Study of AMG785 in hip fracture

Conditions: Acceleration of fracture healing
MedDRA version: 14.1Level: PTClassification code 10016454Term: Femur fractureSystem Organ Class: 10022117 - Injury, poisoning and procedural complications
Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

Registration Number: EUCTR2009-015939-33-NL

Lead Sponsor: Amgen Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 330

Inclusion Criteria

Adult women or men, age = 55 to = 95 years at randomization

Fresh unilateral low energy intertrochanteric or femoral neck fracture as the primary injury, confirmed by X-ray and in the opinion of the treating surgeon amenable to repair by internal fixation

Intertrochanteric fractures eligible for this study must have at least two displaced fragments

Internal fixation of the fracture with devices approved by local regulatory agency, performed no later than 7 days after injury for intertrochanteric or undisplaced femoral neck fractures and no later than 2 days after injury for displaced femoral neck fractures
• Intertrochanteric fracture: sliding hip screw or IM nail
• Femoral neck fracture: sliding hip screw or at least three cancellous screws

Pre- and postoperative care performed as defined in Appendix I

Subject or subject’s legally acceptable representative has provided informed
consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

Conditions that may affect the ability to perform functional or clinical
assessments required by the protocol, such as:

• Severe symptomatic osteoarthritis of the lower extremity
• Inability to independently rise from armchair or walk 200 meters before hip
fracture (use of unilateral assistive device or rolling walker is acceptable)
• Cognitive deficit, as defined by Mini-Mental Status Examination score < 22 at
time of randomization
• Symptomatic neurological conditions such as Parkinson’s disease or persistent
gross motor or sensory deficits such as hemiparesis or hemiplegia
• Presence of concomitant injuries such as rib fractures, wrist fractures, or acute
symptomatic vertebral fractures which severely impair the ability to rise from a
chair
• Associated extremity injuries including ipsilateral or contralateral fractures of the
foot, tibia or fibula, wrist, humerus, femoral shaft, femoral head or hip dislocation,
that may delay weight-bearing beyond one week after surgery

Use of bone grafts or bone substitutes at the time of fracture fixation

Head-injury, as defined by Glasgow Coma Scale <13 prior to randomization

Major polytrauma or significant axial trauma, with Injury Severity Score > 16

Pathological fracture or history of metabolic or bone disease (except
osteoporosis) that may interfere with the interpretation of the results, such as Paget’s disease, rheumatoid
arthritis, osteomalacia, osteopetrosis, ankylosing spondylitis, Cushing’s disease,
hyperprolactinemia

History of symptomatic spinal stenosis that has not been surgically corrected. If surgically corrected, the subject must be asymptomatic to be eligible for the study

History of facial nerve paralysis

Malignancy (except fully resected cutaneous basal cell or squamous cell
carcinoma, cervical carcinoma in situ) within the last 5 years

Severe asthma or severe chronic obstructive pulmonary disease or recent exacerbation

Myocardial infarction or unstable angina pectoris within the last 12 months

Current alcohol dependence

History of solid organ or bone marrow transplants

Per subject report, chart review or local laboratory result, evidence of currently abnormal values for the following:
• Elevated transaminases (a) Serum aspartate aminotransferase = 2.0 x
upper limits of normal; (b) Serum alanine aminotransferase = 2.0 x upper
limits of normal
• Significantly impaired renal function as determined by a derived creatinine
clearance of = 30 mL/min using the Modification of Diet in Renal Disease
equation (Levey et al, 1999). The estimated glomerular filtration rate is
calculated as follows: estimated glomerular filtration rate (mL/min/1.73m2)
= 186 x [Serum creatinine (mg/dL)]-1.154 x [Age]-0.203 x [0.742 if subject is
female] x [1.210 if subject is black].
• Hypocalcemia or hypercalcemia, outside of 1.1 x the normal range set by the local laboratory

Known to have tested positive for human immunodeficiency virus, hepatitis C
virus, or hepatitis B surface antigen

- Use of the following agents affecting bone metabolism
• Within the past 12 months: parathyroid hormone, strontium, fluoride (for osteoporosis)
• Within the past 6 months: IV bisphosphonates, denosumab, odanacatib (MK-0822)
• Within the past 3 months: calcitonin, tibolone, cinacalcet, systemic glucocorticosteroids (= 5 mg prednisone equivalent per day for more than 10 days)

Bone Morphogenetic Protein (BMP)-2 or BMP-7 at the time of definitive f