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    Summary
    EudraCT Number:2016-003110-27
    Sponsor's Protocol Code Number:21.07.2016
    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:2016-07-22
    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 number2016-003110-27
    A.3Full title of the trial
    Bone turnover markers as predictors of treatment break outcome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Bone turnover markers as predictors of treatment break outcome
    A.4.1Sponsor's protocol code number21.07.2016
    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 SponsorBente Lomholt Langdahl, Dept. of Endocrinology and Internal Medicine, Aarhus 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 supportThe P. Carl Petersen's Foundation
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDept. of Endocrinology and Internal Medicine, Aarhus University Hospital
    B.5.2Functional name of contact pointBente Lomholt Langdahl
    B.5.3 Address:
    B.5.3.1Street AddressTage-Hansens Gade 2
    B.5.3.2Town/ cityAarhus C
    B.5.3.3Post code8000
    B.5.3.4CountryDenmark
    B.5.6E-mailbenlan@rm.dk
    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 Alendronate
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen 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.3.1Product nameAlendronate
    D.3.2Product code M 05 BA 04
    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 INNbisphosphonates
    D.3.9.1CAS number 137504-90-6
    D.3.9.3Other descriptive nameALENDRONATE CALCIUM
    D.3.9.4EV Substance CodeSUB121114
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Osteoporosis
    E.1.1.1Medical condition in easily understood language
    Osteoporosis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10031289
    E.1.2Term Osteoporosis, unspecified
    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 investigate the predictive value of markers of bone turnover on bone loss 12 months after stopping alendronate therapy.
    Primary endpoint: To investigate to what extent changes in carboxy- terminal collagen crosslinks (CTX) 3 and 6 months after stopping alendronate treatment predict changes in total hip BMD after 1 year.
    E.2.2Secondary objectives of the trial
    Secondary endpoints:
    - To investigate to what extent baseline CTX when stopping
    alendronate treatment predicts changes in total hip BMD after 1 year.
    - To investigate to what extent changes in procollagen type I N- terminal propeptide (PINP) 3 and 6 months af-ter stopping alendronate treatment predict changes in total hip BMD after 1 year.
    - To investigate to what extent changes in the ratio CTX/PINP 3/6 months after stopping alendronate treatment predict changes in total hip BMD after 1 year.
    - The proportion of the study population in which bone turnover increases to above premenopausal/young adult reference levels after 3, 6, and 12 months.
    - The proportion of the study population who loses BMD beyond least significant change in lumbar spine and total hip.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    • Postmenopausal women (postmenopausal for at least two years)
    • Men above 50 years
    • Treatment for at least five years with alendronat
    • BMD T-score total hip > -2.5
    • BMD T-score lumbar spine (L1-L4) > -4
    E.4Principal exclusion criteria
    Exclusion criteria:
    • Any low-energy fracture within the previous 5 years during
    alendronat treatment (not including fingers, toes, or skull)
    • Low-energy vertebral fracture at any time
    • Low-energy hip fracture at any time
    • Ongoing treatment with glucocorticoids
    • Metabolic bone disease
    • Hormone replacement therapy
    • Cancer
    • Other conditions affecting bone metabolism
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    To investigate to what extent changes in carboxy-terminal collagen
    crosslinks (CTX) 3 and 6 months after stopping alendronate treatment predict changes in total hip BMD after 1 year.
    E.5.1.1Timepoint(s) of evaluation of this end point
    To investigate to what extent changes in carboxy-terminal collagen crosslinks (CTX) 3 and 6 months after stopping alendronate treatment predict changes in total hip BMD after 1 year.
    E.5.2Secondary end point(s)
    Secondary endpoints:
    - To investigate to what extent baseline CTX when stopping
    alendronate treatment predicts changes in total hip BMD after 1 year.
    - To investigate to what extent changes in procollagen type I N- terminal propeptide (PINP) 3 and 6 months af-ter stopping alendronate treatment predict changes in total hip BMD after 1 year.
    - To investigate to what extent changes in the ratio CTX/PINP 3/6 months after stopping alendronate treatment predict changes in total hip BMD after 1 year.
    - The proportion of the study population in which bone turnover increases to above premenopausal/young adult reference levels after 3, 6, and 12 months.
    - The proportion of the study population who loses BMD beyond least significant change in lumbar spine and total hip.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - To investigate to what extent baseline CTX when stopping alendronate treatment predicts changes in total hip BMD after 1 year.
    - To investigate to what extent changes in PINP 3 and 6 months af-ter stopping alendronate treatment predict changes in total hip BMD after 1 year.
    - To investigate to what extent changes in the ratio CTX/PINP 3/6 months after stopping alendronate treatment predict changes in total hip BMD after 1 year.
    - The proportion of the study population in which bone turnover increases to above premenopausal/young adult reference levels after 3, 6, and 12 months.
    - The proportion of the study population who loses BMD beyond least significant change in lumbar spine and total hip.
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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
    Last visit of the last subject undergoing the trial.
    The study will be terminated for the individual participant if the investigator suspects that the participant will be at risk of serious, life-threatening events if he or she continues as part of the study. If the DXA scans show a rapidly declining BMD > 8% during the first 6 months, the study will be terminated for this participant and treatment for osteoporosis will be re-initiated.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 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 state140
    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)
    The patients will be referred to the outpatient clinic at Aarhus University Hospital or their GP after termination of the study.
    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 Decision2016-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-31
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