Study of Efficacy and Safety of Bimagrumab in Patients After Hip Fracture Surgery

Novartis Pharmaceuticals251 enrolled

Overview

The purpose of this study was to assess if bimagrumab is safe and effective in patients with muscle wasting (atrophy) after hip fracture surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

251

Conditions

Muscle Wasting (Atrophy) After Hip Fracture Surgery

Interventions

bimagrumabDRUG

Bimagrumab was administered as intravenous infusion starting on Day 1 until week 20.

placeboOTHER

Matching placebo was administered as intravenous infusion starting on Day 1 until week 20.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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. 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;

Locations (53)

Outcomes

Primary Outcomes

Change From Baseline in Total Lean Body Mass Measured by DXA (Dual-energy X-ray Absorptiometry) at Weeks 12 and 24

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

Time frame: baseline, weeks 12 and 24

Secondary Outcomes

Change From Baseline in Gait Speed at Week 24 (Meters/Sec)

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

Time frame: Baseline, Week 24

Change From Baseline in Short Physical Performance Battery at Weeks 24

Data from ClinicalTrials.gov

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Novartis Investigative Site

Phoenix, Arizona, United States

Novartis Investigative Site

El Cajon, California, United States

Novartis Investigative Site

Denver, Colorado, United States

Novartis Investigative Site

Gainesville, Georgia, United States

Novartis Investigative Site

Rochester, Minnesota, United States

Novartis Investigative Site

New York, New York, United States

Novartis Investigative Site

Ciudad Autonoma de Bs As, Argentina

Novartis Investigative Site

Bedford Park, South Australia, Australia

Novartis Investigative Site

Graz, Austria

Novartis Investigative Site

Bruges, Belgium

...and 43 more locations

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