Clinical trial NCT02152761: Study of Efficacy and Safety of Bimagrumab in Patients After Hip Fracture Surgery
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Muscle Wasting (Atrophy) After Hip Fracture Surgery
Keywords: bimagrumab
BYM338
hip fracture
elderly
controlled clinical trial
randomized
muscle wasting
atrophy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-06-02
Enrollment: 251
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, interventional, multicenter, placebo-controlled, phase IIa/IIb trial in patients
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Change From Baseline in Total Lean Body Mass Measured by DXA (Dual-energy X-ray Absorptiometry) at Weeks 12 and 24
timeFrame: baseline, weeks 12 and 24
Secondary outcomes:
measure: Change From Baseline in Gait Speed at Week 24 (Meters/Sec)
timeFrame: Baseline, Week 24
measure: Change From Baseline in Short Physical Performance Battery at Weeks 24
timeFrame: Week 24
measure: Incidence of Falls up to Week 48
timeFrame: Up to Week 48
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Novartis Investigative Site
state: Arizona
city: El Cajon
country: United States
facility: Novartis Investigative Site
state: California
city: Denver
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Gainesville
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Rochester
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Ciudad Autonoma de Bs As
country: Argentina
facility: Novartis Investigative Site
city: Bedford Park
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Brugge
country: Belgium
facility: Novartis Investigative Site
city: Genk
country: Belgium
facility: Novartis Investigative Site
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Santiago
country: Chile
facility: Novartis Investigative Site
city: Cali
country: Colombia
facility: Novartis Investigative Site
state: Valle Del Cauca
city: Barranquilla
country: Colombia
facility: Novartis Investigative Site
city: Brno
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Hradec Kralove
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Pardubice
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Plzen
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Praha 5
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Praha 10
country: Czechia
facility: Novartis Investigative Site
city: Lille Cedex
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Bad Abbach
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Würzburg
country: Germany
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Hatvan
country: Hungary
facility: Novartis Investigative Site
city: Nishinomiya-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kamakura-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kochi-city
country: Japan
facility: Novartis Investigative Site
state: Kochi
city: Kumamoto-city
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Okayama city
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Toyama-City
country: Japan
facility: Novartis Investigative Site
state: Toyama
city: Aguascalientes
country: Mexico
facility: Novartis Investigative Site
city: San Luis Potosi
country: Mexico
facility: Novartis Investigative Site
city: Saint-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Sestroretsk
country: Russian Federation
facility: Novartis Investigative Site
city: St.- Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Genève 14
country: Switzerland
facility: Novartis Investigative Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taoyuan
country: Taiwan
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Bath
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Hofbauer LC, Witvrouw R, Varga Z, Shiota N, Cremer M, Tanko LB, Rooks D, Auberson LZ, Arkuszewski M, Fretault N, Schubert-Tennigkeit AA, Papanicolaou DA, Recknor C. Bimagrumab to improve recovery after hip fracture in older adults: a multicentre, double-blind, randomised, parallel-group, placebo-controlled, phase 2a/b trial. Lancet Healthy Longev. 2021 May;2(5):e263-e274. doi: 10.1016/S2666-7568(21)00084-2.