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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02152761
Registration number
NCT02152761
Ethics application status
Date submitted
8/05/2014
Date registered
2/06/2014
Date last updated
19/08/2020
Titles & IDs
Public title
Study of Efficacy and Safety of Bimagrumab in Patients After Hip Fracture Surgery
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Scientific title
A 24-week Double-blind Treatment and 24-week Follow-up, Randomized, Multicenter, Placebo-controlled, Phase IIa/IIb Study to Evaluate Safety and Efficacy of i.v. Bimagrumab on Total Lean Body Mass and Physical Performance in Patients After Surgical Treatment of Hip Fracture
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Secondary ID [1]
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2013-003439-31
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Secondary ID [2]
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CBYM338D2201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Muscle Wasting (Atrophy) After Hip Fracture Surgery
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Diet and Nutrition
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Other diet and nutrition disorders
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Injuries and Accidents
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Fractures
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - bimagrumab
Other interventions - placebo
Experimental: bimagrumab 700 mg - Approximately 70 patients who met all inclusion criteria and none of the exclusion criteria were treated with the bimagrumab high dose administered via intravenous infusion starting Day 1 until Week 20
Experimental: bimagrumab 210 mg - Approximately 70 patients who met all inclusion criteria and none of the exclusion criteria were treated with the bimagrumab medium dose administered via intravenous infusion starting Day 1 until Week 20
Placebo Comparator: placebo - Approximately 70 patients who met all inclusion criteria and none of the exclusion criteria received matching placbo administered via intravenous infusion starting Day 1 until Week 20
Experimental: Bimagrumab 70 mg - Approximately 35 patients who met all inclusion criteria and none of the exclusion criteria were treated with bimagrumad low dose administered via intravenous infusion starting Day 1 until Week 20
Treatment: Drugs: bimagrumab
Bimagrumab was administered as intravenous infusion starting on Day 1 until week 20.
Other interventions: placebo
Matching placebo was administered as intravenous infusion starting on Day 1 until week 20.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Total Lean Body Mass Measured by DXA (Dual-energy X-ray Absorptiometry) at Weeks 12 and 24
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Assessment method [1]
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Mixed Model for Repeated Measures (MMRM) of change from baseline in total LBM (kg) by treatment and visit To assess dose-response relationship of bimagrumab and facilitate an adequate dose selection for future phase III studies, without the need for supportive data from another dose-response finding study, at least three doses were required, ranging from a non-effective or minimally effective dose to a dose where maximal efficacy is expected. Original study was initiated with only two doses of bimagrumab, therefore, a lower dose arm of 70mg has been added to this study with Amendment 2, changing the randomization ratio from 1:1:1 to 2:1:2:2 to either placebo, bimagrumab 70mg, bimagrumab 210mg, or bimagrumab 700mg. Since the 70mg dose was expected to show suboptimal efficacy and fewer patients were randomized to this group, it was used only for dose response modelling and not for hypothesis testing. Consequently, no efficacy evaluations for the bimagrumab 70mg Arm were performed
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Timepoint [1]
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baseline, weeks 12 and 24
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Secondary outcome [1]
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Change From Baseline in Gait Speed at Week 24 (Meters/Sec)
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Assessment method [1]
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Mixed Model for Repeated Measures (MMRM) of change from baseline in derived gait speed (m/sec) by treatment and visit
To assess dose-response relationship of bimagrumab and facilitate an adequate dose selection for future phase III studies, without the need for supportive data from another dose-response finding study, at least 3 doses were required, ranging from a non-effective or minimally effective dose to a dose where maximal efficacy is expected. Original study was initiated with only two doses of bimagrumab, therefore, a lower dose arm of 70mg was added to this study with Amendment 2, changing the randomization ratio from 1:1:1 to 2:1:2:2 to either placebo, bimagrumab 70mg, bimagrumab 210mg, or bimagrumab 700mg. Since the 70mg dose was expected to show suboptimal efficacy and fewer patients were randomized to this group, it was used only for dose response modelling and not for hypothesis testing. Consequently, no efficacy evaluations for the bimagrumab 70mg Arm were performed
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Timepoint [1]
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Baseline, Week 24
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Secondary outcome [2]
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Change From Baseline in Short Physical Performance Battery at Weeks 24
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Assessment method [2]
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MMRM change from baseline in total score by treatment & visit to Week 24 in physical performance measured by Short Physical Performance Battery (SPPB) that evaluates lower extremity function. Score range is 0 (worst performance) to 12 (best) to assess dose-response relationship of bimagrumab & facilitate adequate dose selection for future phase III studies, without need for supportive data from another dose-response finding study, at least 3 doses were required, ranging from non- or minimally effective dose to a dose where maximal efficacy was expected. Original study was initiated with only 2 doses, therefore, lower 70mg arm was added to this study, changing randomization ratio from 1:1:1 to 2:1:2:2 to either placebo, bimagrumab 70mg, 210mg, or 700mg. Since 70mg dose was expected to show suboptimal efficacy, fewer patients were randomized to this group & it was used only for dose response modelling & not hypothesis testing. Consequently, no efficacy evaluation for 70mg were performed
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Timepoint [2]
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Week 24
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Secondary outcome [3]
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Incidence of Falls up to Week 48
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Assessment method [3]
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Group falls rate
The frequency of having at least one fall up to Week 48 was summarized by treatment groups
Incidence of falls was calculated for each arm up to Week 48. The ratio of these fall rates versus Placebo were calculated and presented as the Falls Rate Ratio. As mentioned in comment 5.1 above, the Falls Rate Ratio for Placebo does not apply because it would entail comparing the group to itself
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Timepoint [3]
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Up to Week 48
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Eligibility
Key inclusion criteria
Must have X-ray confirmed successful hip fracture repair; Must have completed surgical
wound healing; Ability to walk a specified distance with or without a walking aid; Must
weigh at least 35 kg.
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Minimum age
60
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Must not have history of any other lower limb fractures in the past 6 months; Must not have
certain cardiovascular conditions; Must not have a chronic active infection (e.g. HIV,
hepatitis B or C, etc); Must not have used high-dose corticosteroid medications for at
least 3 months in the past year;
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/09/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
25/10/2018
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Sample size
Target
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Accrual to date
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Final
251
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Novartis Investigative Site - Bedford Park
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Recruitment postcode(s) [1]
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5041 - Bedford Park
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Recruitment outside Australia
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Georgia
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United States of America
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Minnesota
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United States of America
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New York
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Argentina
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Ciudad Autonoma de Bs As
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Austria
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Graz
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Belgium
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Brugge
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Belgium
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Genk
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Belgium
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Gent
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Chile
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Santiago
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Colombia
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Valle Del Cauca
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Colombia
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Barranquilla
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Czech Republic
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Czechia
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Praha 10
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France
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Lille Cedex
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France
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Montpellier
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Germany
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Bad Abbach
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Germany
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Dresden
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Germany
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Germany
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Würzburg
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Hungary
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Budapest
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Hungary
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Hatvan
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Hyogo
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Japan
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Kanagawa
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Japan
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Kochi
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Japan
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Kumamoto
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Japan
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Okayama
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Japan
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Toyama
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Mexico
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Aguascalientes
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Mexico
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San Luis Potosi
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Sestroretsk
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Russian Federation
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St.- Petersburg
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Russian Federation
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Yaroslavl
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Spain
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Catalunya
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Spain
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Madrid
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Switzerland
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Genève 14
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Kaohsiung
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Taoyuan
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Istanbul
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Izmir
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United Kingdom
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Bath
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study was to assess if bimagrumab is safe and effective in patients with
muscle wasting (atrophy) after hip fracture surgery.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02152761
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02152761
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