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 - AMG 785 20062017

Conditions: Acceleration of fracture healing
MedDRA version: 12.1Level: LLTClassification code 10043827Term: Tibia fracture

Registration Number: EUCTR2008-008392-34-IT

Lead Sponsor: Amgen Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

Skeletally mature adults, age ≥18 to ≤ 85 years at randomization, with radiographically closed growth plates Fresh unilateral closed or Gustilo type I or type II open tibial fracture as the primary injury For closed fractures: Definitive fracture fixation with reamed IM nailing (modern, statically, interlocking nail) performed no later than 14 days after injury For Gustilo type I/II open fractures: Definitive fracture fixation with reamed or unreamed IM nailing (modern, statically, interlocking nail) performed no later than 24 hours after injury
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Major polytrauma or significant axial trauma, with injury severity score >16Head-injury, as defined by Glasgow Coma Scale <13 at time of randomization Associated fracture of the lower extremity that, in the opinion of the surgeon, will delay the subjects ability to bear weight beyond the normal time expected for a tibial shaft fractureUse of bone grafts at the time of definitive fracture fixationHistory of pathological fracture or metabolic or bone disease that may interfere with the interpretation of the results, such as Pagets disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushings disease, hyperprolactinemia History of spinal stenosisHistory of facial nerve paralysisMalignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical carcinoma in situ) within the last 5 yearsHistory of solid organ or bone marrow transplantsEvidence of the following per subject report, chart review or local laboratory result (currently or within the past 5 years)oElevated transaminases (≥ 2.0 x upper limits of normal)oSignificantly impaired renal function as determined by a derived creatinine clearance of ≤ 30 mL/min using the Modification of Diet in Renal Disease equation-Current hypercalcemia or hypocalcaemia (outside of the normal range)-hypoalbuminemia (below lower limit of normal)Known to have tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigenUse of the following agents affecting bone metabolism: intravenous bisphosphonates at any time; denosumab at any time; fluoride (for osteoporosis) within the past 24 months; oral bisphosphonates, parathyroid hormone or strontium within the past 12 months; calcitonin, selective estrogen receptor Modulators, systemic oral or transdermal estrogen within the past three months (estrogen-containing contraceptive therapy is permitted); systemic glucocorticosteroids(≥5 mg prednisone equivalent per day for more than 10 days) within the past three months, or tibolone within the past three months; BMP-2 or BMP-7 at the time of definitive fracture fixation Current use of anticoagulants (doses for deep vein thrombosis prophylaxis are permitted)Currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agentsPrevious enrollment in an AMG 785 clinical study Subject of child-bearing potential who is evidently pregnant(eg, positive human chorionic gonadotropin test) or breast-feedingFemales of childbearing potential: Subject refuses to use 2 different forms of effective contraception in order to achieve a highly effective contraception result during treatment with study drug and for an additional 5 months after the end of treatment with study drug Sexually active males with a female partner of childbearing potential: Subject in combination with his partner refuses to use 2 different forms of effective contraception in order to achieve a highly effective contraception result during treatment with study drug and for an additional 7 months after the end of treatment with study drugMales with a partner who is pregnant: Subject refuses to use a condom during treatment with study drug and for an additional 7 months after the end of treatment with study drugKnown intolerance to calcium supplements or vitamin D productsKnown sensitivity to mammalian cell derived d