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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00254514
• Collaborator: (none)
• Enrollment: 407
• Locations: 40
• Duration (Months): 26
• Patients Per Site: 10.2
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Fracture; Tibia Fractures	Drug: somatropin	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 407 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multi-centre, Randomised, Double-blind, Placebocontrolled, Parallel-group Trial Investigating the Efficacy and Safety of Norditropin® SimpleXx® in Tibia Fractures
• Study Start Date: Aug 1, 2001
• Actual Primary Completion Date: Oct 1, 2003
• Actual Study Completion Date: Oct 1, 2003

Outcome Measures

Primary Outcome Measures

1. Time from surgery until fracture has healed [During a 12 month period]

Secondary Outcome Measures

1. Investigator's assessment: fracture healed []

2. Number of fractures healed []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Kuopio		Finland	70211
2	Novo Nordisk Investigational Site	Oulu		Finland	90029
3	Novo Nordisk Investigational Site	Strasbourg		France	67400
4	Novo Nordisk Investigational Site	Augsburg		Germany	86156
5	Novo Nordisk Investigational Site	Berlin		Germany	13353
6	Novo Nordisk Investigational Site	Braunschweig		Germany	38118
7	Novo Nordisk Investigational Site	Hamburg		Germany	20246
8	Novo Nordisk Investigational Site	Homburg		Germany	66421
9	Novo Nordisk Investigational Site	Ludwigshafen		Germany	67071
10	Novo Nordisk Investigational Site	Mainz		Germany	55131
11	Novo Nordisk Investigational Site	München		Germany	81366
12	Novo Nordisk Investigational Site	Münster		Germany	48149
13	Novo Nordisk Investigational Site	Offenbach		Germany	63069
14	Novo Nordisk Investigational Site	Würzburg		Germany	D-97080
15	Novo Nordisk Investigational Site	Budapest		Hungary	1076
16	Novo Nordisk Investigational Site	Budapest		Hungary	H-1043
17	Novo Nordisk Investigational Site	Budapest		Hungary	H-1081
18	Novo Nordisk Investigational Site	Budapest		Hungary	H-1125
19	Novo Nordisk Investigational Site	Gyor		Hungary	9024
20	Novo Nordisk Investigational Site	Miskolc		Hungary	H-3526
21	Novo Nordisk Investigational Site	Veszprém		Hungary	H-8200
22	Novo Nordisk Investigational Site	Beer Sheva		Israel	84101
23	Novo Nordisk Investigational Site	Haifa		Israel	31096
24	Novo Nordisk Investigational Site	Jerusalem		Israel	91120
25	Novo Nordisk Investigational Site	Kfar Save		Israel	44281
26	Novo Nordisk Investigational Site	Tel-Aviv		Israel	64239
27	Novo Nordisk Investigational Site	Lillestrøm		Norway	2004
28	Novo Nordisk Investigational Site	Oslo		Norway	0407
29	Novo Nordisk Investigational Site	Gorzów		Poland	66-400
30	Novo Nordisk Investigational Site	Krakow		Poland	31-826
31	Novo Nordisk Investigational Site	Piekary Slaskie		Poland	41-940
32	Novo Nordisk Investigational Site	Sosnowiec		Poland	41-200
33	Novo Nordisk Investigational Site	Szczecin-Zdunowo		Poland	70-890
34	Novo Nordisk Investigational Site	Durban	KwaZulu-Natal	South Africa	4001
35	Novo Nordisk Investigational Site	Cape Town	Western Cape	South Africa	7505
36	Novo Nordisk Investigational Site	Cape Town	Western Cape	South Africa	7925
37	Novo Nordisk Investigational Site	Cape Town	Western Cape	South Africa
38	Novo Nordisk Investigational Site	Worcester		South Africa	6850
39	Novo Nordisk Investigational Site	Madrid		Spain	28041
40	Novo Nordisk Investigational Site	Valencia		Spain	46026

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT00254514
• Other Study ID Numbers: NN1606-1365
• First Posted: Nov 16, 2005
• Last Update Posted: Jan 23, 2017
• Last Verified: Jan 1, 2017

• Additional relevant MeSH terms: Fractures, Bone; Tibial Fractures

Study Results

No Results Posted as of Jan 23, 2017