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Safety and Appropriateness of Growth hormone treatments in Europe

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.

Field of science

  • /medical and health sciences/health sciences/public and environmental health
  • /social sciences/sociology/demography/mortality
  • /medical and health sciences/clinical medicine/oncology/cancer
  • /natural sciences/computer and information sciences/data science/data analysis

Call for proposal

FP7-HEALTH-2007-B
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
Address
3 Avenue Victoria
75000 Paris
France
Activity type
Research Organisations
EU contribution
€ 627 312
Administrative Contact
Christophe Misse (Mr.)

Participants (9)

CLINIQUES UNIVERSITAIRES SAINT-LUC
Belgium
EU contribution
€ 249 563
Address
Avenue Hippocrate 10
1200 Bruxelles
Activity type
Research Organisations
Administrative Contact
Michel Van Hassel (Mr.)
UNIVERSITAET LEIPZIG
Germany
EU contribution
€ 320 366
Address
Ritterstrasse 26
04109 Leipzig
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Wieland Kiess (Prof.)
STICHTING KIND EN GROI
Netherlands
EU contribution
€ 205 118
Address
Westzeedijk 106
3016 AH Rotterdam
Activity type
Research Organisations
Administrative Contact
Anita Hokken-Koelega (Prof.)
UNIVERSITA DEGLI STUDI DI ROMA TOR VERGATA
Italy
EU contribution
€ 443 442
Address
Via Cracovia 50
00133 Roma
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Massimo Andreoni (Prof.)
KAROLINSKA INSTITUTET
Sweden
EU contribution
€ 418 291
Address
Nobels Vag 5
17177 Stockholm
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Thomas Walstam (Mr.)
UNIVERSITAET BERN
Switzerland
EU contribution
€ 205 180
Address
Hochschulstrasse 6
3012 Bern
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Primus-Eugen, Josef Mullis (Prof.)
UCL Elizabeth Garrett Anderson Institute for Women’s Health
United Kingdom
EU contribution
€ 233 339
Address
Gower Street
WC1E 6BT London
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Greta Borg-Carbott (Ms.)
THE UNIVERSITY OF MANCHESTER
United Kingdom
EU contribution
€ 134 792
Address
Oxford Road
M13 9PL Manchester
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Liz Fay (Ms.)
THE INSTITUTE OF CANCER RESEARCH: ROYAL CANCER HOSPITAL
United Kingdom
EU contribution
€ 151 751
Address
Old Brompton Road 123
SW7 3RP London
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Lydia Turner (Ms.)