Study To Assess Fracture Healing With Sclerostin Antibody



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:June 2010
End Date:December 2013
Contact:Amgen Call Center
Phone:866-572-6436

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A 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


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.


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
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