Study of AMG 785 in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing
Tracking InformationStart Date ICMJE | July 2009 |
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Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) |
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Current Primary Outcome Measures ICMJE (submitted: May 21, 2009) | Time to radiographic healing for the AMG 785 and placebo groups [ Time Frame: 52 weeks ] [ Designated as safety issue: No ] |
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Original Primary Outcome Measures ICMJE | Same as current |
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Change History | Complete list of historical versions of study NCT00907296 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE (submitted: May 21, 2009) | - Physical functioning as measured by change from baseline in the SF-36 PF [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Subject incidence of revision surgery [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Time to clinical healing as determined by the ability to bear weight on the fractured limb and the absence of pain at the fracture site [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Adverse events, vital signs, laboratory data, ECG parameters, formation of anti-AMG 785 antibodies, change in lumbar spine bone mineral density, long-term effect on radiographic healing and callus size and quality [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]
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Original Secondary Outcome Measures ICMJE | Same as current |
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Descriptive InformationBrief Title ICMJE | Study of AMG 785 in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing |
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Official Title ICMJE | A Multi-center, Randomized, Double Blind, Placebo-controlled Study of AMG 785 in Skeletally Mature Adults With a Fresh Unilateral Tibial Diaphyseal Fracture Status Post Definitive Fracture Fixation With an Intramedullary Nail |
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Brief Summary | This is an international, multi-center, randomized, double blind, placebo controlled study of AMG 785 in skeletally mature adults with a fresh unilateral tibial diaphyseal fracture status post a definitive fracture fixation with an intramedullary (IM) nail. The primary hypothesis for this study is that AMG 785 compared with placebo is effective in reducing radiographic healing time of fresh tibial diaphyseal fractures. |
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Detailed Description | |
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Study Phase | Phase II |
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Study Type ICMJE | Interventional |
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Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
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Condition ICMJE | Fracture Healing |
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Intervention ICMJE | - Drug: AMG 785 70mg
70mg AMG 785, subcutaneous (under the skin) injection - Drug: AMG 785 210mg
210mg AMG 785, subcutaneous (under the skin) injection - Drug: AMG 785 140 mg
140mg AMG 785, subcutaneous (under the skin) injection - Drug: Placebo
Placebo, subcutaneous (under the skin) injection
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Study Arms / Comparison Groups | - AMG 785 dose group 5: Experimental
Three doses of 140mg AMG 785 Intervention: Drug: AMG 785 140 mg - AMG 785 dose group 3: Experimental
Two doses of 70mg AMG 785 Intervention: Drug: AMG 785 70mg - AMG 785 dose group 6: Experimental
Two doses of 140mg AMG 785 Intervention: Drug: AMG 785 140 mg - AMG 785 dose group 8: Experimental
Three doses of 210mg AMG 785 Intervention: Drug: AMG 785 210mg - AMG 785 dose group 7: Experimental
Four doses of 210mg AMG 785 Intervention: Drug: AMG 785 210mg - AMG 785 dose group 1: Experimental
Four doses of 70mg AMG 785 Intervention: Drug: AMG 785 70mg - AMG 785 dose group 2: Experimental
Three doses of 70mg AMG 785 Intervention: Drug: AMG 785 70mg - AMG 785 dose group 4: Experimental
Four doses of 140mg AMG 785 Intervention: Drug: AMG 785 140 mg - AMG 785 dose group 9: Experimental
Two doses of 210mg AMG 785 Intervention: Drug: AMG 785 210mg - Placebo arm: Placebo Comparator
Four doses of placebo Intervention: Drug: Placebo
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Recruitment InformationEstimated Enrollment ICMJE | 400 |
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Estimated Completion Date | November 2012 |
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Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) |
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Eligibility Criteria ICMJE | Inclusion Criteria: - Skeletally mature adults, age 18 to 85 years with radiographically closed growth plates
- Fresh unilateral closed or Gustilo type I or type II open tibial fracture
- Definitive fracture fixation with reamed (closed and open fractures) or unreamed (open fractures only) intramedullary nailing
Exclusion Criteria: - Major polytrauma or significant axial trauma
- Associated lower extremity fracture that will delay subject's ability to bear weight beyond the normal time expected for a tibial shaft fracture
- Use of bone grafts at the time of fracture fixation
- Pathological fracture or metabolic or bone disease
- History of spinal stenosis or facial nerve paralysis
- 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
- Subject refuses to use appropriate methods of contraception
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Gender | Both |
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Ages | 18 Years to 85 Years |
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Accepts Healthy Volunteers | No |
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Contacts ICMJE | Contact: Amgen Call Center | 866-572-6436 | | |
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Location Countries ICMJE | United States, Australia, Canada, Denmark, France, Greece, Italy, Latvia, New Zealand, Poland, Russian Federation, United Kingdom |
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Administrative InformationNCT ID ICMJE | NCT00907296 |
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Responsible Party | Global Development Leader, Amgen Inc. |
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Study ID Numbers ICMJE | 20062017 |
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Study Sponsor ICMJE | Amgen |
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Collaborators ICMJE | |
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Investigators ICMJE | |
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Information Provided By | Amgen |
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