Study To Assess Fracture Healing With Sclerostin Antibody

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01081678
First received: March 4, 2010
Last updated: January 15, 2014
Last verified: January 2014

March 4, 2010
January 15, 2014
June 2010
October 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01081678 on ClinicalTrials.gov Archive Site
  • Mean value for timed-up-and-go test by visit [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Time to radiographic healing [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Mean Harris Hip Score by visit [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Mean pain score as measured by the visual analog scale by visit [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Radiographic Union Scale for Hip score by visit [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Mean value for timed-up-and-go test by visit [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Time to radiographic healing [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Mean Harris Hip Score by visit [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Mean pain score as measured by the visual analog scale by visit [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Adverse events, vital signs, laboratory data, ECG parameters, formation of anti-AMG 785 antibodies [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study To Assess Fracture Healing With Sclerostin Antibody
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fracture Healing
  • Drug: Placebo
    Placebo, subcutaneous (under the skin) injection
  • Drug: AMG 785 140 mg
    140mg AMG 785, subcutaneous (under the skin) injection
  • Drug: AMG785 70mg
    AMG 785 70mg, subcutaneous (under the skin) injection
  • Drug: AMG 785 210mg
    210mg AMG 785, subcutaneous (under the skin) injection
  • Experimental: AMG 785 dose group 2
    Four doses of 140mg AMG 785
    Intervention: Drug: AMG 785 140 mg
  • Experimental: AMG 785 dose group 3
    Four doses of 210mg AMG 785
    Intervention: Drug: AMG 785 210mg
  • Experimental: AMG 785 dose group 1
    Four doses of 70mg AMG 785
    Intervention: Drug: AMG785 70mg
  • Placebo Comparator: Placebo arm
    Four doses of placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
332
January 2013
October 2012   (final data collection date for primary outcome measure)

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
Both
55 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Bulgaria,   Canada,   Denmark,   Estonia,   Finland,   Germany,   Greece,   Hong Kong,   Hungary,   India,   Italy,   Latvia,   Lithuania,   Netherlands,   New Zealand,   Poland,   Slovenia,   Sweden,   Switzerland,   United Kingdom
 
NCT01081678
20080394
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP