Study To Assess Fracture Healing With Sclerostin Antibody
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ClinicalTrials.gov Identifier: NCT01081678 |
Recruitment Status
:
Completed
First Posted
: March 5, 2010
Last Update Posted
: February 12, 2014
|
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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 |
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
|
- 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 ]
- 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 ]

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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

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 ClinicalTrials.gov identifier (NCT number): NCT01081678

Study Director: | MD | Amgen |
Additional Information:
Responsible Party: | Amgen |
ClinicalTrials.gov 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 |