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
  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
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
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 ClinicalTrials.gov identifier: NCT01081678

  Hide Study Locations
Locations
United States, Alabama
Research Site
Birmingham, Alabama, United States, 35294
United States, California
Research Site
Pomona, California, United States, 91767
United States, Colorado
Research Site
Aurora, Colorado, United States, 80012
Research Site
Denver, Colorado, United States, 80204
United States, Indiana
Research Site
Indianapolis, Indiana, United States, 46202
United States, Minnesota
Research Site
Woodbury, Minnesota, United States, 55125
United States, Missouri
Research Site
St. Louis, Missouri, United States, 63110
United States, New York
Research Site
Brooklyn, New York, United States, 11220
Research Site
Rochester, New York, United States, 14642
United States, Pennsylvania
Research Site
Altoona, Pennsylvania, United States, 16602
Research Site
Philadelphia, Pennsylvania, United States, 19104
Research Site
State College, Pennsylvania, United States, 16801
Argentina
Research Site
Buenos Aires, Argentina, C1012AAR
Research Site
Buenos Aires, Argentina, C1419AHN
Australia, New South Wales
Research Site
Liverpool, New South Wales, Australia, 2170
Australia, Victoria
Research Site
Footscray, Victoria, Australia, 3011
Belgium
Research Site
Brugge, Belgium, 8000
Research Site
Genk, Belgium, 3600
Research Site
Leuven, Belgium, 3000
Research Site
Liege, Belgium, 4000
Research Site
Liège, Belgium, 4020
Bulgaria
Research Site
Blagoevgrad, Bulgaria, 2700
Research Site
Pleven, Bulgaria, 5800
Research Site
Plovdiv, Bulgaria, 4002
Canada, Alberta
Research Site
Red Deer, Alberta, Canada, T4N 6V7
Canada, Ontario
Research Site
Cambridge, Ontario, Canada, N1R 3G2
Research Site
Guelph, Ontario, Canada, N1E 4J4
Research Site
Ottawa, Ontario, Canada, K1Y 4E9
Research Site
Toronto, Ontario, Canada, M5C 1R6
Research Site
Waterloo, Ontario, Canada, N2J 1C4
Canada, Quebec
Research Site
Montreal, Quebec, Canada, H4J 1C5
Canada
Research Site
Quebec, Canada, G1J 1Z4
Research Site
Quebec, Canada, G1R 2J6
Denmark
Research Site
Hvidovre, Denmark, 2650
Research Site
København NV, Denmark, 2400
Research Site
Viborg, Denmark, 8800
Research Site
Ã…rhus C, Denmark, 8000
Estonia
Research Site
Tallinn, Estonia, 11312
Research Site
Tartu, Estonia, 50410
Finland
Research Site
Kuopio, Finland, 70211
Research Site
Oulu, Finland, 90220
Research Site
Turku, Finland, 20520
Germany
Research Site
Aachen, Germany, 52074
Research Site
Berlin, Germany, 12200
Research Site
Muenchen, Germany, 80336
Research Site
Muenster, Germany, 48149
Greece
Research Site
Athens, Greece, 14561
Research Site
Athens, Greece, 12462
Research Site
Larissa, Greece, 41110
Research Site
Patra, Greece, 26500
Research Site
Thessaloniki, Greece, 56429
Hong Kong
Research Site
Hong Kong, Hong Kong
Research Site
New Territories, Hong Kong
Hungary
Research Site
Budapest, Hungary, 1081
Research Site
Miskolc, Hungary, 3526
Research Site
Nyiregyhaza, Hungary, 4400
Research Site
Szeged, Hungary, 6725
India
Research Site
Hyderabad, Andhra Pradesh, India, 500 063
Research Site
Bangalore, Karnataka, India, 560 054
Research Site
Mangalore, Karnataka, India, 575 002
Research Site
Nashik, Maharashtra, India, 422 002
Research Site
Pune, Maharashtra, India, 411 044
Research Site
Pune, Maharashtra, India, 411 005
Research Site
Jaipur, Rajasthan, India, 302 022
Research Site
Mangalore, India, 575 001
Research Site
Nashik, India, 422 009
Italy
Research Site
Firenze, Italy, 50139
Research Site
Milano, Italy, 20142
Research Site
Roma (RM), Italy, 00133
Research Site
Verona, Italy, 37126
Latvia
Research Site
Riga, Latvia, 1005
Research Site
Valmiera, Latvia, 4201
Lithuania
Research Site
Kaunas, Lithuania, 44320
Research Site
Vilnius, Lithuania, 04130
Netherlands
Research Site
Amsterdam, Netherlands, 1061 AE
Research Site
Amsterdam, Netherlands, 1105 AZ
Research Site
Amsterdam, Netherlands, 1091 AC
Research Site
Haarlem, Netherlands, 2035 RC
Research Site
Nieuwegein, Netherlands, 3435 CM
New Zealand
Research Site
Christchurch, New Zealand, 8022
Poland
Research Site
Kraków, Poland, 31-826
Research Site
Lublin, Poland, 20-718
Research Site
Warszawa, Poland, 00-739
Research Site
Warszawa, Poland, 03-242
Slovenia
Research Site
Celje, Slovenia, 3000
Research Site
Izola, Slovenia, 6310
Research Site
Jesenice, Slovenia, 4270
Research Site
Sempeter pri Gorici, Slovenia, 5290
Sweden
Research Site
Linköping, Sweden, 581 85
Research Site
Lund, Sweden, 221 85
Switzerland
Research Site
Basel, Switzerland, 4031
Research Site
Lausanne, Switzerland, 1011
Research Site
Luzern, Switzerland, 6000
Research Site
Zurich, Switzerland, 8063
United Kingdom
Research Site
Barnet, United Kingdom, EN5 3DJ
Research Site
Leeds, United Kingdom, LS1 3EX
Research Site
London, United Kingdom, E1 1BB
Research Site
Newcastle, United Kingdom, NE1 4LP
Research Site
Norwich, United Kingdom, NR4 7UY
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

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
Wounds and Injuries

ClinicalTrials.gov processed this record on October 29, 2014