Study To Assess Fracture Healing With Sclerostin Antibody

• Mean value for timed-up-and-go test by visit [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
• Time to radiographic healing [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
• Mean Harris Hip Score by visit [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
• Mean pain score as measured by the visual analog scale by visit [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
• Radiographic Union Scale for Hip score by visit [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

• Mean value for timed-up-and-go test by visit [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
• Time to radiographic healing [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
• Mean Harris Hip Score by visit [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
• Mean pain score as measured by the visual analog scale by visit [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
• Adverse events, vital signs, laboratory data, ECG parameters, formation of anti-AMG 785 antibodies [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]

This is an international, multi-center, randomized, double-blind, placebo-controlled study to determine the efficacy, safety, and tolerability of AMG 785 in adults with a fresh unilateral hip fracture, status post surgical fixation.

The primary hypothesis of this study is that AMG 785 compared with placebo is effective in accelerating healing of hip fractures and improving physical functioning, as measured by the TUG, for subjects with fresh unilateral low energy hip fractures, status post surgical fixation.

• Drug: Placebo
  Placebo, subcutaneous (under the skin) injection
• Drug: AMG 785 140 mg
  140mg AMG 785, subcutaneous (under the skin) injection
• Drug: AMG785 70mg
  AMG 785 70mg, subcutaneous (under the skin) injection
• Drug: AMG 785 210mg
  210mg AMG 785, subcutaneous (under the skin) injection

• Experimental: AMG 785 dose group 2
  Four doses of 140mg AMG 785
  Intervention: Drug: AMG 785 140 mg
• Experimental: AMG 785 dose group 3
  Four doses of 210mg AMG 785
  Intervention: Drug: AMG 785 210mg
• Experimental: AMG 785 dose group 1
  Four doses of 70mg AMG 785
  Intervention: Drug: AMG785 70mg
• Placebo Comparator: Placebo arm
  Four doses of placebo
  Intervention: Drug: Placebo

Inclusion Criteria:

• Males and females, age 55 to 95 years
• Fresh unilateral low energy intertrochanteric or femoral neck fracture as the primary injury
• Intertrochanteric fractures eligible for this study must have at least two displaced fragments
• Internal fixation of the intertrochanteric fracture with sliding hip screw or intramedullary nail
• Internal fixation of femoral neck fracture with either a sliding hip screw or at least three cancellous screws

Exclusion Criteria:

• Major polytrauma or significant axial trauma
• 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
• Inability to independently rise from armchair or walk 200 meters before hip fracture (use of unilateral assistive device or rolling walker is acceptable)
• Severe symptomatic osteoarthritis of the lower extremity
• Cognitive deficit or symptomatic neurological conditions such as Parkinson's disease or persistent gross motor or sensory deficits such as hemiparesis or hemiplegia
• Use of bone grafts at the time of fracture fixation
• Pathological fracture or metabolic or bone disease
• History of facial nerve paralysis or symptomatic spinal stenosis that has not been surgically corrected. If surgically corrected, the subject must be asymptomatic to be eligible for the study
• Malignancy within the last 5 years
• Evidence of the following (currently or within the past 5 years): elevated transaminases, significantly impaired renal function, current hyper- or hypocalcaemia, hypoalbuminemia
• Use of agents affecting bone metabolism