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Controlled Study to Evaluate the Efficacy and Safety of the Treatment With Growth Hormone in Tibia Fractures | Clinical Trials | Clareo Health

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

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

NCT00254514•Novo Nordisk A/S

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

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)

Locations (40)

Novo Nordisk Investigational Site

Kuopio, Finland

Novo Nordisk Investigational Site

Oulu, Finland

Novo Nordisk Investigational Site

Strasbourg, France

Novo Nordisk Investigational Site

Augsburg, Germany

Novo Nordisk Investigational Site

Berlin, Germany

Novo Nordisk Investigational Site

Braunschweig, Germany

Novo Nordisk Investigational Site

Hamburg, Germany

Novo Nordisk Investigational Site

Homburg, Germany

Novo Nordisk Investigational Site

Ludwigshafen, Germany

Novo Nordisk Investigational Site

Mainz, Germany

Key Dates

Start Date

August 1, 2001

Primary Completion Date

October 1, 2003

Completion Date

October 1, 2003

Last Updated

January 23, 2017

Enrollment

407

ACTUAL participants

Conditions

Bone FractureTibia Fractures

Interventions

somatropin

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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