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Study To Assess Fracture Healing With Sclerostin Antibody

This study has been completed.
Information provided by (Responsible Party):
Amgen Identifier:
First received: March 4, 2010
Last updated: January 15, 2014
Last verified: January 2014

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: Double Blind (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:

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


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

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 identifier: NCT01081678

  Show 99 Study Locations
Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen 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 processed this record on April 21, 2017