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    Summary
    EudraCT Number:2012-001249-41
    Sponsor's Protocol Code Number:KEK-ZH-2012-0249
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-10-29
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-001249-41
    A.3Full title of the trial
    Vitamin D3 – Omega3 – Home Exercise – HeALTHy Ageing and Longevity
    Trial Randomized, double-blind, placebo-controlled, multi-centre clinical
    trial
    Vitamin D3 – Omega3 – Heimtrainingsprogramm – gesundes Altern und
    Langlebigkeit
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    study for healthy ageing
    Studie zum gesunden Altern
    A.3.2Name or abbreviated title of the trial where available
    DO – HEALTH
    DO – HEALTH
    A.4.1Sponsor's protocol code numberKEK-ZH-2012-0249
    A.5.4Other Identifiers
    Name:FP7 Grant AgreementNumber:278588
    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 SponsorUniversity Hospital of Zurich and City Hospital Waid
    B.1.3.4CountrySwitzerland
    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 supportEuropean Commission FP7
    B.4.2CountryEuropean Union
    B.4.1Name of organisation providing supportNestle Nutrition
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportDMS Nutrition Products
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportRoche Diagnostics
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportBiomedica Medizinprodukte
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital of Zurich and City Hospital Waid
    B.5.2Functional name of contact pointHeike A. Bischoff-Ferrari
    B.5.3 Address:
    B.5.3.1Street AddressGloriastrasse 25
    B.5.3.2Town/ cityZürich
    B.5.3.3Post code8091
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041442552699
    B.5.5Fax number0041442559618
    B.5.6E-mailheikeabischoff@aol.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 No
    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 nameVitamin D3
    D.3.2Product code 5011574
    D.3.4Pharmaceutical form Capsule, soft
    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 INNCOLECALCIFEROL
    D.3.9.1CAS number 67-97-0
    D.3.9.4EV Substance CodeSUB06794MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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.IMP: 2
    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 No
    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 nameomega-3-Fatty-acids
    D.3.4Pharmaceutical form Capsule, soft
    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 INNOmega-3 docosalhexaenoic acid (DHA) and eicosapentaenoic acid (EPA)
    D.3.9.3Other descriptive nameOMEGA-3-ACID TRIGLYCERIDES
    D.3.9.4EV Substance CodeSUB12189MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,5
    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 Yes
    D.3.11.13.1Other medicinal product typenutritional oil derived from the marine alga
    D.IMP: 3
    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 No
    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 nameVitamin D3 / Omega-3-Fatty-acids
    D.3.4Pharmaceutical form Capsule, soft
    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 INNCOLECALCIFEROL
    D.3.9.1CAS number 67-97-0
    D.3.9.4EV Substance CodeSUB06794MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOmega-3 docosalhexaenoic acid (DHA) and eicosapentaenoic acid (EPA)
    D.3.9.3Other descriptive nameOMEGA-3-ACID TRIGLYCERIDES
    D.3.9.4EV Substance CodeSUB12189MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,5
    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 Yes
    D.3.11.13.1Other medicinal product typenutritional oil derived from the marine alga
    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 placeboCapsule, soft
    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
    healthy ageing, functional decline
    Gesundes Altern, altersbezogene chronische Erkrankungen
    E.1.1.1Medical condition in easily understood language
    healthy ageing, functional decline
    Gesundes Altern, altersbezogene chronische Erkrankungen
    E.1.1.2Therapeutic area Not possible to specify
    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
    Broad Goals
    The DO-HEALTH trial is designed to establish evidence for the role of
    vitamin D, omega-3 fatty acids, and a simple exercise program, both
    individually and as a combined intervention, in chronic disease
    prevention at older age.
    Objectives
    Main Objectives:
    • To improve healthy ageing in European seniors
    • To reduce healthcare costs via the implementation of effective and broadly applicable disease prevention interventions
    Umfassendes Ziel
    Die DO-HEALTH-Studie wurde entwickelt, um eine definitive Evidenz bzgl. der Wirkung von Vitamin D, Omega-3-Fettsäuren, und einem einfachen Trainingsprogramm, individuell und kombiniert, auf die Prävention von chronischen Krankheiten bei älteren Menschen, zu etablieren.
    Langfristige Ziele
    • Förderung der Gesundheit bei älteren Menschen in Europa
    • Gesundheitskosten senken durch Umsetzung von wirksamen u. breit anwendbaren Interventionen zur Prävention chonischer Erkrankungen
    E.2.2Secondary objectives of the trial
    Scientific Objectives:
    • To test whether 2000 IU vitamin D reduces risk of chronic disease in seniors compared to placebo
    • To test whether 1 g of marine omega-3 fatty acids (EPA+DHA) reduces the risk of chronic disease in seniors compared to placebo
    • To test whether a simple home exercise program reduces the risk of chronic disease in seniors compared to control (sham exercise performed 30 minutes 3 times a week)
    • To test whether there is an additive value of the 3 interventions combined as a multi-modal intervention in the reduction of chronic disease in seniors
    • To assess the comparative effectiveness of the interventions and to test whether and to what degree adherence modulates the effect of the 3 interventions on risk reduction of chronic disease in seniors
    • To assess the cost-benefit of the 3 interventions individually and in combination as a multi-modal intervention based on an objective health economic mode
    Wissenschaftliche Ziele sind:
    • zu untersuchen ob 2000 IE Vitamin D das Risiko von chronischen Krankheiten bei Senior/-innen im Vergleich zu Plazebo senkt
    • zu untersuchen ob 1g Omega-3-Fettsäuren (EPA + DHA) das Risiko von chronischen Krankheiten bei Senior/-innen im Vergleich zu Plazebo senken
    • zu untersuchen ob ein einfaches Heim-Trainingsprogramm das Risiko von chronischen Krankheiten bei Senior/-innen im Vergleich zu einem Kontrolle-Trainingsprogram senkt
    •zu untersuchen ob die 3 Interventionen, kombiniert als multi-modale Intervention, einen Mehrwert bei der Senkung von chronischen Erkrankungen bei Senioren/-innen bieten
    • zu untersuchen inwieweit die vergleichende Wirksamkeit und Adhärenz die risikosenkende Wirkung der Interventionen bei Senioren/-innen beeinflussen
    • zu untersuchen ob die 3 Interventionen, einzeln sowie als multi-modale kombinierte Intervention, Gesundheitskosten senken können aufgrund eines objektiven gesundheitsökonomischen Modells
    u. a.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Fracture Healing study, 02.07.2012, version 1.
    Fracture healing is a novel endpoint and DO-HEALTH will be one of the first RCTs to assess fracture healing at 3 levels in individuals with incident major osteoporotic fractures at the arm (shoulder, humerus, forearm) and leg (hip, femur, ankle): (a) primary fracture healing endpoint: clinical fracture healing with 3 additional phone calls at 6, 12, 18 weeks after the fracture assessing the PROMIS-HAQ (b) secondary fracture healing endpoint: observed functional fracture healing measured with the Short Physical Performance Test Battery and grip strength at regular 12, 24, 36 month visits (c) exploratory fracture healing endpoint: radiological fracture healing with independent assessment of early (6-8 weeks) and late (12 to 14 weeks) consolidation assessment based on standard x-rays.
    E.3Principal inclusion criteria
    - Mini Mental State Examination Score of at least 24
    - Living in the community
    - Sufficiently mobile to come to the study centre, to walk 10 meters with or without walking aid and to get in and out of a chair without help
    - Able to swallow study medication
    - Able and willing to participate, sign informed consent (including
    consent to analyze all samples until withdrawal) and cooperate with
    study procedures
    - Männer und Frauen ≥70 Jahre
    - Studienteilnehmer lebt selbständig im eigenen Haushalt
    - Studienteilnehmer ist in der Lage
    - die Studie zu verstehen
    - eine schriftliche Einverständniserklärung selbständig zu geben
    - die Studienmedikamente einzunehmen
    - die neuromusklären Tests (SPPB) ohne Gehhilfe durchzuführen
    - zum Studienzentrum zu kommen
    - MMSE von ≥ 24
    - 50% der Teilnehmer müssen einen „low-Trauma" Sturz mit oder ohne Fraktur aufweisen
    E.4Principal exclusion criteria
    (1) Consumption of more than 1000 IU vitamin D/day in the 6 month prior to enrolment, and/or a bolus of 300'000 IU vitamin D or more in the 12 month prior to enrolment, and /or unwillingness to limit vitamin D intake to the current standard of 800 IU/day of vitamin D during the course of the trial
    (2) Unwillingness to limit calcium supplement dose to 500 mg per day for the duration of the trial
    (3) Taking omega-3 fat supplements and unwilling to forgo their use for the duration of the trial
    (4) Use of any active vitamin D metabolite (i.e. Rocaltrol,
    alphacalcidiol), PTH treatment (i.e. Teriparatide), or Calcitonin at
    baseline and unwillingness to forego these treatments during the
    course of the trial
    (5) Current or recent (previous 4 months) participation in another clinical trial, or plans of such participation in the next 3 years (corresponding to DO-HEALTH length)
    (6) Presence of the following diagnosed health conditions in the last 5 years: history of cancer (except non-melanoma skin cancer); myocardial infarction, stroke, transient ischemic attack, angina pectoris, or coronary artery intervention
    (7) Severe renal impairment (creatinine clearance ≤ 15 ml/min) or
    dialysis, hypercalcaemia (> 2.6 mmol/l)
    (8) Hemiplegia or other severe gait impairment
    (9) History of hypo- or primary hyper-parathyroidism
    (10) Severe liver disease
    (11) History of granulomatous diseases (i.e. tubercolosis, sarcoidosis)
    (12) Major visual or hearing impairment or other serious illness that would preclude participation
    (13) Living with a partner who is enrolled in DO-HEALTH (we exclude couples)
    (14) Living in assisted living situations or a nursing home
    (15) Temporary exclusion: acute fracture in the last 6 weeks
    (16) Epilepsy and/or use of anti-epileptic drugs
    (17) Individuals who fell more than 3 times in the last month
    (18) Osteodystrophia deformans (M. Paget, Paget's disease)
    - Einnahme von >1000 IU/d Vitamin D in den letzten 6 Monaten vor StudieneinschlussStudieneinschluss und/oder Boluseinnahme von 300'000 IU Vitamin D oder mehr 12 den 12 Monaten vor der
    Studieneinschluss und keine Bereitschaft, diese auf den momentanen Standard von 800 IU/d Vitamin D zu reduzieren
    - Calciumeinnahme > 500 mg/d und keine Bereitschaft, diese zu
    reduzieren
    - Einnahme von Fischöl- oder Omega-3-Fettsäuren und keine
    Bereitschaft, für die Dauer der Studie darauf zu verzichten
    - Behandlung mit aktivem Vitamin D, PTH oder Calcitonin zum Beginn der Studie und keine Bereitschaft, für die Studiendauer darauf zu verzichten
    - gleichzeitige Teilnahme an einer anderen klinischen Studie
    - Krebserkrankung (außer weißem Hautkrebs), Herzinfarkt,
    Schlaganfall, TIA, An-gina pectoris oder Eingriffe an den
    Koronararterien während der letzten 5 Jahre
    - schwere Niereninsuffizienz (Kreatinin Clearance ≤ 15 ml/min),
    Dialyse oder Hy-percalzämie (>2,6mmol/l)
    - Hemiplegie oder andere schwere Gehbehinderung
    - Hypo- oder primärer Hyperparathyroidismus
    - granulomatöse Erkrankungen (Tuberkulose, Sarkoidose)
    - schwere Lebererkrankung
    - starke Seh- oder Hörbehinderung
    - andere schwerwiegende Erkrankungen, die eine Studienteilnahme unmöglich machen
    - Teilnahme des Partners an der Studie
    - Leben in einem Pflegeheim
    - Vorübergehender Ausschluss: Fraktur in den letzten 6 Wochen
    - Epilepsie und/oder Einnahme von Antiepileptika
    - Personen welche im letzten Monat mehr als 3 mal gestürzt sind
    - Osteodystrophia deformans (M. Paget)
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints:
    (1) Bone: Incident non-vertebral fractures over 36 months (confirmed by X-ray or medical reports)
    (2) Muscle: Functional decline (assessed by Short Physical
    Performance Test Battery)
    (3) Cardiovascular: Systolic and diastolic blood pressure change
    (4) Brain: Cognitive decline (assessed by Mini Mental State
    Examination)
    (5) Immunity: rate of any infection
    Im Rahmen der DO-Health Studie soll der Fragestellung nachgegangen werden, ob Vitamin D, Omega 3 Fettsäure und ein einfaches Hausübungsprogramm, welches auf die Erhöhung der Muskelleistung ausgerichtet ist, allein oder als kombinierte Interventionen zur Prävention von chronischen Erkrankungen im Alter eingesetzt werden können bzw. ein gesundes Altern ermöglichen. In einer 3-jährigen multizentrischen europäischen klinischen Studie sollen die Langzeitwirksamkeit sowie Sicherheitsdaten für die drei Interventionen erhoben werden
    Primäre Endpunkte:
    (1) Knochen: Inzidenz nicht-vertebrale Frakturen über 36 Monate
    (bestätigt durch Röntgenuntersuchungen oder medizinische Berichte)
    (2) Muskulatur: Funktionsverminderung (bewertet anhand des Short Physical Performance Test Battery)
    (3) Herz-Kreislauf: Änderung des systolischen und diastolischen
    Blutdrucks
    E.5.1.1Timepoint(s) of evaluation of this end point
    The evaluation of the primary endpoints will perform at baseline and then at the annual visits including the final visit after three years. The numbers of infection will additional collect during the telephone calls every three months.
    Die Evaluation der primären Endpunkte findet zu Baseline und dann zu den jährlichen Visiten einschließlich beim letzten Studienbesuch nach 36 Monaten statt. Infektionen werden auch bei den dreimonatigen Telefonaten erfaßt.
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    To support the primary endpoints and extend to other organ systems:
    (1) Bone: incidence of hip fractures, incidence of new vertebral
    fractures (vertebral morphometry obtained with DEXA measurements), incidence of total fractures – (DEXA measurements), risk of bone mineral density decrease in the spine and hip (assessed by DEXA measurements)
    (2) Muscle: rate of falling (rate of any low trauma fall, rate of
    injurious falls, number of persons who fell), reaction time and grip
    strength, incidence of muscle mass decrease at the upper and lower extremities (DEXA measurements), musculoskeletal pain, dual tasking 10 meter gait speed
    (3) Cardiovascular: risk of incident hypertension
    (4) Brain: mental health decline, incident depression, dual tasking
    gait variability
    (5) Immunity: rate of any upper respiratory infection, incident flu-like illness, incident severe infections that lead to hospital admission
    (6) Bone/Cartilage: Arthritis: primary outcome for osteoarthritis will be severity of knee pain (KOOS) in those with symptomatic knee osteoarthritis, secondary outcomes for osteoarthritis will be: rate of knee buckling, NSAID use because of knee pain; number of joints with pain
    (7) Dental: decline in oral health, tooth loss
    (8) Gastro-intestinal: gastro-intestinal symptoms based on Rome III questionnaire
    (9) Glucose-metabolic: fasting glucose and insulin levels, QUICKI and HOMA index, body composition and increase in body fat in the trunk and extremities by DEXA
    (10) Kidney: decline in kidney function – by blood creatinine levels
    and estimated GFR
    (11) Global Health: quality of life, incident frailty, incident disability
    regarding activities of daily living, incident nursing home admissions, rate of acute hospital admissions, mortality
    Exploratory Endpoints:
    To support the primary endpoints, but have limited statistical power:
    (1) Bone: Incident repeat fractures (any non-vertebral in all
    participants, vertebral fractures and total fractures among participants with IDXA measurements). Ancillary fracture healing study in all seniors with an incident major osteoporotic fractures at the arm (shoulder, humerus, forearm) and leg (hip, femur, ankle): (a) primary fracture healing endpoint: clinical
    fracture healing (HAQ-Promis questionnaire), (b) secondary fracture healing endpoint: observed functional fracture healing measured with the Short Physical Performance Test Battery and grip strength, (c) exploratory fracture healing endpoint: radiological fracture healing with independent assessment of early and late consolidation assessment based on standard x-rays.
    (2) Muscle: incident sarcopenia, incident frailty, decline in physical
    activity
    (3) Cardiovascular: major cardiovascular events as a composite
    endpoint (any event: myocardial infarction, stroke, vascularization
    procedures of CABG and PCI, incident congestive heart disease,
    cardiovascular mortality); individual endpoints: myocardial infarction, stroke, incident congestive heart disease, and cardiovascular mortality
    (4) Brain: incident dementia
    (5) Immunity: incident cancer (any cancer, gastro-intestinal, breast
    cancer in women, prostate cancer in men); rate of implant infections
    after total hip or knee replacement (due to fracture or osteoarthritis);
    rate of gastro-intestinal infections
    (6) Bone/Cartilage-Arthritis: incident symptomatic knee
    osteoarthritis; incident symptomatic hip osteoarthritis, incident
    symptomatic hand osteoarthritis; composite endpoint: incident
    symptomatic knee, hip or hand osteoarthritis; severity of hip pain in
    those with prevalent symptomatic hip osteoarthritis, severity of hand
    pain in those with prevalent symptomatic hand osteoarthritis
    Sekundäre Endpunkte:
    Zur Unterstützung der primären Endpunkten und zur Ausweitung auf andere Organsysteme:
    (1) Knochen: Inzidenz von Hüftfrakturen, Inzidenz neuer
    Wirbelfrakturen (vertebrale Morphometrie anhand DEXA Messungen), Inzidenz aller Frakturen, Risiko der Knochendichte-Abnahme an der Wirbelsäule und an der Hüften (anhand DEXA-Messungen)
    (2) Muskulatur: Sturzrate (Rate aller Stürze mit minimalem Trauma, Sturzrate mit Verletzungen, Anzahl der gestürzten Personen), Reaktionszeit und Griffstärke, Inzidenz des Muskelmassenrückgangs an den oberen und unteren Extremitäten (DEXA-Messungen), muskuloskelettale Schmerzen, Dual-Tasking 10-Meter Gehgeschwindigkeit
    (3) Herz-Kreislauf: Risiko einer neuen Bluthochdruckerkrankung
    (4) Gehirn: Verminderung der mentalen Gesundheit, Inzidenz
    Depression, Zunahmen der Dual-Tasking-Gang Variabilität
    (5) Immunität: Rate aller Infektionen der oberen Atemwege,
    Häufigkeit von grippeähnlichen Erkrankung, Häufigkeit von schweren Infektionen, die zu Spitaleinweisungen führten
    (6) Knochen/Knorpel: Arthrose - der primäre Endpunkt für
    Arthrosestudie ist der Schweregrad von Knieschmerzen (KOOS) bei Patienten/-innen mit symptomatischer Kniearthrose; sekundäre Endpunkte der Arthrosestudie: Rate "Knee Buckling" (Wegsacken im Kniegelenk), die Rate der Anwendung von Nichtsteroidaler Antiphlogisika (Schmerzmittel) aufgrund von Knieschmerzen, Anzahl schmerzhafter Gelenke
    (7) Zahngesundheit: Abnahme der oralen Gesundheit (Fragebogen), Zahnverlust
    (8) Magen-Darm: gastrointestinale Symptome anhand des Rome III Fragebogens
    (9) Zuckerstoffwechsel: Nüchtern-Blutzucker und Insulinspiegel,
    QUICKI und HOMA, Körpermasse und Zunahme des Körperfetts zentral und an den Extremitäten gemessen durch DEXA
    (10) Nieren: Rückgang der Nierenfunktion – anhand des
    Blutkreatininspiegels und geschätzter GFR
    (11) Allgemeiner Gesundheitszustand: Lebensqualität, Inzidenz
    Gebrechlichkeit (Frailty), Abnahme in den Aktivitäten des täglichen
    Lebens (ADL), Inzidenz Pflegeheimeintritt, die Rate stationärer
    Spitaleinweisungen, Mortalität
    Explorative Endpunkte:
    Zur Unterstützung der primären Endpunkte, jedoch mit limitierter
    statistischer Aussagekraft:
    (1) Knochen: Inzidenz von Wiederholungsfrakturen (alle nichtvertebralen Frakturen bei allen Teilnehmenden, Wirbelkörperfrakturen und alle Frakturen bei den Teilnehmenden mit IDXA Messungen). Ergänzende Studie zur Frakturheilung bei allen SeniorInnen mit einer osteoporotischen Fraktur am Arm (Schulter, Oberarm, Unterarm) oder Bein (Hüfte, Oberschenkel, Sprunggelenk): (a) primärer Frakturheilungs-Endpunkt: klinische Frakturheilung (HAQ-Promis Fragebogen), (b) sekundärer Frakturheilungs-Endpunkt: beobachtete funktionelle Frakturheilung gemessen mit der Short Physical Performance Test-Batterie und der Griffkraft gemessen an den jährlichen Untersuchungstagen, (c) explorativer Frakturheilungs-
    Endpunkt: radiologische Frakturheilung gemessen mittels
    unabhängiger Beurteilung der frühen und späten Konsolidierung
    (Kallusbildung) basierend auf Standard-Röntgenaufnahmen.
    (2) Muskulatur: Inzidenz Sarkopenie, Inzidenz Gebrechlichkeit
    (Frailty), Rückgang der körperlichen Aktivität (Fragebogen NHS)
    (3) Herz-Kreislauf: Inzidenz schwerwiegende kardiovaskuläre
    Ereignisse als kombinierter Endpunkt (mindestens einer der folgenden Endpunkte: Herzinfarkt, Schlaganfall, Revaskularisierung (Koronararterienbypass und Perkutane Koronarintervention), kongestive Herzkrankheit, kardiovaskuläre Mortalität); Inzidenz einzelner Endpunkte: Herzinfarkt, Schlaganfall, kongestive Herzkrankheit, kardiovaskuläre Mortalität
    (4) Gehirn: Inzidenz Demenz
    (5) Immunität: Inzidenz von Krebserkrankungen (kombinierter
    Endpunkt: mindestens eine neue Krebserkrankung); Inzidenz einelner Krebserkrankungen: Magen-Darm-Krebs, Brustkrebs bei Frauen, Prostatakrebs bei Männern); Rate der Protheseninfekte nach komplettem Hüft- oder Kniegelenkersatz (aufgrund einer Fraktur oder Gelenksarthrose); Rate der Gastro-instestinalen Infekte (6) Knochen/Knorpel-Arthrose: Auftreten von symptomatischer Kniegelenksarthrose, Hüftgelenksarthrose, Handgelenksarthrose; kombinierter Endpunkt: Auftreten von symptomatischer Knie-, Hüft oder Handgelenksarthrose; Schweregrad der Hüftschmerzen bei PatientInnen mit vorbestehender symptomatischer Hüftgelenksarthrose, Schweregrad der Handschmerzen bei PatientInnen mit vorbestehender symptomatischer Handgeelnksarthrose
    E.5.2.1Timepoint(s) of evaluation of this end point
    during the clinical visits at Baseline and after 12, 24, 36 months, some of the secondary endspoints (falls, fracture, infections) are evaluate during the telephone call every three months
    während der klinischen Visiten zu Baseline und nach 12, 24 und 36 Monaten; einige der sekundären Endpunkte (z.B. Stürze, Frakuren, Infektionen u.a.) werden auch während der 3-monatigen Telefonate erhoben.
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Heimtrainingsprogramm
    Home Exercise
    E.8.2.4Number of treatment arms in the trial8
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Switzerland
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2152
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state350
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1150
    F.4.2.2In the whole clinical trial 2152
    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)
    None
    Nein
    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 Decision2013-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-25
    P. End of Trial
    P.End of Trial StatusOngoing
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