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    Summary
    EudraCT Number:2005-002984-10
    Sponsor's Protocol Code Number:SMC021A-2303
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-11-24
    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 ConcernedUK - MHRA
    A.2EudraCT number2005-002984-10
    A.3Full title of the trial
    A randomized, double-blind, multi-center, placebo-controlled study to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of osteoporosis in postmenopausal woman taking calcium and vitamin D
    A.4.1Sponsor's protocol code numberSMC021A-2303
    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 SponsorNordic Bioscience
    B.1.3.4CountryDenmark
    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 nameOral Calcitonin
    D.3.2Product code SMC021A
    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 INNcalcitonin
    D.3.9.3Other descriptive namesynthetic calcitonin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.8
    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.8 Information on Placebo
    D.8 Placebo: 1
    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
    The trial is Phase III.
    The population will be healthy post-menopausal women who are between 60 and 85 years of age
    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 safety objective is to characterize the safety and tolerability profile of SMC021 in this population based on the adverse event incidence and changes in laboratory profiles.
    Exploratory objectives include investigating new bone or cartilage markers that may become available.
    E.2.2Secondary objectives of the trial
    Additional objectives will be evaluated in sub studies:
    1. BMD sub study (equal number of study subjects from stratum A and B).

    Six hundred patients (300 on active treatment and 300 on placebo) will have their DXA BMD analyzed centrally:

    o The changes in BMD measured at the proximal femur (total hip, femoral neck) for all patients
    o The changes in BMD measured at the lumbar spine (L1 – L4) for all patients


    2. Pharmaco- dynamic sub-study (serum,CTX-I, osteocalcin, CTX-II and urine CTX I and II).

    One hundred patients (50 on active treatment and 50 on placebo) will have pharmaco-kinetic and -dynamic profiles at the beginning and the end of the study:

    o Serum calcitonin profile over 24 hours
    o Serum CTX-I and II, osteocalcin over 24 hours
    o Urine CTX-I and II over 24 hours
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    · Postmenopausal, ambulatory women, between 60 and 85 years old

    · Stratum A (50% of all enrolled subjects): BMD T-score £–2.5 at one or more of the following regions: the lumbar spine, femoral neck or total hip.

    OR

    · Stratum B (50% of all enrolled subjects): BMD T-score £ –1.5 at one or more of the following regions: the lumbar spine, femoral neck or total hip together with osteoporotic fracture(s) located at the spine according the definition of Genant et al (15).

    · Ethical - Before any study-specific procedure, the appropriate written informed consent must be obtained.
    E.4Principal exclusion criteria
    · In different regions of the world different values for the lowest level of BMD T-score and/or number and severity of prevalent vertebral fracture may apply. It will be up to the principal investigator to apply such limits that will satisfy the appropriate local ethical committees or health authorities.

    · For stratum A: more than 2 vertebral deformities (Genant et al, 15)

    · The presence of clinical vertebral fracture defined as a vertebral fracture associated with pain or functional disability.

    · BMD T-score > -1.5 in all of the following regions: Lumbar spine, femoral neck or total hip

    · Evidence of any of the following from medical history, laboratory results, DXA, or X-ray review:

    o History of renal stone
    o Current hyper- or hypothyroidism. Patients on stable thyroid treatment will be allowed
    o Current hyper- or hypoparathyroidism
    o Rheumatoid arthritis
    o Paget’s disease
    o Malignancy (except basal cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years
    o Any bone disease, e.g., osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings
    o Untreated or symptomatic malabsorption syndrome
    o Height, weight and girth which may preclude accurate DXA measurements
    o Advanced scoliosis or extensive lumbar fusion which would preclude vertebral fracture assessment
    o Less than 2 lumbar vertebrae (L1-L4) evaluable for DXA
    o Screening 25 (OH) vitamin D level less than 12 ng/mL. The patient may be treated with 50.000 IU oral 25 (OH) vitamin D per day for 2 weeks and serum vitamin D may then be retested. If the level is between 12 and 20 ng/mL, then the subject should be instructed to take at least 800 IU Vitamin D daily.
    o Serum levels of intact PTH above 65 pg/ml.
    o Current hypocalcaemia (albumin adjusted serum calcium below 2.13 mmol/L [8.5 mg/dL])


    · 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 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

    · 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)
    The primary efficacy endpoint to be assessed is the number of patients with new vertebral fracture.

    Safety endpoints include adverse events, changes in safety laboratory analyses (serum chemistry, hematology), and number of subjects with 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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months44
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months44
    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 Yes
    F.3.2Patients No
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2100
    F.4.2.2In the whole clinical trial 4500
    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 Decision2005-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-08-01
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