Area of investigation is recovery of muscle strength and function following hip fracture surgery. MedDRA version: 20.1 Level: LLT Classification code 10017287 Term: Fractured hip System Organ Class: 100000004863 MedDRA version: 20.1 Level: LLT Classification code 10017299 Term: Fractured neck of femur System Organ Class: 100000004863 MedDRA version: 20.1 Level: LLT Classification code 10034736 Term: Pertrochanteric fracture of femur, closed System Organ Class: 100000004863 MedDRA version: 20
Conditions
Interventions
Trade Name: Deca-Durabolin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Nandrolone decanoate
Other descriptive name: NANDROLONE DECANOATE
Concentration unit: mg/ml milligram(s)/mi
Sponsors
Morten Tange Kristensen/Hvidovre Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 48
Exclusion criteria
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 200µmol/L) • Abnormal liver function tests (alanine aminotransferase, ?-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 70 years). • Allergic to any ingredient in the Deca-Durabolin solution (Nandrolone, benzyl alcohol, arachis oil (peanut-oil) and allergy to peanuts or soya).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Not applicable;Primary 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. ;Timepoint(s) of evaluation of this end point: 14 weeks after inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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;Timepoint(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) | — |
Countries
Denmark
Contacts
Public ContactMorten Tange Kristensen
Amager-Hvidovre Hospital
Outcome results
None listed