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    Summary
    EudraCT Number:2011-000628-14
    Sponsor's Protocol Code Number:ISS20109714
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-08-22
    Trial 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 ConcernedFinland - Fimea
    A.2EudraCT number2011-000628-14
    A.3Full title of the trial
    Denosumab in enhancement of bone bonding of hip prosthesis in postmenopausal women: a randomized, double-blind, placebo-controlled study
    Satunnaistettu, kaksoissokkoutettu, lumekontrolloitu kliininen tutkimus denosumabin tehokkuudesta lonkan tekonivelen kiinnittymisen edistäjänä
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prolia medication in enhancement of implant healing in female patients after hip replacement
    Prolia lääkitys lonkan tekonivelen paranemisen edistäjänä naispotilailla
    A.3.2Name or abbreviated title of the trial where available
    Hip-Prolia
    Hip-Prolia
    A.4.1Sponsor's protocol code numberISS20109714
    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 SponsorTurku University Hospital
    B.1.3.4CountryFinland
    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 supportAmgen AB
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen AB
    B.5.2Functional name of contact pointSivuliike Suomessa
    B.5.3 Address:
    B.5.3.1Street AddressKeilaranta 16
    B.5.3.2Town/ cityEspoo
    B.5.3.3Post code02101
    B.5.3.4CountryFinland
    B.5.4Telephone number3580954900500
    B.5.5Fax number3580954900511
    B.5.6E-mailpaivi.lakkakorpi@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 BV
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 nameProlia
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 placeboSuspension for injection in pre-filled syringe
    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
    Hip osteoarthritis
    Lonkan nivelrikko
    E.1.1.1Medical condition in easily understood language
    Hip arthritis
    Lonkan kuluma
    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 10020104
    E.1.2Term Hip total replacement
    E.1.2System Organ Class 100000004865
    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 hypothesis for this trial is that denosumab compared with placebo is effective in preventing periprosthetic bone loss in the proximal femur of female patients after total hip replacement
    Tutkimuksen hypoteesina on, että denosumabi voi estää paikallista luukatoa proteesin varren ympärillä naispotilailla lonkan tekonivelleikkauksen jälkeen
    E.2.2Secondary objectives of the trial
    The secondary hypothesis is that denosumab is effective in enhancement of bone bonding (osseointegration) of cementless hip prosthesis and prevents delayed bonding in osteoporotic postmenopausal women
    Toisena hypoteesina on, että denosumabi voi edistää proteesin kiinnittymistä ja estää proteesin hidastuneen kiinnittymisen osteoporoosia sairastavilla postmenopausaalisilla potilailla.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Postmenopausal women, age: ≥ 60 years to ≤ 85 years at randomization
    • Degenerative primary hip OA as the indication of hip replacement
    • Signed informed consent
    • Postmenopausaaliset naiset (ikä 60-85 vuotta)
    • Lonkan degeneratiivinen nivelrikko
    • Allekirjoitettu suostumuskaavake
    E.4Principal exclusion criteria
    • Presence of severe osteoporosis (T-score less than -4.0)
    • Presence of Dorr C-type geometric change of the proximal femur
    • Evidence of secondary osteoporosis
    • Clinical or laboratory evidence of hepatic disease
    • Laboratory evidence of hypocalcaemia
    • Vitamin D deficiency (serum 25-OH(D) < 12 ng/mL)
    • Disorders of parathyroid function
    • Uncontrolled hyperthyroidism or hypothyroidism
    • History of malignancy, radiotherapy or chemotherapy for malignancy (except basal cell carcinoma of the skin) within the last 5 years
    • History of osteonecrosis of the jaw
    • History of recent tooth extraction or other dental surgery and/or invasive dental work planned in the next 2 years
    • Severe asthma or chronic obstructive pulmonary disease
    • Use within 12 months of drugs that affect bone metabolism such as ant-osteoporotic agents (including SERMS), estrogens, testosterone, and anti-epileptics
    • Rheumatoid arthritis or any other inflammatory arthritis
    • History of skeletal disorder, such as Paget’s disease or osteomalasia
    • Alcohol abuse
    • General
    o Mental, neurological or other conditions that may affect the ability to perform functional or clinical assessments required by the protocol
    o Subjects with known sensitivity or intolerance to any of the products to be administered
    o Subject will not be available for protocol-required study visits, to the best of the subject’s and investigator’s knowledge
    o Any other condition that, in the judgement of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures
    • Vaikea osteoporoosi (T-score alle -4.0)
    • Dorr C tyyppinen reisiluun yläosan muoto
    • Sekundaarinen osteoporoosi
    • Maksasairaus
    • Hypocalcaemia
    • D-vitamiinin puutostila
    • Lisäkilpirauhasen sairaus
    • Hoitamaton kilpirauhasen sairaus
    • Aiemmin sairastettu syöpä/sädehoito/sytostaattihoito
    • Leukaluun verenkiertohäiriö
    • Tuore hampaanpoisto tai odotettavissa oleva hammaskirurginen toimenpide
    • Vaikea astma tai keuhkoahtaumasairaus
    • Luustoon vaikuttavien lääkeaineiden käyttö viimeisen 12 kk aikana
    • Nivelreuma tai muu tulehduksellinen nivelsairaus
    • Luustosairaus, kuten Pagetin tauti tai osteomalasia
    • Alkoholin liikakäyttö
    • Muita syitä
    o Mielenterveysongelma tai toiminnallinen vika, joka vaikeuttaa tutkimusmenetelmien soveltamista toipumisen arvioinnissa
    o Lääkeaine tai muu allergia
    o Epävarmuus potilaan osallistumisesta pitkäaikaisseurantaan
    o Muu syy, joka tutkijan mielestä voi vaikeuttaa henkilön osallistumista tutkimukseen
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the percent change from baseline in periprosthetic BMD of the proximal femur
    Luuntiheyden muutos lonkkaproteesin reisikomponentin ympärillä
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 weeks
    48 viikkoa
    E.5.2Secondary end point(s)
    The change from baseline in three-dimensional translational and rotatory migration of the femoral stem
    Lonkan tekonivelen reisikomponentin mikroliike seurannan aikana
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 weeks
    48 viikkoa
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.2.4Number 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 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
    LVLS
    Viimeisen potilaan viimeinen käynti
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 68
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state68
    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)
    All patients will receive adequate osteoporosis treatment after the trial period (48 weeks)
    Kaikki potilaat saavat asianmukaisen osteoporoosihoidon tutkimuksen päätyttyä
    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 Decision2013-09-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-20
    P. End of Trial
    P.End of Trial StatusOngoing
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