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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2013-003439-31
Secondary ID [2] 0 0
CBYM338D2201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle Wasting (Atrophy) After Hip Fracture Surgery 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Injuries and Accidents 0 0 0 0
Fractures

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Total Lean Body Mass Measured by DXA (Dual-energy X-ray Absorptiometry) at Weeks 12 and 24
Assessment method [1] 0 0
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
Timepoint [1] 0 0
baseline, weeks 12 and 24
Secondary outcome [1] 0 0
Change From Baseline in Gait Speed at Week 24 (Meters/Sec)
Assessment method [1] 0 0
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
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [2] 0 0
Change From Baseline in Short Physical Performance Battery at Weeks 24
Assessment method [2] 0 0
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
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Incidence of Falls up to Week 48
Assessment method [3] 0 0
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
Timepoint [3] 0 0
Up to Week 48

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.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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;

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/10/2018
Sample size
Target
Accrual to date
Final
251
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Bedford Park
Recruitment postcode(s) [1] 0 0
5041 - Bedford Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
Argentina
State/province [7] 0 0
Ciudad Autonoma de Bs As
Country [8] 0 0
Austria
State/province [8] 0 0
Graz
Country [9] 0 0
Belgium
State/province [9] 0 0
Brugge
Country [10] 0 0
Belgium
State/province [10] 0 0
Genk
Country [11] 0 0
Belgium
State/province [11] 0 0
Gent
Country [12] 0 0
Chile
State/province [12] 0 0
Santiago
Country [13] 0 0
Colombia
State/province [13] 0 0
Valle Del Cauca
Country [14] 0 0
Colombia
State/province [14] 0 0
Barranquilla
Country [15] 0 0
Czechia
State/province [15] 0 0
Czech Republic
Country [16] 0 0
Czechia
State/province [16] 0 0
Praha 10
Country [17] 0 0
France
State/province [17] 0 0
Lille Cedex
Country [18] 0 0
France
State/province [18] 0 0
Montpellier
Country [19] 0 0
Germany
State/province [19] 0 0
Bad Abbach
Country [20] 0 0
Germany
State/province [20] 0 0
Dresden
Country [21] 0 0
Germany
State/province [21] 0 0
Magdeburg
Country [22] 0 0
Germany
State/province [22] 0 0
Würzburg
Country [23] 0 0
Hungary
State/province [23] 0 0
Budapest
Country [24] 0 0
Hungary
State/province [24] 0 0
Hatvan
Country [25] 0 0
Japan
State/province [25] 0 0
Hyogo
Country [26] 0 0
Japan
State/province [26] 0 0
Kanagawa
Country [27] 0 0
Japan
State/province [27] 0 0
Kochi
Country [28] 0 0
Japan
State/province [28] 0 0
Kumamoto
Country [29] 0 0
Japan
State/province [29] 0 0
Okayama
Country [30] 0 0
Japan
State/province [30] 0 0
Toyama
Country [31] 0 0
Mexico
State/province [31] 0 0
Aguascalientes
Country [32] 0 0
Mexico
State/province [32] 0 0
San Luis Potosi
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Saint-Petersburg
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Sestroretsk
Country [35] 0 0
Russian Federation
State/province [35] 0 0
St.- Petersburg
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Yaroslavl
Country [37] 0 0
Spain
State/province [37] 0 0
Andalucia
Country [38] 0 0
Spain
State/province [38] 0 0
Catalunya
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Switzerland
State/province [40] 0 0
Genève 14
Country [41] 0 0
Taiwan
State/province [41] 0 0
Kaohsiung
Country [42] 0 0
Taiwan
State/province [42] 0 0
Taipei
Country [43] 0 0
Taiwan
State/province [43] 0 0
Taoyuan
Country [44] 0 0
Turkey
State/province [44] 0 0
Istanbul
Country [45] 0 0
Turkey
State/province [45] 0 0
Izmir
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Bath

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02152761