Second study on the Effect of Teriparatide on Femoral Neck Fracture Healing
- Conditions
- hip fracturesurgical intervention10017322
- Registration Number
- NL-OMON39475
- Lead Sponsor
- Eli Lilly
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
Community dwelling men and postmenopausal women aged >=50 years who were ambulatory before sustaining a low-trauma, unilateral femoral neck fracture (displaced or non-displaced) ;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 a part of this protocol);Have given written informed consent (patient or proxy) after being informed of the risks, medications and study procedures
Increased baseline risk of osteosarcoma;History of unresolved skeletal diseases affecting bone metabolism other than primary osteoporosis and any secondary causes of osteoporosis ;Abnormally elevated values of serum calcium at baseline ;Abnormally elevated values of serum intact parathyroid hormone (PTH) (1-84) at baseline ;Severe vitamin D deficiency at baseline defined as 25-hydroxy-vitamin D levels <9.2 ng/mL;Active liver disease or jaundice;Significantly impaired renal function at baseline ;Abnormal thyroid function not corrected by therapy;History of a malignant neoplasm in the 5 years prior to Visit 1, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated.;History of bone marrow or solid-organ transplantation;History of symptomatic nephrolithiasis or urolithiasis in 1 year prior to visit;Prior treatment with PTH, teriparatide or other PTH analogs;Local or systemic treatment with bone morphogenic proteins or any growth factor;Previous fracture or bone surgery in the currently fractured hip;Treatment with bone grafting or osteotomies;Soft tissue infection at the operation site;Treatment with augmentation using any type of degradable cement, hydroxyapatite-coated implants or with non-invasive interventations;Associated major injuries of a lower exteremity including fractures of teh foot, ankle, tibia, fibula, knee, femur, femoral head, or pelvis; dislocations of the ankle, knee, or hip.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>men and postmenopausal women >=50 years of age with successful fracture healing<br /><br>12 months after a hip fracture. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Patient Questionnaires outcome</p><br>