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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7272   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:2011-006152-36
    Sponsor's Protocol Code Number:1774
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-05-10
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2011-006152-36
    A.3Full title of the trial
    Postoperative treatment with parathyroidea hormone Forteo® in
    patients undergoing posterolateral spinal fusion surgery. A prospektive
    and a randomized double-blinded, placebo-controlled study
    Parathyroidea hormon behandling ved non-instrumenteret posterolateral
    spondylodese.
    - Prospektivt, dobbeltblindet, randomiseret placebo kontrolleret studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Does postoperative treatment with parathyroidea hormone Forteo®
    improve the disability in
    elderly patients undergoing spinal stabilization fusion surgery compared
    with patients treated with placebo. If that is the case, is there a correlation
    between improvement of disability and solid osseous healing?
    Kan parathyroidea hormon (PTH) i form af lægemidlet Forsteo forbedre
    funktionsniveauet ved uinstrumenteret stivgørende operation i
    lænderyggen på ældre patienter, i forhold til placebobehandling. I så fald
    kan denne forbedring, forklares ved at patienterne opnår en forbedret
    knogleheling?
    A.3.2Name or abbreviated title of the trial where available
    PTH-U-DESE-STUDY
    PTH-U-DESE-STUDIET
    A.4.1Sponsor's protocol code number1774
    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 SponsorMiddelfart Rygsektor
    B.1.3.4Country
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEli Lilly
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRygkirurgisk forskningsenhed, SLB
    B.5.2Functional name of contact pointKaren Højmark
    B.5.3 Address:
    B.5.3.1Street AddressØstre Hougvej 55
    B.5.3.2Town/ cityMiddelfart
    B.5.3.3Post code5500
    B.5.4Telephone number004563484198
    B.5.5Fax number004563484281
    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 Forteo
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameForsteo
    D.3.2Product code 0002-8971
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    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 INNteriparatide [rDNA origin] contains recombinant human parathyroid hormone (1-34)
    D.3.9.1CAS number 52232-67-4
    D.3.9.3Other descriptive namerhPTH (1-34)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 No
    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 placeboInjection
    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
    Spinal stenosis
    Spinal stenose
    E.1.1.1Medical condition in easily understood language
    Spinal stenosis, a painful condition which often results in reduced
    walking distance. It is caused by compression of neural structures in the
    spinal canal
    Operationskrævende forsnævret rygmarvskanal(spinalstenose) betinget
    af en fremadglidning af en lænderyghvirvel (spondylolisthesis).Det er en smertefuld lidelse og kan reducere patientens gangdistance.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10041597
    E.1.2Term Spinal stenosis of lumbar region
    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 aim of this study is to examine the effect on
    clinical outcome of postoperative treatment with Forteo® by evaluating self reported disability,(ADL functions-data) in elderly patients undergoing spinal stabilization surgery compared with
    placebotreatment.
    Det primære formål med projektet er, at belyse, hvorledes behandling med parathyroidea
    Hormon (PTH) i form af lægemidlet Forsteo, påvirker det kliniske operationsresultatet. Vi evaluerer selvreporteret funktionsniveau, ADL funktions data præ og postoperativt efter uinstrumenteret stivgørende operation i lænderyggen på ældre patienter i forhold til
    Placebobehandling.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to define
    -if the patients walking
    distance is improved
    - if the level of pain is reduced.
    And if a better fusionrate on CT and DEXA -scan
    correlate with the functional outcome of treatment with Forteo®, i.e. if
    the walking
    distance is improved or the level of pain is reduced.
    Det sekundære formål er, at se om patienter behandlet med Forsteo som tillægsbehandling opnår hurtigere fremskridt i forhold til placebobehandling mht. følgende
    nedenstående endpoints.
    • en forøgelse af gangdistance ud fra forskellen af gangdistancen præ
    og postoperativt, som måles på et løbebånd i et træningsrum beliggende
    ved siden af rygkirurgisk sengeafsnit, afd. R, Middelfart Sygehus.
    • en forbedring af deres bensmerter vurderet ud fra en VAS-score
    Samt at belyse om der er en sammenhæng imellem en evt. forbedring og visualiseret heling set på
    røntgen, "thin slice CT" (CT-scanning og DEXA –
    skanninger) med det kliniske operationsresultat, som f.eks. forbedring i gangdistancen eller ved reduktion af smerte.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Spinal stenosis verified by MRI
    Age 60 or above
    No diagnosed dementia
    (MMSE 24 of 30 correct answers)
    Considerable reduction in walking distance which
    has not improved during conservative treatment
    Spinal stenose verificeret ved MR-scanning
    Alder over 60 år
    Ingen demens (MMSE 24 ud af 30)
    Reduceret gangdistance med kraftige bensmerter, som ikke har oplevet effekt af konservativ behandling.
    E.4Principal exclusion criteria
    Contraindication for PTH treatment
    Major deformity
    Mental illness
    Spinal cord compression due to infection or
    malignant disease
    Resent spinal fracture
    hypercalcemia
    Reduced kidney function
    Metabolic bone disease, including
    hypophosphatemia
    Untreated anti coagulant treatment
    Previous radiation therapy
    Haematological disorders
    Previously fusion spinal surgery
    Age under 60

    Kontraindikationer for PTH-behandling vurderet udfra referenceværdier
    på blodprøvesvar samt anamnese. (Ophobning af calcium i blodet, stærk
    nedsat nyrefunktion, knogle forstyrrende sygdomme, inkl.
    hyperparathyrodisme og Mb. Paget, Ondartet lidelse.
    Infection
    Svær sindslidelse
    Tidligere strålet behandlet
    Blodsygdom (hæmatologisk sygdom)
    Brud af rygsøjlen inden for det sidste år
    Tidligere stivgørende rygoperation (spondylodeseoperation)
    Alder under 60 år
    Patienter, som har behov for tablet behandling med prednisolon.
    Kontinuerlig medicinsk behandling med vitamin K antagonist
    (f.eks.Warfarin)
    Behersker ikke det danske sprog (læse og tale)
    Alkoholisme eller stofmisbrug.
    Demens vurderet ved en test (MMSE-test) (mindst 24 af 30 rigtige svar)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is to examine the effect and
    clinical outcome of postoperative treatment with Forteo in elderly patients undergoing spinal stabilization surgery compared with placebotreatment using selfreported questionnaires evaluating disability (DPQ, SF36, ODI, and EQ-5D) præ and postoperative.
    Det primære formål er, at belyse, hvorledes behandling med parathyroidea
    Hormon (PTH) i form af lægemidlet Forsteo påvirker det kliniske operationsresultatet efter uinstrumenteret stivgørende operation, ved at evaluere patientens daglige selvreporteret funktionsniveau vurderet, ved at
    sammenligne scoren af DPQ, SF36, ODI og EQ-5D i spørgeskemaerne præ og postoperativt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    By measuring the patients' state of health and disability ADL functions-data (DPQ) before at inclusion (baseline) and after
    3,6,12 and 24 months.
    Patienterne ses til en klinisk kontrol, hvor ADL funktions-data (DPQ) vha. spørgeskemaer opsamles og evalueres ved baseline og ved postoperative kontroller efter 3, 6, 12 og 24 måneder.
    E.5.2Secondary end point(s)
    Secondary endpoints are testing the patients walking distance, level of pain (especially legpain) and use of analgesics præ and postoperative at (baseline) and after
    3,6,12 and 24 months after.

    Also DEXA- scans (and blood samples control for monitoring the patients calcium level) controls at OUH, Odense, where the patients' fusionrate and fusion mass are evaluated at (baseline) and after
    10 days,1,3,6,12 month.
    Futher “Thin slice CT” controls are evaluated postoperative at 6 and 12 months to evaluate the fusionrate.
    Endvidere ønskes følgende
    nedenstående kliniske sekundære endpoints belyst.
    • gangdistance ud fra forskellen af gangdistancen præ
    og postoperativt, som måles på et løbebånd i et træningsrum beliggende
    ved siden af rygkirurgisk sengeafsnit, afd. R, Middelfart Sygehus.
    • Patientens bensmerter vurderet ud fra en VAS-score.
    • medicinforbrug ved at sammenligne forbruget, som oplyses i
    anamnesen og i spørgeskemaerne præ og postoperativt

    Endvidere bliver patientens blodprøver(calcium niveauet) kontrolleret af medicinsk rådgivende læge
    på endokrinologisk, afd. M på OUH med blodprøver og DEXA
    skanning, præoperativt og 10 dage, 1, 3, 6 mdr. og 12 mdr. efter
    operationen. Ved samtlige postoperative kontroller i Middelfart
    indsamles ADL funktions-data vha. spørgeskemaer.
    6 og 12 mdr. efter operationen vil der ligeledes blive fortaget en "Thin
    slice CT"-skanning af operationsområdet for at vurdere graden af
    helingen.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline (10 days and 1 month), 3,6,12 and 24 months.
    Baseline (10 dage og 1 mdr), 3,6,12 and 24 mdr.
    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 No
    E.6.5Efficacy No
    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.6.13.1Other scope of the trial description
    To examine whether there is a positive effect of injecting Forteo during the first postoperative period after fusion
    surgery.
    At evaluere om patienter behandlet med Forsteo som tillægsbehandling oplever hurtigere fremskridt i forhold til placebobehandling mht. følgende ovenstående endpoints.
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 trial ends when 2 x 50 patients are treated and followed in the
    randomized study. Hopefully May 2015.
    Projektet afsluttes når 2X 50 patienter har været set til den sidste kliniske postoperative kontrol efter 24 måneder på Middelfart sygehus. Projektet
    forventes afsluttet 1. maj 2015.
    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 months6
    E.8.9.1In the Member State concerned days0
    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.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 85
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state100
    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)
    There is no treatment or care after the patients have ended the participation in the trial
    Der gives ikke nogen form for efter behandling, idet PTH ikke er selve behandlingen men et lægemiddel, som skal understøtte den oprindelige rygkirurgiske behandling.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-13
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