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

  Show 99 Study Locations
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 22, 2014