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Completed

NCT Number: NCT00254514

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

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.

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Key information

Conditions

Bone Fracture Fractures, Bone Tibia Fractures Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Kuopio, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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)

Treatment and study plan

Somatropin

Drug

Primary outcomes

  1. Time from surgery until fracture has healed

    Time frame: During a 12 month period

Secondary outcomes

  1. Investigator's assessment: fracture healed

  2. Number of fractures healed

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multi-centre, Randomised, Double-blind, Placebocontrolled, Parallel-group Trial Investigating the Efficacy and Safety of Norditropin® SimpleXx® in Tibia Fractures

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Nov 16, 2005
Registry last updated
Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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