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    The EU Clinical Trials Register currently displays   44048   clinical trials with a EudraCT protocol, of which   7319   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).

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    Summary
    EudraCT Number:2008-005991-28
    Sponsor's Protocol Code Number:20060326
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-05-25
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2008-005991-28
    A.3Full title of the trial
    A Randomized, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 785 in the Treatment of Postmenopausal Women with Low Bone Mineral Density / Estudio de fase 2 aleatorizado, controlado con placebo, de dosis múltiple para determinar la eficacia, la seguridad y la tolerabilidad de AMG 785 en el tratamiento de mujeres posmenopáusicas con baja densidad mineral ósea
    A.4.1Sponsor's protocol code number20060326
    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 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 nameAMG 785
    D.3.2Product code AMG 785
    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.3.8INN - Proposed INNAMG 785
    D.3.9.2Current sponsor codeAMG 785
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 No
    D.3.11.8Extractive medicinal product No
    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 Yes
    D.2.1.1.1Trade name Fosamax Semanal 70 mg comprimidos
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP AND DOHME DE ESPAÑA, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 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 INNALENDRONATO SODIO
    D.3.9.3Other descriptive nameALENDRONATO SODIO
    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 No
    D.3.11.8Extractive medicinal product No
    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: 3
    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 FORSTEO 20 microgramos/80 microlitros, solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY NETHERLAND BV
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 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.3.8INN - Proposed INNTERIPARATIDA
    D.3.9.1CAS number 52232-67-4
    D.3.9.3Other descriptive nameTERIPARATIDE
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 No
    D.3.11.8Extractive medicinal product No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postmenopausal osteoporosis / Osteoporosis postmenopáusica
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10031285
    E.1.2Term Osteoporosis postmenopausal
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect of treatment with AMG 785 versus placebo at month 12 on the percent change from baseline in bone mineral density (BMD) at the lumbar spine in postmenopausal women with low bone density.
    E.2.2Secondary objectives of the trial
    To study the effects of up to 12 months of treatment with AMG 785 versus placebo on the percent change from baseline:
    - in BMD at lumbar spine (at month 6), total hip and femoral neck (at months 6 and 12), and distal radius (at month 12), and
    - in bone turnover markers (BTMs).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    -Quantitative Computed Tomography. Date,Ver.: 20 Mar 09, Amend.4.Object.: To investigate the effect of AMG785 on trabecular and cortical bone as assessed by QCT of the spine and/or proximal femur. -Iliac Crest Bone Biopsy. Date,Ver.: 20 Mar 09, Amend. 4. Object.: To investigate the effect of AMG 785 on bone histology and histomorphometry based on transiliac bone biopsies. -24-Hour Urine Collection. Date, Ver.: March 09, Amend. 4.Object.: To determine 24h calcium levels.
    E.3Principal inclusion criteria
    To be eligible for enrollment subjects must meet the following criteria:

    - Ambulatory, postmenopausal women (based on medical history) aged > or = 55 to < or = 85. Postmenopausal will be defined as no vaginal bleeding or spotting for at least one year. If there is uncertainty regarding menopausal status:

    - Women 60 years of age and older will be considered postmenopausal

    - Women 55-59 must have confirmation of serum FSH > or = 50 mIU/ml and serum estradiol < or = 20 pg/mL at screening

    - Low BMD measured by Dual energy X-ray Absorptiometry (DXA) and assessed by the central imaging vendor (refer to table below for eligible BMD values).

    - Subjects must have at least two evaluable vertebrae in the L1-L4 region, and at least one evaluable hip.

    - Subjects must not have a BMD value at any anatomical site (lumbar spine, total hip and femoral neck) that is below the lower limit specified for that site.

    - Scans will be done in duplicate and the mean of the scans from at least one anatomical site (lumbar spine, total hip or femoral neck) must meet the BMD values defined in table below.

    Eligible BMD values; Lunar (g/cm2); Hologic (g/cm2)

    Lumbar Spine (a); < or =0.940 and > or = 0.760; < or= 0.827and > or = 0.662
    Total Hip (b); < or= 0.756 and > or =0.567; < or= 0.698 and > or = 0.515
    Femoral Neck (b); < or= 0.760 and > or = 0.551; < or= 0.618 and > or =0.438

    (a) Values correspond to T-scores between -2.0 and -3.5 as determined by the manufacturer
    (b) Values correspond to T-scores between -2.0 and -3.5 Based on data for Caucasian women from the National Health and Nutritional Examination Survey (NHANES) 1998
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria are not eligible for participation in the study:

    - History of vertebral fracture or fragility fracture (a fracture resulting from no or minor trauma, ie fall from standing height or less) of the wrist, humerus, hip or pelvis after age 50.

    - History of metabolic or bone disease that may interfere with the interpretation of the results, such as Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome.

    - Vitamin D deficiency (defined as 25 (OH) vitamin D levels < 20 ng/mL as determined by the central laboratory. Vitamin D repletion will be permitted and subjects may be re-screened once.

    - Evidence of any of the following:

    - Untreated hyper- or hypothyroidism (TSH out of normal range as determined by the central laboratory).
    - Current hyper- or hypoparathyroidism (PTH outside the normal range as determined by the central lab).
    - Elevated transaminases as determined by the central laboratory.

    a) Serum aspartate aminotransferase (AST; serum glutamate-oxaloacetic transaminase [SGOT]) > or = 2.0 x upper limits of normal.

    b) Serum alanine aminotransferase (ALT; serum glutamate-pyruvate transaminase [SGPT]) > or = 2.0 x upper limits of normal.

    - Significantly impaired renal function as determined by a derived creatinine clearance of less than or equal 30 mL/min using the Modification of Diet in Renal Disease equation, calculated by the central laboratory.

    - Current hyper- or hypocalcemia as determined by the central laboratory analysis of albumin adjusted serum calcium.

    - History of spinal stenosis.

    - History of facial nerve paralysis.

    - Known to have tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen.

    - Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years.

    - History of solid organ or bone marrow transplants.

    - Use of the following agents affecting bone metabolism:

    - Intravenous bisphosphonates at any time in the past.
    - Fluoride (for osteoporosis) within the past 24 months.
    - Denosumab at any time in the past.
    - Bisphosphonates, parathyroid hormone or strontium within the past 12 months.
    - Calcitonin, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable) or tibolone within the past 3 months.
    - Systemic glucocorticosteroids (> or = 5 mg prednisone equivalent per day for more than 10 days) within the past 3 months.

    - Contraindicated or intolerant of ALN therapy; contraindications and potential signs of intolerance for ALN therapy include:

    - Abnormalities of the esophagus and other factors which delay esophageal emptying such as stricture or achalasia.
    - Inability to stand or sit upright for at least 30 minutes.
    - Hypersensitivity to ALN or any component of the ALN product.
    - 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.

    - Contraindicated or intolerant of TPTD therapy; contraindications for TPTD therapy include:
    - Hypersensitivity to teriparatide or to any of its excipients.
    - Unexplained elevations of alkaline phosphatase.
    - Prior external beam or implant radiation therapy involving the skeleton.
    - Bone metastases or a history of skeletal malignancies.

    - Known sensitivity to mammalian cell derived drug products.

    - Known intolerance to calcium supplements.

    - Previous enrollment in an AMG 785 clinical study.

    - Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s).

    - Any condition which in the opinion of the investigator.

    - Compromises the ability of the subject to give written informed consent.
    - Prevents the subject from complying with study procedures.
    - Prevents the subject from completing the study.
    - Interferes with the interpretation of study results.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the percent change from baseline at month 12 in BMD at the lumbar spine for the individual AMG 785 groups and pooled placebo arms.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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) 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 Yes
    E.8.2.3.1Comparator description
    The study is placebo-controlled with open label active comparators
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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 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
    The end of study (EOS) will be the date on which the final subject completes the final
    study procedure. However, subjects with neutralizing antibodies present at EOS will
    return to the clinic approximately every 12 weeks for blood sampling to test for presence of neutralizing antibodies. Subjects will be followed for a period of one year or until the neutralizing antibodies are no longer detectable, whichever comes first.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=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 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 187
    F.4.2.2In the whole clinical trial 400
    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 Decision2009-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-03
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