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    Summary
    EudraCT Number:2004-000138-35
    Sponsor's Protocol Code Number:20030216
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-06-16
    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 ConcernedSweden - MPA
    A.2EudraCT number2004-000138-35
    A.3Full title of the trial
    A Study to Evaluate AMG 162 in the Treatment of Postmenopausal Osteoporosis
    FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis every & Months)
    A.4.1Sponsor's protocol code number20030216
    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 nameAMG 162 solution for injection
    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 nameAbx 1-6 CHO OPG Ligand mAb IgG2; Human Monoclonal Antibody to RANKL
    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 Information not present in EudraCT
    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
    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
    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 is to determine whether denosumab (formerly known as AMG 162 treatment can reduce the number of postmenopausal osteoporotic women (BMD T-score below -2.5) with inew vertebral fractures as compared with control (placebo plus vitamin D and calcium).

    The primary safety objective is to characterize the safety and tolerability profile of denosumab in this population based on the adverse event incidence, changes in laboratory profiles, and immunogenicity to denosumab.
    E.2.2Secondary objectives of the trial
    Secondary objectives will be to assess the effect of denosumab on time to first non-vertebral fracture and time to first hip fracture.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Postmenopausal women, between 60 and 90 years old
    - BMD T-score < –2.5 at one or more of the following regions: the lumbar spine, total hip, or femoral neck
    - Ethical - Before any study-specific procedure, the appropriate written informed consent must be obtained
    E.4Principal exclusion criteria
    - BMD T-score < -4.0 at one or more of the following regions: Lumbar spine, total hip, or femoral neck
    - Oral bisphosphonate treatment for osteoporosis:
    Ineligible if used for 3 or more years cumulatively;
    If used for >3 months, but ≤ 3 years, at least a one year period since last dose is necessary for eligibility;
    If used ≤ 3 months at any time in the past, subject is eligible.
    - Administration of intravenous bisphosphonate, fluoride or strontium for osteoporosis within the last 5 years
    - Administration of any of the following treatments within the last 6 weeks:
    a) PTH or PTH derivatives, eg, teriparatide
    b) Anabolic steroids or testosterone
    c) Glucocorticosteroids (> 5 mg prednisone equivalent per day for more than 10 days)
    d) Systemic hormone replacement therapy
    e) Selective estrogen receptor modulators (SERMs), eg, raloxifene
    f) Tibolone
    g) Calcitonin
    h) Calcitriol
    - Evidence of any of the following per patient report, chart review, DXA, or X-ray review:
    a) Hyper or hypothyroidism; patients on stable thyroid treatment with a normal TSH will be allowed
    b) Current hyper- or hypoparathyroidism
    c) Current hypocalcemia (albumin adjusted serum calcium below 2.13 mmol/L [8.5 mg/dL])
    d) Vitamin D deficiency [(25) hydroxy Vitamin D level < 12 ng/mL)
    e) Rheumatoid arthritis
    f) Paget’s disease
    g) Malignancy (except basal cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years
    h) Any bone disease, eg, osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings
    i) Malabsorption syndrome
    j) Height, weight and girth which may preclude accurate DXA measurements
    k) Advanced scoliosis or extensive lumbar fusion which would preclude vertebral fracture assessment
    l) Any severe or more than 2 moderate vertebral fractures on spinal X-rays (see section 7.9)
    m) Less than 2 lumbar vertebrae (L1-L4) evaluable for DXA
    - Known sensitivity to mammalian cell derived drug products
    - Any organic or psychiatric disorder, or 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
    - Evidence of alcohol or substance-abuse within the last 12 months that the investigator believes would interfere with understanding or completing the study
    - Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
    - For biopsy sub study subjects only: known or suspected sensitivity or contraindication to tetracycline derivatives
    - Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy
    - Subject incidences of new vertebral fractures (Yes/No) during the entire 36 month treatment period.

    Safety
    - Adverse event incidence by system organ class and preferred term
    - Changes in safety laboratory analytes (serum chemistry, hematology) at each visit
    - Numebr of subjects with anti-AMG 162 antibodies (Yes/No)
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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.8.3 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 visit of the last subject undergoing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state135
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6264
    F.4.2.2In the whole clinical trial 7869
    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)
    Expected normal treatment
    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 Decision2004-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-07-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-10-14
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