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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00254514
Recruitment Status : Completed
First Posted : November 16, 2005
Last Update Posted : January 23, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bone Fracture Tibia Fractures Drug: somatropin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 407 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-centre, Randomised, Double-blind, Placebocontrolled, Parallel-group Trial Investigating the Efficacy and Safety of Norditropin® SimpleXx® in Tibia Fractures
Study Start Date : August 2001
Actual Primary Completion Date : October 2003
Actual Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Time from surgery until fracture has healed [ Time Frame: During a 12 month period ]

Secondary Outcome Measures :
  1. Investigator's assessment: fracture healed
  2. Number of fractures healed

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00254514

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Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S