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Clinical Trial Results:
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 - a randomized controlled pilot trial. (The HIP-SAP trial)

Summary
EudraCT number	2017-001543-13
Trial protocol	DK
Global end of trial date	03 Jun 2020

Results information
Results version number	v1(current)
This version publication date	03 Apr 2021
First version publication date	03 Apr 2021
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

HIP-SAP

ISRCTN number

US NCT number

NCT03545347

WHO universal trial number (UTN)

Sponsor organisation name

Copenhagen University Hospital Amager-Hvidovre

Sponsor organisation address

Kettegård alle 30, Hvidovre, Denmark, 2650

Public contact

Morten Tange Kristensen, Amager-Hvidovre Hospital, 0045 38626191, morten.tange.kristensen@regionh.dk

Scientific contact

Morten Tange Kristensen, Amager-Hvidovre Hospital, 0045 38626191, morten.tange.kristensen@regionh.dk

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

01 Oct 2020

Is this the analysis of the primary completion data?

Yes

Primary completion date

03 Jun 2020

Global end of trial reached?

Yes

Global end of trial date

03 Jun 2020

Was the trial ended prematurely?

Yes

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.

Protection of trial subjects

The trial is conducted in accordance with the Helsinki declaration and have been approved by the Capital Region’s Research Ethics Committee (H-18004495)

Background therapy

Evidence for comparator

Actual start date of recruitment

14 May 2018

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Denmark: 23

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening and inclusion from 6th of June 2018 until 24th February 2020.

Screening details

717 patients were screened

Period 1 title

"overall trial" (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Are arms mutually exclusive

Yes

Nandrolone

Arm description

Nandrolone decanoate (Deca-Durabolin 50mg/ml)

Arm type

Experimental

Investigational medicinal product name

Deca-Durabolin

Investigational medicinal product code

PR1in

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

5 injection over 12 weeks (3 weeks intervals). Women received 50 mg per dose; men with total testosterone ≥ 11 nmol/l received 100 mg, and men with total testosterone < 11 nmol/l received a dose of 200 mg per dose.

Placebo

Arm description

Saline injection

Arm type

Placebo

Investigational medicinal product name

0.9% Sodium Chloride

Investigational medicinal product code

Other name

Pharmaceutical forms

Solvent for parenteral use

Routes of administration

Intramuscular use

Dosage and administration details

50 mg intramuscular injected

Number of subjects in period 1	Nandrolone	Placebo
Started	12	11
Completed	11	10
Not completed	1	1
Consent withdrawn by subject	1	1

Baseline characteristics

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Reporting group title

Nandrolone

Reporting group description

Nandrolone decanoate (Deca-Durabolin 50mg/ml)

Reporting group title

Placebo

Reporting group description

Saline injection

Reporting group values	Nandrolone	Placebo	Total
Number of subjects	12	11	23
Age categorical
Units: Subjects
In utero			0
Preterm newborn infants (gestational age < 37 wks)			0
Newborns (0-27 days)			0
Infants and toddlers (28 days-23 months)			0
Children (2-11 years)			0
Adolescents (12-17 years)			0
Adults (18-64 years)			0
From 65-84 years			0
85 years and over			0
Age continuous
Units: years
arithmetic mean (standard deviation)	73.5 ( 5.9 )	73.4 ( 7.7 )	-
Gender categorical
Units: Subjects
Female	9	9	18
Male	3	2	5
Fracture type
Units: Subjects
Intracapsular	9	7	16
Extracapsular	3	4	7
Type of syrgery
Units: Subjects
2 pins	0	1	1
Hemi/total arthroplasty	8	6	14
Dynamic hip screw	1	1	2
Intramedular hip screw	3	3	6
Walking aid
Units: Subjects
Indoor walking aid	0	1	1
Outdoor walking aid	2	2	4
No walking aid	10	8	18
Discharged home
Units: Subjects
Discharged home	11	10	21
discharged to rehabilitation	1	1	2
New Mobility Score
Units: points
arithmetic mean (standard deviation)	8.6 ( 0.8 )	8.5 ( 1.0 )	-
Length of stay
Units: days
median (inter-quartile range (Q1-Q3))	8 (6 to 9)	8 (7 to 9)	-
American Society of anestesiologist GRADE (ASA)
Units: point
arithmetic mean (standard deviation)	2.1 ( 0.7 )	1.9 ( 0.3 )	-

End points

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Reporting group title

Nandrolone

Reporting group description

Nandrolone decanoate (Deca-Durabolin 50mg/ml)

Reporting group title

Placebo

Reporting group description

Saline injection

Primary: Knee extension strength, non fractured leg

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End point title

Knee extension strength, non fractured leg

End point description

End point type

Primary

End point timeframe

Baseline to 14 weeks follow-up

End point values	Nandrolone	Placebo
Number of subjects analysed	11	10
Units: Nm/kg
arithmetic mean (confidence interval 95%)	0.28 (0.20 to 0.37)	0.13 (-0.07 to 0.32)

within group difference

Comparison groups

Nandrolone v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.05

Method

t-test, 2-sided

Confidence interval

Primary: Knee extension strength fractured leg

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End point title

Knee extension strength fractured leg

End point description

within group difference

End point type

Primary

End point timeframe

baseline to 14-week follow-up

End point values	Nandrolone	Placebo
Number of subjects analysed	11	10
Units: Nm/kg
arithmetic mean (confidence interval 95%)	0.61 (0.34 to 0.88)	0.50 (0.21 to 0.79)

Within-group differences

Comparison groups

Nandrolone v Placebo

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.05

Method

t-test, 2-sided

Confidence interval

Adverse events

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Timeframe for reporting adverse events

baseline until 16 weeks

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

Nandrolone

Reporting group description

Reporting group title

Placebo

Reporting group description

Serious adverse events	Nandrolone	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 12 (25.00%)	0 / 11 (0.00%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events	0	0
Injury, poisoning and procedural complications
Post procedural infection
subjects affected / exposed	1 / 12 (8.33%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
Hip related pain
Additional description: 24-hour hospital stay because of hip fracture-related pain, ex-ray showed slight compression of the fracture site as expected according to type of ostesynthesis.
subjects affected / exposed	1 / 12 (8.33%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Coronary artery stenosis
Additional description: preexisting coronary stenosis, treated with stent
subjects affected / exposed	1 / 12 (8.33%)	0 / 11 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Nandrolone	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	12 / 12 (100.00%)	11 / 11 (100.00%)
Injury, poisoning and procedural complications
Falls
subjects affected / exposed	0 / 12 (0.00%)	3 / 11 (27.27%)
occurrences all number	0	3
Cardiac disorders
Syncope
Additional description: Short fainting related mobilization
subjects affected / exposed	1 / 12 (8.33%)	0 / 11 (0.00%)
occurrences all number	1	0
Blood pressure abnormal
Additional description: slight increase
subjects affected / exposed	1 / 12 (8.33%)	0 / 11 (0.00%)
occurrences all number	1	0
Surgical and medical procedures
click sounds osteosynthesis material
Additional description: Stopped after 2 weeks
subjects affected / exposed	0 / 12 (0.00%)	1 / 11 (9.09%)
occurrences all number	0	1
delayed fracture heeling
subjects affected / exposed	1 / 12 (8.33%)	0 / 11 (0.00%)
occurrences all number	1	0
General disorders and administration site conditions
edema
Additional description: primarily operated leg
subjects affected / exposed	3 / 12 (25.00%)	0 / 11 (0.00%)
occurrences all number	3	0
Pain
Additional description: Pain related to surgical procedure
subjects affected / exposed	0 / 12 (0.00%)	5 / 11 (45.45%)
occurrences all number	0	5
Dizziness
subjects affected / exposed	1 / 12 (8.33%)	0 / 11 (0.00%)
occurrences all number	1	0
Weight decreased
subjects affected / exposed	0 / 12 (0.00%)	1 / 11 (9.09%)
occurrences all number	0	1
rash
subjects affected / exposed	0 / 12 (0.00%)	1 / 11 (9.09%)
occurrences all number	0	1
Gastrointestinal disorders
Constipation
subjects affected / exposed	1 / 12 (8.33%)	0 / 11 (0.00%)
occurrences all number	1	0
Nausea
subjects affected / exposed	1 / 12 (8.33%)	3 / 11 (27.27%)
occurrences all number	1	3
Ulcer
Additional description: history of previous ulcer
subjects affected / exposed	1 / 12 (8.33%)	0 / 11 (0.00%)
occurrences all number	1	0
Reproductive system and breast disorders
prostate-specific antigen increased
Additional description: slight increase, 3 weeks after normalized
subjects affected / exposed	1 / 12 (8.33%)	0 / 11 (0.00%)
occurrences all number	1	0
Hepatobiliary disorders
Liver parameters increased
subjects affected / exposed	1 / 12 (8.33%)	2 / 11 (18.18%)
occurrences all number	1	2
Skin and subcutaneous tissue disorders
Quinkes edema
Additional description: One episode, a pre-existing condition, and well treated.
subjects affected / exposed	0 / 12 (0.00%)	1 / 11 (9.09%)
occurrences all number	0	1
chronic leg ulcer
subjects affected / exposed	0 / 12 (0.00%)	1 / 11 (9.09%)
occurrences all number	0	1
pressure ulcer
subjects affected / exposed	1 / 12 (8.33%)	0 / 11 (0.00%)
occurrences all number	1	0
Renal and urinary disorders
Greenish urine
subjects affected / exposed	0 / 12 (0.00%)	1 / 11 (9.09%)
occurrences all number	0	1
Urinary tract infection
subjects affected / exposed	1 / 12 (8.33%)	1 / 11 (9.09%)
occurrences all number	1	1
Renal impairment
Additional description: preexisting condition
subjects affected / exposed	0 / 12 (0.00%)	1 / 11 (9.09%)
occurrences all number	0	1
Psychiatric disorders
Depressed mood
Additional description: Known condition prior to enrollment
subjects affected / exposed	0 / 12 (0.00%)	1 / 11 (9.09%)
occurrences all number	0	1
Endocrine disorders
cholesterol parameters increased
subjects affected / exposed	3 / 12 (25.00%)	2 / 11 (18.18%)
occurrences all number	3	2
increased sweating
subjects affected / exposed	1 / 12 (8.33%)	1 / 11 (9.09%)
occurrences all number	1	1
Hirsutism
Additional description: preexisting facial hirsutisme (upper lip) ferriman-gallwey score 1 incresed to slight at chin, still score 1.
subjects affected / exposed	1 / 12 (8.33%)	0 / 11 (0.00%)
occurrences all number	1	0
Libido increased
subjects affected / exposed	0 / 12 (0.00%)	1 / 11 (9.09%)
occurrences all number	0	1
Infections and infestations
infection cicatrice
Additional description: treated with antibiotics
subjects affected / exposed	1 / 12 (8.33%)	1 / 11 (9.09%)
occurrences all number	1	1
Viral infection (common cold)
subjects affected / exposed	2 / 12 (16.67%)	3 / 11 (27.27%)
occurrences all number	2	3
Herpes zoster cutaneous disseminated
subjects affected / exposed	1 / 12 (8.33%)	0 / 11 (0.00%)
occurrences all number	1	0

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
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 - a randomized controlled pilot trial. (The HIP-SAP trial)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Knee extension strength, non fractured leg

Primary: Knee extension strength, non fractured leg

Primary: Knee extension strength fractured leg

Primary: Knee extension strength fractured leg

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical trials

Clinical Trial Results: 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 - a randomized controlled pilot trial. (The HIP-SAP trial)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Knee extension strength, non fractured leg

Primary: Knee extension strength, non fractured leg

Primary: Knee extension strength fractured leg

Primary: Knee extension strength fractured leg

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
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 - a randomized controlled pilot trial. (The HIP-SAP trial)