Study To Assess Fracture Healing With Sclerostin Antibody - Full Text View

Purpose

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	Intervention	Phase
Fracture Healing	Drug: Placebo Drug: AMG 785 140 mg Drug: AMG785 70mg Drug: AMG 785 210mg	Phase 2


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Fractures Hip Injuries and Disorders

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

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:

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


Enrollment:	332
Study Start Date:	June 2010
Study Completion Date:	January 2013
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081678

Show 99 Study Locations

Sponsors and Collaborators

Amgen

Investigators


Study Director:	MD	Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site


Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT01081678 History of Changes
Other Study ID Numbers:	20080394
Study First Received:	March 4, 2010
Last Updated:	January 15, 2014

Keywords provided by Amgen:


AMG 785 Proximal Femur Fracture Healing Hip Fracture

Additional relevant MeSH terms:


Fractures, Bone Wounds and Injuries

ClinicalTrials.gov processed this record on August 18, 2017