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Healthcare of the Older Person clinical trial

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

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 728
days, after a hip surgery, followed by a 52 week treatment period.
This study is being conducted by Novartis Pharma AG.

Inclusion criteria:
Patients eligible for inclusion in this study have to fulfill all of the following criteria:
1. Written informed consent must be obtained before any assessment is performed;
2. Males and postmenopausal
females ≥ 65 years (as defined in Section 6.5.9);
3. Patient must have had successful surgical treatment of the hip fracture (medial, lateral and pertrochanteric proximal
femoral fracture, AO Classification 31 AC
(AO Foundation 2013);
4. Patient must be mentally competent at screening, to have scored at least ≥ 21 on the Folstein Mini Mental State
Examination (MMSE);
5. Patient must be able to complete a 4 m gait speed test at screening, between days 728
after fracture surgery;
6. Patient must be able to understand and follow the requirements and procedures for the study, be committed to
participate in rehabilitation training as outlined in Section 5.1.2 and be willing to participate for approximately 56 weeks;
7. Patients must weigh at least 35 kg and must have a body mass index (BMI) within the range of 16 – 35 kg/m2 at
screening;
8. Two to four weeks after surgery (prior to randomization): Successful surgical
intervention for fracture repair defined as 1) implantation according to manufacturer’s instructions AND 2) completed
surgical wound healing.

Exclusion criteria:
Must
not have a chronic active infection (e.g., HIV, hepatitis B or C, tuberculosis, etc);
Orthopedic history:
• History of repeated hip fracture, subtrochanteric
fractures,or any other lower limb fracture in the 6 months prior to
screening
Conditions countering muscle increase or causing muscle wasting:
• History or ongoing disease known to cause malabsorption of protein
Conditions interfering with muscle function assessments:
• severe Vitamin D deficiency (25OHvitamin
D < 9.2 ng/mL or < 23 nmol/L) Cardiovascular conditions (SAFETY): • History of ischemic heart disease or congestive heart failure (NYHA Class III/IV), or systolic blood pressure >180 or
<90 mm Hg or diastolic blood pressure >100 or <50 mmHg at screening. Hepatic enzyme elevations (SAFETY): • Abnormal liver function tests such as SGOT (AST), SGPT (ALT),alkaline phosphatase, or serum bilirubin (except Gilbert’s Disease). Other major medical conditions: • Uncontrolled diabetes mellitus (i.e. HbA1C ≥ 7.5% or average blood glucose ≥ 9.0 mmol/l) • chronic kidney disease • confirmed diagnosis of significant psyhicatric disease (dementia, Alzheimer's disease, schizophrenia or bipolar disorder) • uncontrolled hypothyroidism or hyperthyroidism. • Underlying muscle diseases, including history of or currently active form of inflammatory myopathies (e.g. dermatomyositis, polymyositis, etc) or muscular dystrophies other than agerelated sarcopenia or disuse atrophy Prohibited medications interfering with muscle metabolism/strength: • Use of any of the following therapies in the past 3 months prior to screening, including: • androgens, androgen supplements, including overthecounter dehydroepiandrosterone • progestins with known androgenic component [e.g.norethindrone acetate, megestrol acetate, highdose tibolone (2.5 mg)] • recombinant human growth hormone or growth hormone receptor antagonist (e.g., pregvisomant) Principal Investigator for this trial: Professor Opinder Sahota

Research Ethics Committee Reference: 14/LO/1064

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076

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