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

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00254514

Purpose

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	Intervention	Phase
Tibia Fractures	Drug: somatropin	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Efficacy and Safety of Growth Hormone (Norditropin® SimpleXx®) on Fracture Healing in Tibia Fractures Treated Surgically With Intramedullary Nailing

Resource links provided by NLM:

MedlinePlus related topics: Fractures

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Time from surgery until fracture has healed [ Time Frame: during a 12 month period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Investigator's assessment: fracture healed [ Designated as safety issue: No ]
Number of fractures healed [ Designated as safety issue: No ]

Enrollment:	407
Study Start Date:	August 2001
Study Completion Date:	October 2003
Primary Completion Date:	October 2003 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254514

Locations

Germany

Berlin, Germany
Israel

Beer Sheva, Israel
South Africa

Cape Town, South Africa

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Anders Dejgaard, MD

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided by Novo Nordisk

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Krusenstjerna-Hafstrøm T, Rasmussen MH, Raschke M, Govender S, Madsen J, Christiansen JS. Biochemical markers of bone turnover in tibia fracture patients randomly assigned to growth hormone (GH) or placebo injections: Implications for detection of GH abuse. Growth Horm IGF Res. 2011 Dec;21(6):331-5. Epub 2011 Oct 1.

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00254514 History of Changes
Other Study ID Numbers:	NN1606-1365
Study First Received:	November 15, 2005
Last Updated:	June 17, 2009
Health Authority:	South Africa: Medicines Control Council; Israel: Israeli Health Ministry Pharmaceutical Administration; Germany: German Agency of Medicines

Additional relevant MeSH terms:

Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on February 09, 2012