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.

Phase 1

• Conditions: Area of investigation is recovery of muscle strength and function following hip fracture surgery.; MedDRA version: 20.1Level: LLTClassification code 10017287Term: Fractured hipSystem Organ Class: 100000004863; MedDRA version: 20.1Level: LLTClassification code 10017299Term: Fractured neck of femurSystem Organ Class: 100000004863; MedDRA version: 20.1Level: LLTClassification code 10034736Term: Pertrochanteric fracture of femur, closedSystem Organ Class: 100000004863; MedDRA version: 20.1Level: LLTClassification code 10053653Term: Femur fracture subtrochantericSystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2017-001543-13-DK
• Lead Sponsor: Morten Tange Kristensen/Hvidovre Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-01
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

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

•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, ?-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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified