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Clinical Trials/EUCTR2010-021395-28-ES
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

Sponsor
illy S.A.

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