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    Summary
    EudraCT Number:2017-001543-13
    Sponsor's Protocol Code Number:HIP-SAP
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-02-01
    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 number2017-001543-13
    A.3Full title of the trial
    Preliminary effect and safety of physiotherapy with strength training and protein-dense nutritional supplement in combination with anabolic steroids in cross-continuum rehabilitation of patients with hip fracture - a randomized controlled pilot trial. (The HIP-SAP trial)

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Preliminary effect and safety of physiotherapy with strength training and protein-dense nutritional supplement in combination with anabolic steroids in cross-continuum rehabilitation of patients with hip fracture.
    A.3.2Name or abbreviated title of the trial where available
    HIP-SAP trial
    A.4.1Sponsor's protocol code numberHIP-SAP
    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 SponsorMorten Tange Kristensen/Hvidovre 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 supportAmager-Hvidovre Hospital
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportCapital Regions Research Fund for Health Research
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportCapital Regions Cross-continuum Research Fund
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Danish Physiotherapy Associations Research Fund
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmager-Hvidovre Hospital
    B.5.2Functional name of contact pointMorten Tange Kristensen
    B.5.3 Address:
    B.5.3.1Street AddressKettegaard Allé 30
    B.5.3.2Town/ cityHvidovre
    B.5.3.3Post code2650
    B.5.3.4CountryDenmark
    B.5.4Telephone number004538626191
    B.5.6E-mailmorten.tange.kristensen@regionh.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 Deca-Durabolin
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Pharma Trading Limited
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNandrolone decanoate
    D.3.9.3Other descriptive nameNANDROLONE DECANOATE
    D.3.9.4EV Substance CodeSUB03384MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboSolvent for parenteral use
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Area of investigation is recovery of muscle strength and function following hip fracture surgery.
    E.1.1.1Medical condition in easily understood language
    Area of investigation is recovery of muscle strength and function following hip fracture surgery.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10017287
    E.1.2Term Fractured hip
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10017299
    E.1.2Term Fractured neck of femur
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10034736
    E.1.2Term Pertrochanteric fracture of femur, closed
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10053653
    E.1.2Term Femur fracture subtrochanteric
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this placebo controlled pilot trial is to determine the preliminary effect and safety of a 12 week multimodal intervention initiated during admission in the acute ward after hip fracture surgery. The intervention under investigation is a combination therapy consisting of physiotherapy (functional, balance and strength training), protein- dense nutritional supplement and nandrolone decanoate (Deca-Durabolin) supplement on improving the fractured limb knee-extension muscle strength at a 14 week follow-up.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients who have undergone surgery for a hip fracture at Amager-Hvidovre University Hospital and admitted at the Hip Fracture Unit at the hospital
    • Age >=65 years
    • Ability to speak and understand Danish and with a Danish Social Security Number
    • Able to give written informed consent
    • Residing at home and with an independent pre-fracture indoor walking ability (NMS≥2)

    E.4Principal exclusion criteria
    • Postoperative weight-bearing restrictions
    • Multiple fractures
    • Terminal illness
    • Patients unable/unwilling to cooperate on testing and rehabilitation
    • Planned/elective hospitalization within the trial period.
    • Cognitive dysfunction determined by chart review, reported by nursing staff, or observed by trained research staff (not alert or oriented, dementia, active delirium)
    • Uncontrolled blood pressure (systolic > 150 mmHg, or diastolic > 100 mmHg)
    • Heart disease in the form of peri-, myo- or endocarditis.
    • History of stroke with motor disability.
    • Heart failure (NYHA class III and IV)
    • Evidence of kidney failure or renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m2 or serum creatinine >200μmol/L)
    • Abnormal liver function tests (alanine aminotransferase, γ-glutamyltransferase, bilirubin, or alkaline phosphatase >2 times the upper limit of normal) or history of hepatic tumor.
    • Elevated hematocrit ≥ 50%
    • History of breast or prostate cancer
    • Abnormally elevated serum PSA corresponding to PSA < 4.0 µg/L (60–70 years), PSA < 5.0 µg/L (>70 years).
    • Allergic to any ingredient in the Deca-Durabolin solution (Nandrolone, benzyl alcohol, arachis oil (peanut-oil) and allergy to peanuts or soya).
    E.5 End points
    E.5.1Primary end point(s)
    • Change in maximal isometric knee-extension strength (Nm/Kg) in the fractured limb (Maximal Voluntary Torque (MVT) per kilo body mass) from baseline to the 14 week follow-up.
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 weeks after inclusion
    E.5.2Secondary end point(s)
    Hand Grip Strength
    Lower Limb Muscle Mass
    BMD (Bone mineral density)
    LBM (Lean body mass)
    Weight
    Nutritional status
    Gait speed
    Functional mobility
    Physical activity (Upright time)
    Functional level
    Health-related quality of life
    Hip fracture-related pain
    Fear of falling
    Fatigue
    Depression
    Re-admissions
    Residential status
    Mortality
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and 14 weeks after inclusion:
    Hand-grip strength
    Lower Limb Muscle Mass
    BMD (Bone mineral density)
    LBM (Lean body mass)
    Weight
    Nutritional status
    Gait speed
    Mobility
    Functional level
    Health-related quality of life
    Fear of falling
    Depression
    Re-admissions
    Residential status
    Mortality

    Baseline, 3, 6, 9, 12 and 14 weeks after inclusion:
    Hip fracture-related pain
    Fatigue
    Functional level

    During week 12:
    Physical activity (Upright time)
    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 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) 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 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
    Trial participation ends with a telephone interview during week 16 to ensure potential side effects are recorded and hereafter the patient will have no further obligations in relation to the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 state48
    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
    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 Decision2018-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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