Hip FracturesPhase 2HIP-SAPNCT03545347
Physiotherapy, Nutritional Supplement and Anabolic Steroids in Rehabilitation of Patients With Hip Fracture.
A Phase 2 study testing Nandrolone Decanoate, Protein-rich nutritional supplement and Physical therapy in people with Hip Fractures, run by Morten Tange Kristensen PT, PhD at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Nandrolone Decanoate, Protein-rich nutritional supplement and Physical therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Sep 2018to 3 Jun 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 16Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Effect and Safety of Physiotherapy With Strength Training and Protein-rich 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)
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
- Being tested
- Nandrolone Decanoate, Protein-rich nutritional supplement, Physical therapy, Sodium Chloride 9mg/ml Injection
- Keywords
- Rehabilitation, Physiotherapy, Strength training, Anabolic steroids, Nutritional supplement
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nandrolone DecanoateDrug
Also called Deca-durabolin, anabolic steroid
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.
Protein-rich nutritional supplementDietary supplement
Also called Nestle Resource fiber 2.0
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.
Physical therapyOther
Also called Physiotherapy
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.
Sodium Chloride 9mg/ml InjectionDrug
Also called Saline
Placebo injection of 1 ml Sodium Chloride
| Study group | Role | What they receive |
|---|---|---|
| Nandrolone Decanoate | Experimental | Physical therapy with strength training, protein-rich nutritional supplement plus Nandrolone decanoate. Receives: 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. Receives: Dietary Supplement: Protein-rich nutritional supplement; Other: Physical therapy; Drug: Sodium Chloride 9mg/ml Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximal isometric knee-extension strength (Nm/Kg) in the fractured limb.
Measured using a belt fixed handheld dynamometer.
Measured: 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
Measured using a belt fixed handheld dynamometer.
Measured: Baseline and 14 weeks after inclusion
Maximal isometric knee-extension strength (Nm/Kg) in the non-fractured limb.
Measured using a belt fixed handheld dynamometer.
Measured: Baseline and 14 weeks after inclusion.
Hand-grip strength in the dominant hand.
Measured using a handheld dynamometer, expressed in kg.
Measured: Baseline and 14 weeks after inclusion.
Bone mineral density (BMD)
Registration of total body, total hip, femoral neck, lumbar spine. Assessed by Dual-energy X-ray absorptiometry (DEXA), expressed in g/cm2. Further the T-score is registered. The DEXA is conducted in accordance with the department's standard procedures.
Measured: Baseline and 14 weeks after inclusion.
Lean body mass (LBM)
Registration of total body, legs bilaterally, arms bilaterally. Assessed by DEXA and expressed in kg.
Measured: Baseline and 14 weeks after inclusion.
Fat mass
Total body. Assessed by DEXA and expressed in kg.
Measured: Baseline and 14 weeks after inclusion.
Nutrition screening using the Mini Nutritional Assessment Short Form (MNA-SF).
Total score from 0-14 points, high scores indicating better nutritional status
Measured: Baseline (prefracture) and 14 weeks after inclusion.
Gait speed will be assessed using the 10 meter walk test (10mWT)
The results reported in meters walked per second (m/s).
Measured: Baseline and 14 weeks after inclusion.
Timed up and go test (TUG)
Performed using a 4 wheeled rollator and measured in seconds. The patient has to rise from a chair, walk 3 meters, turnaround, walk back and sit down.
Measured: Baseline and 14 weeks after inclusion.
The de Mortons Mobility Index (DEMMI)
Measures mobility and consists of 15 mobility items ranging from mobility in bed to dynamic balance. The test results in a total score from 0 to 100 with 100 representing the highest level of mobility.
Measured: Baseline and 14 weeks after inclusion.
Upright time
Assessed by using a body-worn accelerometer-based activity monitor (ActivePAL). The monitor will be attached to the thigh. The patient will wear the monitor for 7 days.
Measured: Measured from the time of the control week 12 and one week ahead.
Functional level is assessed by the New Mobility Score (NMS).
The patients are interviewed about walking ability indoor, outdoor and when shopping. the week prior to hospital admission. The total score range from 0 to 9. A Higher score indicating higher independence.
Measured: Baseline (prefracture) and 3/6/9/12/14 weeks after inclusion.
The EQ-5D-3L is used for assessing health related quality of life.
It is administered via interview.
Measured: Baseline (prefracture) and 14 weeks after inclusion
Hip fracture related pain at rest and during outcome assessment
It is evaluated by Verbal Ranking Scale (VRS). The patient expresses pain levels on a verbal scale from 0-4, higher score indicating higher pain levels.
Measured: Baseline and 3/6/9/12/14 weeks after inclusion.
Global Rating of Change Scale
Assessment of patient perceived change in walking ability during the trial period.
Measured: Baseline, and 3/6/9/12/14 weeks after inclusion.
The Short Falls Efficacy Scale-International (Short FES-I)
Measures the patient's fear of falling (Score 7-28, higher scores indicating a higher fear of falling). It is administered as an interview.
Measured: Baseline and 14 weeks after inclusion.
Fatigue is assessed using the Short Form (36) Health Survey (SF36) vitality subscale.
The scale consists of 4 items related to fatigue/energy. Score range from 0-100 points; high score defines a more favorable health state. Administered as an interview.
Measured: Baseline (prefracture), and 3/6/9/12/14 weeks after inclusion.
Depression is assessed using the Geriatric Depression Scale (GDS-15)
Administered as an interview. Score range 0-15.
Measured: Baseline (prefracture) and 14 weeks after inclusion.
Re-admissions
Assessed through the medical journal/interviews.
Measured: 14 weeks after inclusion.
Residential status (including home care)
Change in residential status and home care (help provided in the patients home). Assessed through the medical journal/interviews.
Measured: Baseline (prefracture) and 14 weeks after inclusion.
Mortality
Assessed through the medical journal/Danish civil register.
Measured: 14 weeks after inclusion.
Falls
Number of falls. Assessed through interviews
Measured: Assessed through weekly telephone interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.
Total testosterone (nmol/l)
Blood test
Measured: Baseline and 14 weeks after inclusion.
Luteinizing hormone (LH), IU/l
Blood test
Measured: Baseline and 14 weeks after inclusion.
Follicle-stimulating hormone (FSH) IU/l
Blood test
Measured: Baseline and 14 weeks after inclusion.
Sex hormone binding globulin (SHBG), nmol/l
Blood test
Measured: Baseline and 14 weeks after inclusion.
Lipid profile (Total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride) mmol/l.
Blood test
Measured: Baseline and 14 weeks after inclusion.
C-reactive protein (CRP), mg/l.
Blood test
Measured: Baseline and 14 weeks after inclusion.
Hematocrit (B-Erythrocyte, vol.fr.)
Safety parameter, blood test
Measured: Baseline, and 3/6/9/12/14 weeks after inclusion.
Hemoglobin
Safety parameter, blood test
Measured: Baseline, and 3/6/9/12/14 weeks after inclusion.
Creatinine
Safety parameter, blood test
Measured: Baseline, and 3/6/9/12/14 weeks after inclusion.
Carbamide
Safety parameter, blood test
Measured: Baseline, and 3/6/9/12/14 weeks after inclusion.
Sodium (Na+)
Safety parameter, blood test
Measured: Baseline, and 3/6/9/12/14 weeks after inclusion.
Potassium (K+)
Safety parameter, blood test
Measured: Baseline, and 3/6/9/12/14 weeks after inclusion.
Calcium
Safety parameter, blood test
Measured: Baseline, and 3/6/9/12/14 weeks after inclusion.
Liver tests (Albumin, Alanine aminotransferase (ALAT), γ-glutamyltransferase, Bilirubin)
Safety parameter, blood test
Measured: Baseline, and 3/6/9/12/14 weeks after inclusion.
International Normalized Ratio (INR)
Safety parameter, blood test
Measured: Baseline, and 3/6/9/12/14 weeks after inclusion.
Prostate Specific Antigen (PSA)
Safety parameter, blood test
Measured: Baseline, and 3/6/9/12/14 weeks after inclusion.
Glucose
Safety parameter, blood test
Measured: Baseline, and 3/6/9/12/14 weeks after inclusion.
Blood pressure
Safety parameter, assessed using a 'Blood pressure monitor' (mmHg).
Measured: Baseline, and 3/6/9/12/14 weeks after inclusion.
Facial hirsutism
Change in facial hair assessed using the 2 face-related items of Ferriman-Galway Hirsutism Score.
Measured: Baseline, and 3/6/9/12/14 weeks after inclusion.
Hoarseness
Change in voice, reported by patient or observed by interviewer (no specific score available for this evaluation).
Measured: Assessed at baseline and through weekly telephone interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.
Other adverse events
Assessed through interview, observation
Measured: Assessed through weekly interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.
Edema in non-fractured leg
Change in edema assessed through interview
Measured: Assessed at baseline and through weekly interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start3 Sep 2018
- Primary completion20 May 2020
- Study completion3 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morten Tange Kristensen PT, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Morten Tange Kristensen PT, PhD, Hvidovre University Hospital
- Investigators
- Morten T Kristensen, PT, PhD, Study director, Department of Occupational and Physical Therapy and Department of Orthopedic Surgery, Amager-Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545347
- Sponsor's protocol ID
- HvidovreUH-HIP-SAP-1
- Other IDs
- 2017-001543-13, 2017
- Acronym
- HIP-SAP
- Status last verified
- Feb 2021
- First submitted
- 18 May 2018
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34016037Hulsbaek 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.
PubMed 31870451
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Effect and Safety of Physiotherapy With Strength Training and Protein-rich 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)
- ClinicalTrials.gov ID
- NCT03545347
- Acronym / sponsor ID
- HIP-SAP / HvidovreUH-HIP-SAP-1
- Conditions
- Hip Fractures
- Keywords
- Rehabilitation, Physiotherapy, Strength training, Anabolic steroids, Nutritional supplement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Morten Tange Kristensen PT, PhDUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 3 Jun 2020 (actual)
- First posted
- 4 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nandrolone Decanoate | Experimental | Drug: Nandrolone Decanoate, Dietary Supplement: Protein-rich nutritional supplement, Other: Physical therapyPhysical therapy with strength training, protein-rich nutritional supplement plus Nandrolone decanoate. |
| Placebo (Sodium Chloride) | Placebo comparator | Dietary Supplement: Protein-rich nutritional supplement, Other: Physical therapy, Drug: Sodium Chloride 9mg/ml InjectionPhysical therapy with strength training, protein-rich nutritional supplement plus placebo. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nandrolone DecanoateAlso: Deca-durabolin, anabolic steroidInjections 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. | Drug | Nandrolone Decanoate |
| Protein-rich nutritional supplementAlso: Nestle Resource fiber 2.0The 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. | Dietary supplement | Nandrolone Decanoate, Placebo (Sodium Chloride) |
| Physical therapyAlso: PhysiotherapyThe 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. | Other | Nandrolone Decanoate, Placebo (Sodium Chloride) |
| Sodium Chloride 9mg/ml InjectionAlso: SalinePlacebo injection of 1 ml Sodium Chloride | Drug | Placebo (Sodium Chloride) |
Primary outcome
Change in maximal isometric knee-extension strength (Nm/Kg) in the fractured limb.
Time frame: Baseline and 14 weeks after inclusion
Measured using a belt fixed handheld dynamometer.
44 secondary outcomes
Maximal isometric knee-extension strength (Nm/Kg) in the fractured limb in % of the non-fractured limb
Time frame: Baseline and 14 weeks after inclusion
Maximal isometric knee-extension strength (Nm/Kg) in the non-fractured limb.
Time frame: Baseline and 14 weeks after inclusion.
Hand-grip strength in the dominant hand.
Time frame: Baseline and 14 weeks after inclusion.
Bone mineral density (BMD)
Time frame: Baseline and 14 weeks after inclusion.
Lean body mass (LBM)
Time frame: Baseline and 14 weeks after inclusion.
Fat mass
Time frame: Baseline and 14 weeks after inclusion.
Nutrition screening using the Mini Nutritional Assessment Short Form (MNA-SF).
Time frame: Baseline (prefracture) and 14 weeks after inclusion.
Gait speed will be assessed using the 10 meter walk test (10mWT)
Time frame: Baseline and 14 weeks after inclusion.
Timed up and go test (TUG)
Time frame: Baseline and 14 weeks after inclusion.
The de Mortons Mobility Index (DEMMI)
Time frame: Baseline and 14 weeks after inclusion.
Upright time
Time frame: Measured from the time of the control week 12 and one week ahead.
Functional level is assessed by the New Mobility Score (NMS).
Time frame: Baseline (prefracture) and 3/6/9/12/14 weeks after inclusion.
The EQ-5D-3L is used for assessing health related quality of life.
Time frame: Baseline (prefracture) and 14 weeks after inclusion
Hip fracture related pain at rest and during outcome assessment
Time frame: Baseline and 3/6/9/12/14 weeks after inclusion.
Global Rating of Change Scale
Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.
The Short Falls Efficacy Scale-International (Short FES-I)
Time frame: Baseline and 14 weeks after inclusion.
Fatigue is assessed using the Short Form (36) Health Survey (SF36) vitality subscale.
Time frame: Baseline (prefracture), and 3/6/9/12/14 weeks after inclusion.
Depression is assessed using the Geriatric Depression Scale (GDS-15)
Time frame: Baseline (prefracture) and 14 weeks after inclusion.
Re-admissions
Time frame: 14 weeks after inclusion.
Residential status (including home care)
Time frame: Baseline (prefracture) and 14 weeks after inclusion.
Mortality
Time frame: 14 weeks after inclusion.
Falls
Time frame: Assessed through weekly telephone interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.
Total testosterone (nmol/l)
Time frame: Baseline and 14 weeks after inclusion.
Luteinizing hormone (LH), IU/l
Time frame: Baseline and 14 weeks after inclusion.
Follicle-stimulating hormone (FSH) IU/l
Time frame: Baseline and 14 weeks after inclusion.
Sex hormone binding globulin (SHBG), nmol/l
Time frame: Baseline and 14 weeks after inclusion.
Lipid profile (Total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride) mmol/l.
Time frame: Baseline and 14 weeks after inclusion.
C-reactive protein (CRP), mg/l.
Time frame: Baseline and 14 weeks after inclusion.
Hematocrit (B-Erythrocyte, vol.fr.)
Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.
Hemoglobin
Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.
Creatinine
Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.
Carbamide
Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.
Sodium (Na+)
Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.
Potassium (K+)
Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.
Calcium
Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.
Liver tests (Albumin, Alanine aminotransferase (ALAT), γ-glutamyltransferase, Bilirubin)
Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.
International Normalized Ratio (INR)
Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.
Prostate Specific Antigen (PSA)
Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.
Glucose
Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.
Blood pressure
Time frame: Baseline, and 3/6/9/12/14 weeks after inclusion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Derived from this study: PubMed 34016037Hulsbaek 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.
- Derived from this study: PubMed 31870451Hulsbaek 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten T Kristensen, PT, PhD study director
Department of Occupational and Physical Therapy and Department of Orthopedic Surgery, Amager-Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nandrolone Decanoate, Protein-rich nutritional supplement and Physical therapy in people with Hip Fractures, run by Morten Tange Kristensen PT, PhD at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maximal isometric knee-extension strength (Nm/Kg) in the fractured limb. (time frame: Baseline and 14 weeks after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03545347, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.