Fractuurgenezing bone growth stimulation Fracture healing
Conditions
Interventions
240 Patients globally will receive 3 dosis of either 70 mg AMG 785, 140 mg AMG
785 or 210 mg AMG 785, if the patient will finish the study.
Sponsors
Amgen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Adult women or men, age >= 55 to
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 that has not been surgically corrected. If surgically corrected, the subject must be asymtomatic to be eligible for the study -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 severe 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 -hypocalcemia or hypercalcemia, outside of 1.1 x the normal range set by the local laboratory -Use of the following agents affecting bone metabolism •Within the past 12 months: parathyroid hormone, strontium, fluoride (for osteoporosis) •Within the past 6 months: IV bisphosphonates, denosumab, odanacatib (MK-0822) •WIthin the past 3 months: calcitonin, tibolone, cinacalcet, systemic glucocorticosteroids (>=5 mg prednisone equivalent per day for more than 10 days) -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, pins, plates) to either hip or lower spine -Subject has known sensitivity to any of the products to be administered (calcium supplements, vitamin D products, or mammalian cell derived products)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 energetic hip (intertrochanteric or femoral neck) fracture (refer to Appendix F for description of TUG procedure). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Netherlands
Outcome results
None listed