A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy, Safety, and Tolerability of AMG 785 in Adults with Fresh Unilateral Hip Fracture, Status Post Surgical Fixatio

Phase 2

Completed

Conditions: Fractuurgenezing
bone growth stimulation
Fracture healing

Registration Number: NL-OMON36359

Lead Sponsor: Amgen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

-Adult women or men, age >= 55 to <= 95 years at randomization
-Fresh unilateral low energy intertrochanteric or femoral neck fractures 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 fractures
-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
•ntertrochanteric fracture: sliding hip screw or intermedullary nail
•femoral neck fracture: sliding hip screw or at least three cancellous screws
-Pre- and postoperative care performed as defined in Appendix J in the protocol
-Subject or subject's legally acceptable representative has provided informed consent

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 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 asymtomatic 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
-hypocalcemia or hypercalcemia, outside of 1.1 x the normal range set by the local laboratory
-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)
-BMP-2 or BMP-7 at the time of definitive fracture fixation
-Subjects to be enrolled in DXA sub-study may not have had previous
instrumentation with implants (ie, nails, screws, pins, plates) to either hip or lower
spine
-Subject has known sensitivity to any of the products to be administered
(calcium supplements, vitamin D products, or mammalian cell derived
products)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To investigate the effect of AMG 785 compared to placebo on functional healing<br /><br>as<br /><br>measured by the timed-up-and-go test (TUG) over Weeks 6 through 20 in subjects<br /><br>with<br /><br>fresh unilateral low energetic hip (intertrochanteric or femoral neck) fracture<br /><br>(refer to<br /><br>Appendix F for description of TUG procedure).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To investigate the effect of AMG 785 compared to placebo on:<br /><br>• TUG by visit<br /><br>• Time to radiographic healing<br /><br>• Harris Hip Score<br /><br>• Pain as a result of the hip fracture as assessed by the Visual Analog Scale<br /><br>(VAS)</p><br>