Acceleration of fracture healing
Conditions
Interventions
Product Name: AMG 785
Product Code: AMG 785
Pharmaceutical Form: Solution for injection
INN or Proposed INN: AMG 785
Current Sponsor code: AMG 785
Concentration unit: mg/ml milligram(s)/millilitre
Con
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult women or men, age = 55 to = 90 years at randomization Fresh unilateral low energy intertrochanteric fracture of the proximal femur as the primary injury, confirmed by X-ray Fractures eligible for this study must have one of the following characteristics • At least three fragments, each with displacement = 1 cm • Extension into the subtrochanteric region Internal fixation of the fracture with a sliding hip screw or IM nail (devices approved by local regulatory agency), performed no later than 5 days after injury Pre- and postoperative care performed as defined in Appendix J of the protocol Subject or subject’s legally acceptable representative has provided informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Conditions that may affect the ability to perform functional or clinical assessments required by the protocol, such as: • Severe symptomatic osteoarthritis of the lower extremity • Inability to independently rise from armchair or walk 200 meters before hip fracture (use of unilateral assistive device or rolling walker is acceptable) • Cognitive deficit, as defined by Mini-Mental Status Examination score 16 Pathological fracture or history of metabolic or bone disease that may interfere with the interpretation of the results, such as Paget’s disease, rheumatoid arthritis, osteomalacia, osteopetrosis, ankylosing spondylitis, Cushing’s disease, hyperprolactinemia History of symptomatic spinal stenosis History of facial nerve paralysis Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical carcinoma in situ) within the last 5 years Severe asthma or chronic obstructive pulmonary disease or recent exacerbation Myocardial infarction or unstable angina pectoris within the last 12 months Current alcohol dependence History of solid organ or bone marrow transplants Evidence of the following per subject report, chart review or local laboratory result (currently or within the past 5 years) • Elevated transaminases (a) Serum aspartate aminotransferase = 2.0 x upper limits of normal; (b) Serum alanine aminotransferase = 2.0 x upper limits of normal • Significantly impaired renal function as determined by a derived creatinine clearance of = 30 mL/min using the Modification of Diet in Renal Disease equation (Levey et al, 1999). The estimated glomerular filtration rate is calculated as follows: estimated glomerular filtration rate (mL/min/1.73m2) = 186 x [Serum creatinine (mg/dL)]-1.154 x [Age]-0.203 x [0.742 if subject is female] x [1.210 if subject is black]. • Current hypocalcemia or hypercalcemia (= 1.1 x upper limit of the normal range set by the local laboratory, after adequate volume resuscitation, is acceptable for high calcium value) Known to have tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen Use of the following agents affecting bone metabolism • Denosumab within the past 6 months • Fluoride (for osteoporosis) or IV bisphosphonates within the past 12 months • Parathyroid hormone or strontium within the past 12 months • Calcitonin within the past three months • Systemic glucocorticosteroids (= 5 mg prednisone equivalent per day for more than 10 days) within the past three months BMP-2 or BMP-7 at the time of definitive fracture fixation Subjects to be enrolled in DXA sub-study may not have had previous instrumentation with implants (ie, nails, screws,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of AMG 785 compared to placebo on functional healing as measured by the timed-up-and-go test (TUG) over Weeks 6 through 20 in subjects with fresh unilateral low energy intertrochanteric fracture of the proximal femur.;Secondary Objective: To investigate the effect of AMG 785 compared to placebo on: • TUG by visit • Time to radiographic healing • Harris Hip Score • Pain as a result of the hip fracture as assessed by the Visual Analog Scale (VAS);Primary end point(s): The primary endpoint is the difference in mean TUG over Weeks 6 through Week 20 between the AMG 785 and placebo groups. | — |
Countries
Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Netherlands, Poland, Slovenia, Sweden, United Kingdom
Outcome results
None listed