Study of efficacy and safety of Bimagrumab in patients after hip fracture surgery

A 24-week double blind treatment and 24-week follow up, randomized, multi-center, placebo-controlled, phase IIa/IIb study to evaluate the safety and efficacy of i.v. bimagrumab on total lean body mass and physical performance in patients after surgical treatment of hip fracture

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003439-31-DE

Enrollment

245

Registered

2014-06-04

Start date

2014-09-10

Completion date

Unknown

Last updated

2018-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with muscle wasting (atrophy) after hip fracture surgery and subsequent postsurgical rehabilitation MedDRA version: 20.0 Level: LLT Classification code 10028371 Term: Muscular wasting and disuse atrophy, not elsewhere classified System Organ Class: 100000004859 MedDRA version: 20.0 Level: PT Classification code 10020100 Term: Hip fracture System Organ Class: 10022117 - Injury, poisoning and procedural complications

Interventions

Product Code: BYM338 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Bimagrumab CAS Number: 1356922-05-8 Current Sponsor code: BYM338 Other descriptive name: Human Mono

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Must have had surgical fixation or arthroplasty for a fracture of the proximal femur as confirmed by radiography; Must be able to complete a 4 m gait speed test; Must have completed surgical wound healing; Must weigh at least 35 kg. Other protocol-defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 245

Exclusion criteria

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; Other protocol-defined exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess change from baseline to week 24 in total lean body mass.;Secondary Objective: To assess: - Change from baseline at week 24 in gait speed. - Change from baseline at week 24 in physical performance as measured by the Short Physical Performance Battery (SPPB) - Safety and tolerability assessed by various measures such as vital signs, clinical laboratory variables, electrocardiogram (ECG), echocardiogram (only on patients enrolled before Amendment #3), adverse events (AE), X-ray assessment of the surgical procedure and potential orthopedic complications. - The post treatment effect on physical performance and mobility as measured by SPPB and gait speed up to End of Study - effects on incidence of falls;Primary end point(s): Change from baseline to week 24 in total lean body mass;Timepoint(s) of evaluation of this end point: Baseline and Week 24	—

Measure

Time frame

Main Objective: To assess change from baseline to week 24 in total lean body mass.;Secondary Objective: To assess: - Change from baseline at week 24 in gait speed. - Change from baseline at week 24 in physical performance as measured by the Short Physical Performance Battery (SPPB) - Safety and tolerability assessed by various measures such as vital signs, clinical laboratory variables, electrocardiogram (ECG), echocardiogram (only on patients enrolled before Amendment #3), adverse events (AE), X-ray assessment of the surgical procedure and potential orthopedic complications. - The post treatment effect on physical performance and mobility as measured by SPPB and gait speed up to End of Study - effects on incidence of falls;Primary end point(s): Change from baseline to week 24 in total lean body mass;Timepoint(s) of evaluation of this end point: Baseline and Week 24

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: A & B: Baseline, week 24 C: Baseline, week 4, week 8, week 12, week 16, week 20, week 24, week 36, week 48 D: Baseline, week 24, week 36, week 48 E: Week 24 and Week 48;Secondary end point(s): A. Change from baseline to week 24 in gait speed. B. Change from baseline to week 24 in physical performance as measured by the Short Physical Performance Battery C. Safety and tolerability assessed by various measures such as adverse events D. Change from baseline to week 48 in SPPB and gait speed E. Frequency of falls	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: A & B: Baseline, week 24 C: Baseline, week 4, week 8, week 12, week 16, week 20, week 24, week 36, week 48 D: Baseline, week 24, week 36, week 48 E: Week 24 and Week 48;Secondary end point(s): A. Change from baseline to week 24 in gait speed. B. Change from baseline to week 24 in physical performance as measured by the Short Physical Performance Battery C. Safety and tolerability assessed by various measures such as adverse events D. Change from baseline to week 48 in SPPB and gait speed E. Frequency of falls

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Countries

Argentina, Australia, Austria, Belgium, Chile, Colombia, Czech Republic, France, Germany, Hungary, Japan, Mexico, Romania, Russian Federation, Spain, Switzerland, Taiwan, Turkey, United Kingdom, United States

Contacts

Public ContactMedizinischer Infoservice (MCC)

Novartis Pharma GmbH

infoservice.novartis@novartis.com+491802232300

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026