abnormality or 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 study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is percent change in cortical thickness at the distal radius as determined by XtremeCT® from baseline to 12 months.
    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 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 Information not present in EudraCT
    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) Yes
    E.8.2.2Placebo Yes
    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.8.5The trial involves multiple Member States Yes
    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
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    Last subject last visit
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 100
    F.4.2.2In the whole clinical trial 240
    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 Decision2007-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    Protocol
    N.Date of Ethics Committee Opinion2006-10-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 03 14:08:25 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA