E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Area of investigation is recovery of muscle strength and function following hip fracture surgery. |
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E.1.1.1 | Medical condition in easily understood language |
Area of investigation is recovery of muscle strength and function following hip fracture surgery. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10017287 |
E.1.2 | Term | Fractured hip |
E.1.2 | System Organ Class | 100000004863 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10017299 |
E.1.2 | Term | Fractured neck of femur |
E.1.2 | System Organ Class | 100000004863 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034736 |
E.1.2 | Term | Pertrochanteric fracture of femur, closed |
E.1.2 | System Organ Class | 100000004863 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053653 |
E.1.2 | Term | Femur fracture subtrochanteric |
E.1.2 | System Organ Class | 100000004863 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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)
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E.4 | Principal 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).
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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 |
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E.5.2.1 | 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) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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
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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. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |