Physiotherapy, Nutritional Supplement and Anabolic Steroids in Rehabilitation of Patients With Hip Fracture.

NCT03545347 | Completed Phase 2 DMC

• 2 other identifiers: HvidovreUH-HIP-SAP-12017-001543-13
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Fractures

Keywords

Rehabilitation; Physiotherapy; Strength training; Anabolic steroids; Nutritional supplement

Outcome Measures

Primary Outcomes (1)

• Change in maximal isometric knee-extension strength (Nm/Kg) in the fractured limb.

  Measured using a belt fixed handheld dynamometer.

  Baseline and 14 weeks after inclusion

Secondary Outcomes (44)

• Maximal isometric knee-extension strength (Nm/Kg) in the fractured limb in % of the non-fractured limb

  Baseline and 14 weeks after inclusion

• Maximal isometric knee-extension strength (Nm/Kg) in the non-fractured limb.

  Baseline and 14 weeks after inclusion.

• Hand-grip strength in the dominant hand.

  Baseline and 14 weeks after inclusion.

• Bone mineral density (BMD)

  Baseline and 14 weeks after inclusion.

• Lean body mass (LBM)

  Baseline and 14 weeks after inclusion.

Study Arms (2)

Nandrolone Decanoate

EXPERIMENTAL

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

Drug: Nandrolone Decanoate; Dietary Supplement: Protein-rich nutritional supplement; Other: Physical therapy

Placebo (Sodium Chloride)

PLACEBO COMPARATOR

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

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

Interventions

Nandrolone Decanoate DRUG

Injections every 3 weeks, last injection at week 12. Women 50 mg, men with total testosterone ≥ 11 nmol/l will receive 100 mg, and men with total testosterone \< 11 nmol/l will receive a dose of 200 mg.

Also known as: Deca-durabolin, anabolic steroid

Nandrolone Decanoate

Protein-rich nutritional supplement DIETARY_SUPPLEMENT

The protein-rich nutritional supplement is a liquid containing 18 g milk-based protein pr bottle. Patients will receive a minimum of 1.35 g/kg bodyweight/day); which means that most patients will receive 2 bottles per day for 12 weeks.

Also known as: Nestle Resource fiber 2.0

Nandrolone Decanoate; Placebo (Sodium Chloride)

Physical therapy OTHER

The physical therapy intervention will include progressive strength training initiated daily on weekdays during hospitalization and continued twice per week in the outpatient rehabilitation program in the municipality (treatment as usual but with strength training as an obligatory component) for a total intervention period of 12 weeks from time of inclusion.

Also known as: Physiotherapy

Nandrolone Decanoate; Placebo (Sodium Chloride)

Sodium Chloride 9mg/ml Injection DRUG

Placebo injection of 1 ml Sodium Chloride

Also known as: Saline

Placebo (Sodium Chloride)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Morten Tange Kristensen PT, PhD: lead

Study Sites (1)

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (2)

• Hulsbaek S, Bandholm T, Ban I, Foss NB, Jensen JB, Kehlet H, Kristensen MT. Feasibility and preliminary effect of anabolic steroids in addition to strength training and nutritional supplement in rehabilitation of patients with hip fracture: a randomized controlled pilot trial (HIP-SAP1 trial). BMC Geriatr. 2021 May 20;21(1):323. doi: 10.1186/s12877-021-02273-z.

  PMID: 34016037 DERIVED

• Hulsbaek S, Ban I, Aasvang TK, Jensen JB, Kehlet H, Foss NB, Bandholm T, Kristensen MT. Preliminary effect and feasibility of physiotherapy with strength training and protein-rich nutritional supplement in combination with anabolic steroids in cross-continuum rehabilitation of patients with hip fracture: protocol for a blinded randomized controlled pilot trial (HIP-SAP1 trial). Trials. 2019 Dec 23;20(1):763. doi: 10.1186/s13063-019-3845-y.

  PMID: 31870451 DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

Nandrolone Decanoate; Nandrolone; Anabolic Androgenic Steroids; Physical Therapy Modalities; Sodium Chloride

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Therapeutics; Rehabilitation; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Morten T Kristensen, PT, PhD

  Department of Occupational and Physical Therapy and Department of Orthopedic Surgery, Amager-Hvidovre University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 4, 2018
• Study Start: September 3, 2018
• Primary Completion: May 20, 2020
• Study Completion: June 3, 2020
• Last Updated: February 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)