Effect of Teriparatide on Hip Fracture Healing

Phase 1

• Conditions: ow trauma femoral neck fracture; MedDRA version: 14.0Level: LLTClassification code 10068399Term: Trochanteric femoral fractureSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2010-021395-28-ES
• Lead Sponsor: illy S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-22
• Study Completion: 2013-12-04
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified