Controlled Study to Evaluate the Efficacy and Safety of the Treatment With Growth Hormone in Tibia Fractures

Phase 2

Completed

• Conditions: Tibia Fractures; Bone Fracture

• Registration Number: NCT00254514
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Africa, Europe and Middle East. This trial investigates the efficacy and safety of three dose levels of Norditropin® (growth hormone) as compared to placebo in the treatment of tibia fractures. The trial will be conducted in two parts: in the first part, the patients will be evaluated with regard to efficacy (fracture healing) and safety at short time intervals until week 24 post-surgery. In the second part, long-term safety and fracture healing up to 12 months post-surgery will be evaluated.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-08
• Primary Completion: 2003-10
• Study Completion: 2003-10
• Study First Submitted: 2005-11-15
• Study First Submitted QC: 2005-11-15
• Study First Posted: 2005-11-16
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-20
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 407

Inclusion Criteria

• Primary surgical treatment of tibia fracture using intramedullary nailing
• Closed fractures: Tscherne Type C1, C2 and C3
• Open fractures: Gustilo Grade I, II and IIIa

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Exclusion Criteria

• Open growth plate on X-rays
• Known chronic endocrine or metabolic disease including diabetes and severe obesity defined as body mass index (BMI)1 > 32.0
• Severe head injury defined as patients who are stuporous or comatose with pupillary enlargement or asymmetry
• Critically ill patients defined as patients in need of mechanical ventilation (except during surgical procedures) or circulatory support (defined as use of inotropic drugs)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time from surgery until fracture has healed	During a 12 month period

Secondary Outcome Measures

Name	Time	Method
Investigator's assessment: fracture healed
Number of fractures healed

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇪🇸 Valencia, Spain