Study To Assess Fracture Healing With Sclerostin Antibody
This study has been completed.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01081678
First received: March 4, 2010
Last updated: January 15, 2014
Last verified: January 2014
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| 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) |
| Genders Eligible for Study: | Both |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01081678
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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:
| 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 |
| Health Authority: | Belgium: Federal Agency for Medicines and Health Products, FAMHP Bulgaria: Bulgarian Drug Agency Canada: Health Canada Denmark: Danish Medicines Agency Estonia: State Agency of Medicines Finland: Finnish Medicines Agency (FIMEA) Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe Greece: National Organization for Medicines Hong Kong: Department of Health Hungary: National Institute of Pharmacy India: Central Drugs Standard Control Organization Italy: COMITATO ETICO DELL´ENTE OSPEDALIERO OSPEDALI GALLIERA DI GENOVA Latvia: State Agency of Medicines Lithuania: State Medicines Control Agency of Lithuania Netherlands:Centrale Commissie Mensgebonden Onderzoek (CCMO) New Zealand: Medicines and Medical Devices Safety Authority Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Slovenia: Agency for Medicinal Products and Medicinal Devices of the Republic of Slovenia (ARSZMP) Sweden: Medical Products Agency Switzerland: Swissmedic (Swiss Agency for Therapeutic Products) United Kingdom: Medicines and Healthcare Products Regulatory Agency Argentina: ANMAT (Administracion Nacional de Medicamentos Alimentos y Tecnologia Medica) Australia: Department of Health and Ageing Therapeutic Goods Administration United States: Food and Drug Administration |
Keywords provided by Amgen:
|
AMG 785 Proximal Femur Fracture Healing Hip Fracture |
Additional relevant MeSH terms:
|
Fractures, Bone Hip Fractures Wounds and Injuries |
Femoral Fractures Hip Injuries Leg Injuries |
ClinicalTrials.gov processed this record on September 29, 2016