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NCT00254514 Clinical Trial

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

Bone Fracture Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00254514
Other study ID # NN1606-1365
Secondary ID
Status Completed
Phase Phase 2
First received November 15, 2005
Last updated January 20, 2017
Start date August 2001
Est. completion date October 2003

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 407
Est. completion date October 2003
Est. primary completion date October 2003
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• somatropin

Locations
Country Name City State
Finland Novo Nordisk Investigational Site Kuopio
Finland Novo Nordisk Investigational Site Oulu
France Novo Nordisk Investigational Site Strasbourg
Germany 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 Novo Nordisk Investigational Site München
Germany Novo Nordisk Investigational Site Münster
Germany Novo Nordisk Investigational Site Offenbach
Germany Novo Nordisk Investigational Site Würzburg
Hungary Novo Nordisk Investigational Site Budapest
Hungary Novo Nordisk Investigational Site Budapest
Hungary Novo Nordisk Investigational Site Budapest
Hungary Novo Nordisk Investigational Site Budapest
Hungary Novo Nordisk Investigational Site Gyor
Hungary Novo Nordisk Investigational Site Miskolc
Hungary Novo Nordisk Investigational Site Veszprém
Israel Novo Nordisk Investigational Site Beer Sheva
Israel Novo Nordisk Investigational Site Haifa
Israel Novo Nordisk Investigational Site Jerusalem
Israel Novo Nordisk Investigational Site Kfar Save
Israel Novo Nordisk Investigational Site Tel-Aviv
Norway Novo Nordisk Investigational Site Lillestrøm
Norway Novo Nordisk Investigational Site Oslo
Poland Novo Nordisk Investigational Site Gorzów
Poland Novo Nordisk Investigational Site Krakow
Poland Novo Nordisk Investigational Site Piekary Slaskie
Poland Novo Nordisk Investigational Site Sosnowiec
Poland Novo Nordisk Investigational Site Szczecin-Zdunowo
South Africa Novo Nordisk Investigational Site Cape Town Western Cape
South Africa Novo Nordisk Investigational Site Cape Town Western Cape
South Africa Novo Nordisk Investigational Site Cape Town Western Cape
South Africa Novo Nordisk Investigational Site Durban KwaZulu-Natal
South Africa Novo Nordisk Investigational Site Worcester
Spain Novo Nordisk Investigational Site Madrid
Spain Novo Nordisk Investigational Site Valencia

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Finland,  France,  Germany,  Hungary,  Israel,  Norway,  Poland,  South Africa,  Spain, 

References & Publications (1)

Raschke M, Rasmussen MH, Govender S, Segal D, Suntum M, Christiansen JS. Effects of growth hormone in patients with tibial fracture: a randomised, double-blind, placebo-controlled clinical trial. Eur J Endocrinol. 2007 Mar;156(3):341-51. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Time from surgery until fracture has healed During a 12 month period
Secondary Investigator's assessment: fracture healed
Secondary Number of fractures healed
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