Effect of Teriparatide on Hip Fracture Healing

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