Physiotherapy, Nutritional Supplement and Anabolic Steroids in Rehabilitation of Patients With Hip Fracture. (HIP-SAP)

Morten Tange Kristensen PT, PhD

Status and phase: Completed; Phase 2

Conditions: Hip Fractures

Treatments: Other: Physical therapy; Drug: Nandrolone Decanoate; Drug: Sodium Chloride 9mg/ml Injection; Dietary Supplement: Protein-rich nutritional supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT03545347

HvidovreUH-HIP-SAP-1

2017-001543-13 (EudraCT Number)

Details and patient eligibility

About

This pilot trial investigates the preliminary effect and safety of a 12 week multi-modal intervention initiated during admission in the acute ward after hip fracture surgery. The intervention under investigation is a combination therapy consisting of physiotherapy, protein-rich nutritional supplement and nandrolone decanoate (Deca-Durabolin) supplement. The investigators expect the combination therapy to be a preliminary effective and safe treatment in elderly patients with hip fracture and that this combination therapy intervention program is more efficacious in improving muscle strength, and physical function 14 weeks after hip fracture surgery, compared to physiotherapy, protein-rich nutritional supplement plus placebo.

Enrollment: 29 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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 >=60 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)

Exclusion criteria

• Postoperative weight-bearing restrictions
• Multiple fractures
• Active cancer or suspected pathological fracture
• Patients unable/unwilling to cooperate to 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 (disoriented, 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 assesed at the 3 week control 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) or milk protein allergy (related to the nutritional drink).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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29 participants in 2 patient groups, including a placebo group

Nandrolone Decanoate

Experimental group

Description:

Physical therapy with strength training, protein-rich nutritional supplement plus Nandrolone decanoate.

Treatment:

Dietary Supplement: Protein-rich nutritional supplement

Drug: Nandrolone Decanoate

Other: Physical therapy

Placebo (Sodium Chloride)

Placebo Comparator group

Description:

Physical therapy with strength training, protein-rich nutritional supplement plus placebo.

Treatment:

Dietary Supplement: Protein-rich nutritional supplement

Drug: Sodium Chloride 9mg/ml Injection

Other: Physical therapy