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    Summary
    EudraCT Number:2009-010205-37
    Sponsor's Protocol Code Number:20080098
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-09-02
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2009-010205-37
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Compare the Efficacy and Safety of Denosumab versus Placebo in Males with Low Bone Mineral Density
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Compare the Efficacy and Safety of DenosumAb Versus Placebo in Males With Osteoporosis
    A.3.2Name or abbreviated title of the trial where available
    The ADAMO trial
    A.4.1Sponsor's protocol code number20080098
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00980174
    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 (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.3.8INN - Proposed INNDenosumab
    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
    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
    Male Osteoporosis
    E.1.1.1Medical condition in easily understood language
    Males With 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 14.0
    E.1.2Level PT
    E.1.2Classification code 10031282
    E.1.2Term Osteoporosis
    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
    The primary objective is to evaluate the effect of denosumab 60 mg Q6 months compared with placebo on lumbar spine BMD at 12 months in men with low BMD.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate the effects of denosumab in men with low BMD compared to placebo on
    • BMD at proximal femur (total hip, hip trochanter, femoral neck) and distal radius at 12 months
    • CTX at Day 15
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Transiliac Bone Biopsy Sub-study, 22 Jun 09
    A target of approximately 20 subjects enrolled at selected study sites will be requested to undergo a transiliac bone biopsy within 30 days prior to the month 12 visit in order to evaluate the effect of denosumab on bone histology and histomorphometry.
    E.3Principal inclusion criteria
    BMD values (g/cm2) assessed by the local site at either the lumbar spine OR femoral neck that occur within the following ranges, based on the particular scanner that is used:
    GE Lunar Hologic
    Lumbar spine 0.800 ≤ BMD ≤ 0.980 0.706 ≤ BMD ≤ 0.871

    Femoral neck 0.573 ≤ BMD ≤ 0.808 0.454 ≤ BMD ≤ 0.658
    OR
    For subjects with a history of a major osteoporotic fracture (clinical vertebral, hip, humerus and distal radius fractures) occurring more than 6 months prior to screening, BMD values (g/cm2) assessed by the local site, at either the lumbar spine OR femoral neck that occur within the following ranges, based on the particular scanner that is used:
    GE Lunar Hologic
    Lumbar spine 0.800 ≤ BMD ≤ 1.100 0.706 ≤ BMD ≤ 0.981

    Femoral neck 0.573 ≤ BMD ≤ 0.965 0.454 ≤ BMD ≤ 0.794

    At least 2 lumbar vertebrae, at least 1 hip and at least one forearm must be evaluable by DXA.
    Ambulatory males 30 to 85 years of age inclusive at the start of screening.
    Provide the appropriate written informed consent before any study-specific procedure.
    E.4Principal exclusion criteria
    BMD values (g/cm2) in subjects with or without a history of major osteoporotic fractures, based on the particular scanner that is used:
    GE Lunar Hologic
    Lumbar spine BMD < 0.800 BMD < 0.706

    Femoral neck BMD < 0.573 BMD < 0.454

    Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
    Any severe or more than 1 moderate vertebral fractures on screening spinal x-ray
    Any vertebral fracture diagnosed within the 6 months prior to screening
    Any clinical fracture within the last 6 months prior to screening
    For males with a partner of childbearing potential: Subject refuses to use 2 highly effective methods of contraception for the duration of the study and for 10 months after the last dose of study medication.
    For males with a partner who is pregnant: Subject refuses to use a condom for the duration of the study and for 10 months after the last dose of study medication.
    Previous participation in clinical trials with denosumab or administration of commercial denosumab.
    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).
    Vitamin D deficiency [25(OH) vitamin D level < 20 ng/mL (< 49.9 nmol/L)]. Vitamin D replenishment will be permitted and subjects may be re-screened; see Section 7.
    Hyper- or hypothyroidism; however, stable subjects, in the investigator’s opinion, on thyroid hormone replacement therapy are allowed.
    Hyper- or hypoparathyroidism. iPTH values outside of the reference range as determined by the central laboratory
    Elevated transaminases. Serum aspartate aminotransferase; serum glutamate-oxaloacetic transaminase > 2.5 x upper limit of normal. Serum alanine aminotransferase; serum glutamate-pyruvate transaminase > 2.5 x upper limit of normal (both as determined by the central laboratory).
    Significantly impaired renal function as determined by a derived glomerular filtration rate (using the Modification of Diet in Renal Disease formula) of ≤ 30 mL/min/1.73 m2 calculated by the central laboratory.
    Hypo- or hypercalcemia based on the central laboratory reference ranges for albumin-adjusted serum calcium.
    Known to have tested positive for human immunodeficiency virus, hepatitis C virus, hepatitis B surface antigen or cirrhosis of the liver.
    Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma) within the last 5 years.
    Any metabolic bone disease, eg osteomalacia, osteogenesis imperfecta, rheumatoid arthritis, Paget’s disease, Cushing’s disease or, hyperprolactinemia which may interfere with the interpretation of the findings OR evidence of malabsorption syndromes which might interfere with absorption of vitamin D.
    Received any solid organ or bone marrow transplant or is on chronic immunosuppression for any reason.
    Any laboratory abnormality, which in the opinion of the investigator or Amgen, will prevent the subject from completing the study or interfere with the interpretation of the study results.
    Administration of intravenous bisphosphonate, or fluoride (except for dental treatment) or strontium ranelate.
    Oral bisphosphonate treatment:
    • ≥ 3 months cumulatively in the past 2 years, OR
    • ≥ 1 month in the past year, OR
    • Any use during the 3-month period prior to randomization
    Administration of any of the following treatments 3 months prior to screening:
    • Anabolic steroids or testosterone
    • Glucocorticosteroids (≥ 5 mg prednisone equivalent per day for more than 10 days or a total cumulative dose of ≥ 50 mg)
    • Calcitonin
    • Calcitriol or vitamin D derivatives [vitamin D contained in supplements or multivitamins is allowed]
    • Other bone active drugs including anti-convulsives (except benzodiazepines) and heparin
    • Chronic systemic ketoconazole, ACTH (adrenocorticotrophic hormone), cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, gonadotropin-releasing hormone agonists.
    • Androgen deprivation therapy
    Known sensitivity to mammalian cell derived drug products.
    Known intolerance to calcium or vitamin D supplements.
    Height, weight or girth which may preclude accurate DXA measurements.
    Bilateral hip replacements
    Any physical or psychiatric disorder which, in the opinion of the investigator or Amgen, 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 of or completion of the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the percent change from baseline in the lumbar spine BMD
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 12 months
    E.5.2Secondary end point(s)
    - Percent change from baseline in BMD of the total hip, femoral neck, hip trocanter and distal radius - Percent change from baseline in CTX
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Percent change from baseline in BMD of the total hip, femoral neck, hip trocanter and distal radius at Month 12
    - Percent change from baseline in CTX at Day 15
    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) No
    E.8.2.2Placebo Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    European Union
    Canada
    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
    End of study is defined as the date the last on study subject completes the final study visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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 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.1.2.1Number of subjects for this age range: 102
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 138
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 166
    F.4.2.2In the whole clinical trial 232
    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 Decision2009-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-05-15
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    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
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