| :: About Projects |
Safety and appropriateness of Growth hormone treatments in Europe
Start date:2009-06-01
End date:2012-11-30
Project Acronym:SAGHE
Project status:Completed
Coordinator
| Organization name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS | |
| Administrative contact | Address |
|
Name:Christophe |
3 Avenue Victoria PARIS FRANCE Region:ÎLE DE FRANCE Ile de France Paris |
| Tel:+33-144841770 | |
| Fax:+33-144841788 | |
| E-mail:Contact | |
| URL:http://www.aphp.fr | Organization Type:Education,Other |
Description
Objective:
Recombinant growth hormone (GH) has been used since 1985. Current indications for GH use in children include GH deficiency and an increasing number of conditions where childhood short stature is not primarily due to deficient GH secretion.
Approximately 40 000 children in the EU are treated with daily injections of GH. The efficacy of GH to increase adult height is undisputed in children with severe GH deficiency but is more limited in other indications where current estimates suggest a gain of about 1 cm of adult height per year of treatment. The clinical significance of height gains has been poorly evaluated. The possibility has been raised that GH use in childhood might increase the risk of cancer later in life. However, little data is available to further explore this concern.
SAGhE is an integrated consortium of paediatric endocrinologist, epidemiologists and biostatisticians that will collect and analyse data to address the questions of appropriateness and safety of childhood GH treatments. The impact on both height and psychosocial components will be evaluated on a large unbiased metacohort of patients followed to adult height. Safety will be evaluated by analysing long term mortality and long term cancer incidence.
The data obtained will then be integrated and disseminated to several levels of users. SAGhE will contribute to the aims of the FP7 Health work programme and to the new Community Action programme of public Health in the field of better use of medicines. It will realize the application of evidence-based medicine in Europe, by the size and design of the study, the independence and scientific quality of data analysis and its translation into evidence-based guidelines. It will be comprehensive at the EU level and will test for national differences. It will address patient safety, one of the key points of the work programme.
SAGhE is unique worldwide in its design, size and potential to answer important questions raised on childhood GH treatments.
Achievements:
General information:
Project Details
Start date:2009-06-01
End date:2012-11-30
Duration:42 months
Project Reference:223497
Project cost:3878026 EURO
Project Funding:2989154 EURO
Programme Acronym:
FP7-HEALTH
Programme type:Seventh Framework Programme
Subprogramme Area:Better use of medicines
Contract type:Small or medium-scale focused research project
URL:
Subject index:Medicine, Health
Other Indexes:safety,Growth hormone,short stature,psychosocial impact,cancer risk
Other participants
| Organization name:THE UNIVERSITY OF MANCHESTER | |
| Administrative contact | Address |
|
Name:Liz |
OXFORD ROAD MANCHESTER UNITED KINGDOM Region:NORTH WEST (UK) GREATER MANCHESTER |
| Tel:+44-1612757114 | |
| Fax:+44-1612752445 | |
| E-mail:Contact | |
| URL:http://www.manchester.ac.uk | Organization Type: |
| Organization name:KAROLINSKA INSTITUTET | |
| Administrative contact | Address |
|
Name:Thomas |
Nobels Vag STOCKHOLM SVERIGE Region:SVERIGE STOCKHOLM |
| Tel:+46-851773487 | |
| Fax:+46-851771774 | |
| E-mail:Contact | |
| URL:http://www.ki.se | Organization Type: |
| Organization name:UNIVERSITY COLLEGE LONDON | |
| Administrative contact | Address |
|
Name:Greta |
Gower Street LONDON UNITED KINGDOM Region:SOUTH EAST (UK) GREATER LONDON |
| Tel:+44-2076796135 | |
| Fax:+44-2078132849 | |
| E-mail:Contact | |
| URL:http://www.ucl.ac.uk | Organization Type:Education,Other |
| Organization name:UNIVERSITAET LEIPZIG | |
| Administrative contact | Address |
|
Name:Wieland |
RITTERSTRASSE LEIPZIG DEUTSCHLAND Region:SACHSEN Leipzig, Kreisfreie Stadt |
| Tel:+49-3419726330 | |
| Fax:+49-3419726349 | |
| E-mail:Contact | |
| URL:http://www.uni-leipzig.de | Organization Type: |
| Organization name:INSTITUTE OF CANCER RESEARCH - ROYAL CANCER HOSPITAL | |
| Administrative contact | Address |
|
Name:Lydia |
Old Brompton Road 123 LONDON UNITED KINGDOM Region:SOUTH EAST (UK) GREATER LONDON |
| Tel:+44-2071535219 | |
| Fax:+44-2071535534 | |
| E-mail:Contact | |
| URL:http://www.icr.ac.uk | Organization Type: |
| Organization name:UNIVERSITA DEGLI STUDI DI ROMA TOR VERGATA | |
| Administrative contact | Address |
|
Name:Massimo |
VIA ORAZIO RAIMONDO ROMA ITALIA Region:LAZIO Roma |
| Tel:+39-06-72592226 | |
| Fax:+39-06-7236605 | |
| E-mail:Contact | |
| URL: | Organization Type: |
| Organization name:CLINIQUES UNIVERSITAIRES SAINT-LUC | |
| Administrative contact | Address |
|
Name:Michel |
AVENUE HIPPOCRATE BRUXELLES BELGIQUE-BELGIË Region:REG.BRUXELLES-CAP./BRUSSELS HFDST. GEW. |
| Tel:+32-27641510 | |
| Fax:+32-27641501 | |
| E-mail:Contact | |
| URL:http://www.saintluc.be | Organization Type: |
| Organization name:STICHTING KIND EN GROI | |
| Administrative contact | Address |
|
Name:Anita |
WESTZEEDIJK ROTTERDAM NEDERLAND Region:WEST-NEDERLAND ZUID-HOLLAND Groot-Rijnmond |
| Tel:+31-102251533 | |
| Fax:+31-102250133 | |
| E-mail:Contact | |
| URL:http://www.groeistichting.nl | Organization Type: |
| Organization name:UNIVERSITAET BERN | |
| Administrative contact | Address |
|
Name:Primus-eugen, Josef |
Hochschulstrasse BERN SCHWEIZ/SUISSE/SVIZZERA Region:ESPACE MITTELLAND Bern |
| Tel:+41-316329552 | |
| Fax:+41-316329550 | |
| E-mail:Contact | |
| URL:http://www.unibe.ch | Organization Type: |
Record control number:91240
