BYM338D2201 A Possible Treatment for Muscle Wasting after Hip Fracture
Research type
Research Study
Full title
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
IRAS ID
152857
Contact name
Jane Watson
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2013-003439-31
Research summary
Muscle loss (atrophy) is commonly seen in elderly people at risk of a hip fracture. When these people undergo surgery to fix their fracture further muscle loss can be expected because of immobility and delayed rehabilitation. This can vary depending on age, gender, and the presence of other conditions.
Approximately one third of patients with hip fracture are readmitted to the hospital within the first 6 months (Bockvaar et al 2003), a considerable portion due to infections (21%), blood clots complications (3%) and injurious falls/fractures (8%). This highlights the need for effective treatment to speed up mobility.
Antibodies are normally made by your body’s immune system to fight infections. In recent years, a number of antibodies have been designed to work as drugs. Bimagrumab is a human antibody designed to attach to a receptor in muscle. This will stop a molecule which interferes with normal muscle growth. If this molecule is blocked by bimagrumab, muscle cells can increase in size. Since people who undergo hip surgery lose muscle, treatment with bimagrumab could slow or stop this. Treatment with bimagrumab might increase muscle mass and might improve a person’s strength.
This is a multicentre study where neither patients nor doctors know what treatment a patient is receiving so results are objective. Patients included in the study must have undergone hip fracture surgery. Around 210 men and women (aged 65 years old or above) from across the world, will be added into one of 3 possible study arms (bimagrumab 10 mg/kg, 3 mg/kg or placebo as an intravenous infusion every 4 weeks). Each subject will enter a screening period between 7-28 days, after a hip surgery, followed by a 52 week treatment period.
This study is being conducted by Novartis Pharma AG.REC name
London - Surrey Borders Research Ethics Committee
REC reference
14/LO/1064
Date of REC Opinion
7 Aug 2014
REC opinion
Further Information Favourable Opinion