EUCTR2010-021395-28-ESActive, not recruitingPhase 1
Effect of Teriparatide on Femoral Neck Fracture Healing - GHD
illy S.A.0 sites122 target enrollmentStarted: November 22, 2011Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 122
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Community dwelling men and postmenopausal women aged ?50 years who were ambulatory before sustaining a low-trauma, unilateral femoral neck fracture
- •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
- •Have given written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 610
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 610
Exclusion Criteria
- •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
- •Polytrauma patients and patients with fracture at more thatn 1 site.
Investigators
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