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

NCT00254514 | Completed Phase 2

• 1 other identifier: NN1606-1365
• Study Type: interventional
• Target: 407
• Locations: 9 countries
• Sites: 40

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.

Conditions

Bone Fracture; Tibia Fractures

Outcome Measures

Primary Outcomes (1)

• Time from surgery until fracture has healed

  During a 12 month period

Secondary Outcomes (2)

• Investigator's assessment: fracture healed

• Number of fractures healed

Interventions

somatropin DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (40)

Novo Nordisk Investigational Site

Kuopio, 70211, Finland

Location

Novo Nordisk Investigational Site

Oulu, 90029, Finland

Location

Novo Nordisk Investigational Site

Strasbourg, 67400, France

Location

Novo Nordisk Investigational Site

Augsburg, 86156, Germany

Location

Novo Nordisk Investigational Site

Berlin, 13353, Germany

Location

Novo Nordisk Investigational Site

Braunschweig, 38118, Germany

Location

Novo Nordisk Investigational Site

Hamburg, 20246, Germany

Location

Novo Nordisk Investigational Site

Homburg, 66421, Germany

Location

Novo Nordisk Investigational Site

Ludwigshafen, 67071, Germany

Location

Novo Nordisk Investigational Site

Mainz, 55131, Germany

Location

Novo Nordisk Investigational Site

München, 81366, Germany

Location

Novo Nordisk Investigational Site

Münster, 48149, Germany

Location

Novo Nordisk Investigational Site

Offenbach, 63069, Germany

Location

Novo Nordisk Investigational Site

Würzburg, D-97080, Germany

Location

Novo Nordisk Investigational Site

Budapest, 1076, Hungary

Location

Novo Nordisk Investigational Site

Budapest, H-1043, Hungary

Location

Novo Nordisk Investigational Site

Budapest, H-1081, Hungary

Location

Novo Nordisk Investigational Site

Budapest, H-1125, Hungary

Location

Novo Nordisk Investigational Site

Győr, 9024, Hungary

Location

Novo Nordisk Investigational Site

Miskolc, H-3526, Hungary

Location

Novo Nordisk Investigational Site

Veszprém, H-8200, Hungary

Location

Novo Nordisk Investigational Site

Beersheba, 84101, Israel

Location

Novo Nordisk Investigational Site

Haifa, 31096, Israel

Location

Novo Nordisk Investigational Site

Jerusalem, 91120, Israel

Location

Novo Nordisk Investigational Site

Kfar Save, 44281, Israel

Location

Novo Nordisk Investigational Site

Tel Aviv, 64239, Israel

Location

Novo Nordisk Investigational Site

Lillestrøm, 2004, Norway

Location

Novo Nordisk Investigational Site

Oslo, 0407, Norway

Location

Novo Nordisk Investigational Site

Gorzów, 66-400, Poland

Location

Novo Nordisk Investigational Site

Krakow, 31-826, Poland

Location

Novo Nordisk Investigational Site

Piekary Śląskie, 41-940, Poland

Location

Novo Nordisk Investigational Site

Sosnowiec, 41-200, Poland

Location

Novo Nordisk Investigational Site

Szczecin-Zdunowo, 70-890, Poland

Location

Novo Nordisk Investigational Site

Durban, KwaZulu-Natal, 4001, South Africa

Location

Novo Nordisk Investigational Site

Cape Town, Western Cape, 7505, South Africa

Location

Novo Nordisk Investigational Site

Cape Town, Western Cape, 7925, South Africa

Location

Novo Nordisk Investigational Site

Cape Town, Western Cape, South Africa

Location

Novo Nordisk Investigational Site

Worcester, 6850, South Africa

Location

Novo Nordisk Investigational Site

Madrid, 28041, Spain

Location

Novo Nordisk Investigational Site

Valencia, 46026, Spain

Location

Related Publications (2)

• 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. doi: 10.1530/EJE-06-0598.

  PMID: 17322494 RESULT

• Krusenstjerna-Hafstrom 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. doi: 10.1016/j.ghir.2011.08.003. Epub 2011 Oct 1.

  PMID: 21963127 DERIVED

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Fractures, Bone

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2005
• First Posted: November 16, 2005
• Study Start: August 1, 2001
• Primary Completion: October 1, 2003
• Study Completion: October 1, 2003
• Last Updated: January 23, 2017

Record last verified: 2017-01

Locations

NO (2); DE (11); IL (5); FI (2); FR (1); PL (5); ES (2); HU (7); ZA (5)