Study To Assess Fracture Healing With Sclerostin Antibody

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Fracture Healing	Drug: Placebo; Drug: AMG 785 140 mg; Drug: AMG785 70mg; Drug: AMG 785 210mg	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	332 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	June 2010
Actual Primary Completion Date :	October 2012
Actual Study Completion Date :	January 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: AMG 785 dose group 2; Four doses of 140mg AMG 785	Drug: AMG 785 140 mg; 140mg AMG 785, subcutaneous (under the skin) injection
Experimental: AMG 785 dose group 3; Four doses of 210mg AMG 785	Drug: AMG 785 210mg; 210mg AMG 785, subcutaneous (under the skin) injection
Experimental: AMG 785 dose group 1; Four doses of 70mg AMG 785	Drug: AMG785 70mg; AMG 785 70mg, subcutaneous (under the skin) injection
Placebo Comparator: Placebo arm; Four doses of placebo	Drug: Placebo; Placebo, subcutaneous (under the skin) injection

Outcome Measures

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Primary Outcome Measures :

1. Functional healing as measured by the mean value for the timed-up-and-go test over weeks 6 to 20 for the AMG 785 and placebo groups [ Time Frame: 20 weeks ]

Secondary Outcome Measures :

1. Mean value for timed-up-and-go test by visit [ Time Frame: 52 weeks ]
2. Time to radiographic healing [ Time Frame: 52 weeks ]
3. Mean Harris Hip Score by visit [ Time Frame: 52 weeks ]
4. Mean pain score as measured by the visual analog scale by visit [ Time Frame: 52 weeks ]
5. Radiographic Union Scale for Hip score by visit [ Time Frame: 52 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	55 Years to 95 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 99 Study Locations

Sponsors and Collaborators

Amgen

Investigators

Study Director:	MD	Amgen

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

AmgenTrials clinical trials website 

Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT01081678 History of Changes
Other Study ID Numbers:	20080394
First Posted:	March 5, 2010
Last Update Posted:	February 12, 2014
Last Verified:	January 2014

Keywords provided by Amgen:

AMG 785; Proximal Femur; Fracture Healing; Hip Fracture

Additional relevant MeSH terms:

Fractures, Bone; Wounds and Injuries