Health Condition 1: null- Patients with low-trauma femoral neck fracture
Conditions
Interventions
Intervention1: Teriparatide: 20 µg administered once daily by subcutaneous injection for 6 months
Control Intervention1: Placebo: Administered once daily by subcutaneous injection for 6 months
Sponsors
Eli Lilly and Company
Eligibility
Inclusion criteria
Inclusion criteria: -Community dwelling men and postmenopausal women who were ambulatory before sustaining a low-trauma, unilateral femoral neck fracture (displaced or nondisplaced) -Other than femoral neck fracture, be free of incapacitating conditions and have a life expectancy of at least 2 years -Have received or are eligible for treatment with internal fixation (sliding hip screw or multiple cancellous screws) for the femoral neck fracture (the surgical procedure itself is not performed as part of this study) -Have given written informed consent (participant or proxy) after being informed of the risks, medications, and study procedures -There should be 3 or more screws in fixation
Exclusion criteria
Exclusion criteria: -Increased baseline risk of osteosarcoma -History of unresolved skeletal diseases affecting bone metabolism other than primary osteoporosis -Abnormally elevated serum calcium at screening -Abnormally elevated serum intact parathyroid hormone (PTH) (1-84) at screening -Severe vitamin D deficiency at screening -Active liver disease or jaundice -Significantly impaired renal function -Abnormal thyroid function not corrected by therapy -History of malignant neoplasm in the 5 years prior to screening -History of bone marrow or solid organ transplantation -History of symptomatic nephrolithiasis or urolithiasis in the 1 year prior to screening -Previous treatment with the following bone active drugs is allowed but must be discontinued at screening: oral bisphosphonates, selective estrogen receptor modulators (SERMs), calcitonin, estrogen (oral, transdermal, or injectable), progestin, estrogen analog, estrogen agonist, estrogen antagonist or tibolone, and active vitamin D3 analogs. Androgen or other anabolic steroid use must be discontinued, except for use of physiologic replacement testosterone -Previous treatment with the following bone active drugs is exclusionary, if the stated treatment durations have been met: strontium ranelate for any duration, intravenous bisphosphonates in the 12 months preceding screening, and/or denosumab in the 6 months preceding screening -Prior treatment with PTH, teriparatide, or other PTH analogs, or prior participation in any other clinical trial studying PTH, teriparatide, or other PTH analogs -Local or systemic treatment with bone morphogenic proteins or any other growth factor -Previous fracture(s) or bone surgery in the currently fractured hip -Soft-tissue infection at the operation site -Treatment with bone grafting or osteotomies -Treatment with augmentation using any type of degradable cement, hydroxyapatite-coated implants, or with noninvasive interventions -Associated major injuries of a lower extremity including fractures of the foot, ankle, tibia, fibula, knee, femur, femoral head or pelvis; dislocations of the ankle, knee or hip
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with successful femoral neck fracture healing at 24 monthsTimepoint: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in ambulationTimepoint: Baseline, 6 months;Mean change in worst fracture-site painTimepoint: Baseline, 6 months;Mean change on European Quality of Life Questionnaire (EQ-5D)Timepoint: Baseline, 6 months;Mean change on Short Form-12 (SF-12) physical and mental component summary scoresTimepoint: Baseline, 6 months;Mean change on Western Ontario McMaster Osteoarthritis Index (WOMAC)Timepoint: Baseline, 6 months;Percentage of participants able to ambulateTimepoint: Baseline to 24 months;Percentage of participants who regain their prefracture ambulatory statusTimepoint: Baseline to 24 months;Percentage of participants with functional evidence of healingTimepoint: Baseline to 24 months;Percentage of participants with no revision surgeryTimepoint: Baseline to 24 months;Percentage of participants with pain controlTimepoint: Baseline to 24 months;Percentage of participants with radiographic evidence of healingTimepoint: Baseline to 24 months;Percentage of participants without severe fracture-site painTimepoint: Baseline to 24 months;Time to revision surgeryTimepoint: Baseline to 24 months | — |
Countries
Australia, Brazil, Canada, Estonia, Finland, Hong Kong, India, Israel, Japan, Latvia, Lithuania, New Zealand, Norway, Spain, Sweden, Taiwan, Turkey, United States of America
Contacts
Public ContactAnil Seth
Outcome results
None listed