Study To Assess Fracture Healing With Sclerostin Antibody

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01081678
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : February 12, 2014
Information provided by (Responsible Party):

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 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

Resource links provided by the National Library of Medicine

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

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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   55 Years to 95 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01081678

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

Additional Information:
Responsible Party: Amgen Identifier: NCT01081678     History of Changes
Other Study ID Numbers: 20080394
First Posted: March 5, 2010    Key Record Dates
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