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

Primary Purpose

Bone Fracture, Tibia Fractures

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
somatropin
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Fracture

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Outcomes

Primary Outcome Measures

Time from surgery until fracture has healed

Secondary Outcome Measures

Investigator's assessment: fracture healed
Number of fractures healed

Full Information

First Posted
November 15, 2005
Last Updated
January 20, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00254514
Brief Title
Controlled Study to Evaluate the Efficacy and Safety of the Treatment With Growth Hormone in Tibia Fractures
Official Title
A Multi-centre, Randomised, Double-blind, Placebocontrolled, Parallel-group Trial Investigating the Efficacy and Safety of Norditropin® SimpleXx® in Tibia Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
October 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Fracture, Tibia Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
407 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
somatropin
Primary Outcome Measure Information:
Title
Time from surgery until fracture has healed
Time Frame
During a 12 month period
Secondary Outcome Measure Information:
Title
Investigator's assessment: fracture healed
Title
Number of fractures healed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Oulu
ZIP/Postal Code
90029
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Strasbourg
ZIP/Postal Code
67400
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Braunschweig
ZIP/Postal Code
38118
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Ludwigshafen
ZIP/Postal Code
67071
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
München
ZIP/Postal Code
81366
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Offenbach
ZIP/Postal Code
63069
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Würzburg
ZIP/Postal Code
D-97080
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
H-1043
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
H-1081
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
H-1125
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Miskolc
ZIP/Postal Code
H-3526
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Veszprém
ZIP/Postal Code
H-8200
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Kfar Save
ZIP/Postal Code
44281
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Lillestrøm
ZIP/Postal Code
2004
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Gorzów
ZIP/Postal Code
66-400
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Krakow
ZIP/Postal Code
31-826
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Piekary Slaskie
ZIP/Postal Code
41-940
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Sosnowiec
ZIP/Postal Code
41-200
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Szczecin-Zdunowo
ZIP/Postal Code
70-890
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Cape Town
State/Province
Western Cape
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Worcester
ZIP/Postal Code
6850
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
17322494
Citation
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.
Results Reference
result
PubMed Identifier
21963127
Citation
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.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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