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    Summary
    EudraCT Number:2015-003638-28
    Sponsor's Protocol Code Number:2015/576
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-08-28
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2015-003638-28
    A.3Full title of the trial
    ALOSTRA
    Alendronate treatment of osteoporosis in rheumatoid arthritis – indication and duration. A randomized, doubleblind, placebocontrolled multi-centre study to evaluate the effects of discontinuation of alendronate in patients with both rheumatoid arthritis and low bone mass.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of osteoporosis in patients with rheumatoid arthritis.
    Behandling af knogleskørhed hos patienter med leddegigt.
    A.3.2Name or abbreviated title of the trial where available
    ALOSTRA
    ALOSTRA
    A.4.1Sponsor's protocol code number2015/576
    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 SponsorAarhus University Hospital
    B.1.3.4CountryDenmark
    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 supportDanish Rheumatism Association
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportDanish Regions Medicine Fund
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe AP Møller Foundation for the Advancement of Science
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Danielsen Foundation
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus University Hospital
    B.5.2Functional name of contact pointReumatologisk Forskning
    B.5.3 Address:
    B.5.3.1Street AddressPalle Juul Jensens Boulevard 59, E290-130
    B.5.3.2Town/ cityAarhus N
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.6E-mailannebnie@rm.dk
    D. IMP Identification
    D.IMP: 1
    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 Alendronat "Teva"
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Denmark A/S
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNAlendronic Acid
    D.3.9.3Other descriptive nameALENDRONIC ACID
    D.3.9.4EV Substance CodeSUB05307MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.07
    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) 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 placeboCoated tablet
    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
    Rheumatoid arthritis and osteoporosis
    leddegigt og knogleskørhed
    E.1.1.1Medical condition in easily understood language
    rheumatoid arthritis and osteoporosis
    leddegigt og knogleskørhed
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10031289
    E.1.2Term Osteoporosis, unspecified
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10039076
    E.1.2Term Rheumatoid arthritis and other inflammatory polyarthropathies
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of discontinuation of alendronate on bone metabolism in patients with non-glucocorticoid treated rheumatoid arthritis and alendronate-treated osteoporosis with a current T-score in the range of osteopenia.
    - to assess the effect of discontinuation of ALN on C-terminal telopeptide crosslinks (CTX) and Type 1 procollagen amino-terminal-propeptide (P1NP) after 6 months
    - to assess the effect of discontinuation of ALN on BMD at 2 years
    E.2.2Secondary objectives of the trial
    - to assess the effect of discontinuation of ALN on vBMD at 2 years
    - to assess the effect of discontinuation of ALN on other biochemical markers of bone metabolism after 6, 12 and 24 months
    - to evaluate and compare the changes in vBMD in cancellous and cortical bone respectively, after discontinuation of ALN
    - to evaluate the correlation between RA activity and bone metabolism
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients (> 18 years) with rheumatoid arthritis according to the ACR/EULAR (2010) classification criteria (10)
    - patients must have been treated with oral bisphosphonatesalendronate for 5 years or longer, the last three years with alendronate
    - current T-score on DXA better than or equal to -2,5 (femoral) and -3,0 (vertebral)
    - receiving treatment on an outpatient basis
    - negative pregnancy test (serum HCG) prior to trial start and the use of contraception throughout the study period and for 1 month after conclusion of the study period for women of childbearing potential. Plasma T1/2 of ALN is less than 2 hours. The forms of contraception include: intrauterine device (IUD) and hormonal anticontraceptives (contraceptive pill, implant, patch or injection or vaginal ring). Sterile and non-fertile participants do not have to use contraception. Sterile or non-fertile is defined as having undergone surgical sterilization (vasectomy / bitalteral tubectomy, hysterectomy and bilateral ooferectomy) or post-menopausal status, defined as absence of menstrual period for at least 12 months prior to enrollment. Postmenopause will be confirmed by measurement of s-FSH prior to enrollment.
    - ability and willingness to give written informed consent and to meet the requirements of the trial protocol.
    E.4Principal exclusion criteria
    - history of hip fracture due to osteoporosis
    - - history of vertebral fragility fractures within the last three years OR fragility fractures in more than two vertebrae
    - - history of non-vertebral fragility fractures (fingers and toes not included) within the last three years
    - osteonecrosis of the jaw.
    - history of or ongoing systemic GC treatment within the last 6 months (intraarticular injections are approved)
    - known allergy toward any components of the study medicine
    - prior or ongoing treatment with with BPs other than ALN or other antiosteoporosis drugs such as hormone replacement therapy (HRT) or teriparatide (low-dose HRT up to 1mg/day is accepted)
    - evidence of active malignant disease
    - metabolic bone disease other than osteoporosis
    - hypo- or hyperthyroidism
    - hypocalcaemia
    - impaired renal function (eGFR <35ml/min)
    - known disease of the esophagus that might impair the ability to swallow the tablets such as achalasia, dysphagia or strictures
    - history of upper gastrointestinal disease within 1 year prior to enrollment such as peptic ulcer, upper GI bleeding, gastritis, duodenitis or surgical procedures to the upper GI-tract
    - allergy towards any of the substances in the study medicine

    E.5 End points
    E.5.1Primary end point(s)
    a) changes in serum CTX and P1NP from baseline 6 months
    b) changes in BMD from baseline to 2 years follow-up on DXA on left hip and spine ( vertebrae L2-L3)
    E.5.1.1Timepoint(s) of evaluation of this end point
    a) months 6
    b) months 24
    E.5.2Secondary end point(s)
    c) changes in vBMD from baseline to 2 years follow-up on HR-pQCT after 1 and 2 years in metacarpals 2-4 and at the distal radius
    d) changes from baseline to 6, 12 and 24 months in the following serological markers of bone metabolism and inflammation :
    - CTX
    - P1NP
    - Bone-specific alkaline phosphatase, (bsAP)
    - Tumor necrosis factor-alfa (TNF),
    - RANK-Ligand (RANK-L)
    - Osteoprotegrin (OPG)
    - Osteocalcin
    - Sclerostin,(SCL)
    - Interleukins, 6 and 17, (IL-6, IL-17)
    - C-reactive protein (CRP)
    e) changes in vBMD in cancellous and trabecular bone respectively from baseline to 2 years
    f) mean DAS-28-CRP throughout the study period (24 months)
    g) new erosions on X-ray according to the Sharp-van-der-Heijde-score
    E.5.2.1Timepoint(s) of evaluation of this end point
    c)months 12 and 24
    d)months 6, 12 and 24
    e)month 24
    f)month 24
    g)month 24
    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 Yes
    E.6.4Safety Yes
    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.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 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 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 concerned7
    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
    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 months8
    E.8.9.1In the Member State concerned days
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state160
    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)
    After completionm of the trial all participants will resume treatment with alendronate as before enrolment
    Efter deltagelse i forsøget genoptager deltagerne behandling med alendronat ligesom før deltagelse
    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 Decision2015-09-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-30
    P. End of Trial
    P.End of Trial StatusOngoing
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