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Endocr Connect. 2018 Mar;7(3):R126-R134. doi: 10.1530/EC-18-0047. Epub 2018 Feb 26.

Growth Hormone Research Society perspective on biomarkers of GH action in children and adults.

Author information

1
Department of Internal Medicine and Clinical NutritionSahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
2
Medizinische Klinik und Poliklinik IVKlinikum der Universität München, Munich, Germany.
3
Neuroendocrine UnitMassachusetts General Hospital, Boston, Massachusetts, USA.
4
Federal University of ParanaCuritiba, Brazil.
5
Department of MedicineComplejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.
6
Assistance Publique-Hôpitaux de Parisand Inserm, Paris, France.
7
Developmental Biology & MedicineFaculty of Biology, Medicine & Health, University of Manchester, Manchester, UK.
8
Department of EndocrinologyPrincess Margaret Hospital & School of Medicine, University of Western Australia, Western Australia, Australia.
9
Department of MedicineUniversity of North Carolina, Chapel Hill, North Carolina, USA.
10
Great Ormond Street Institute of Child HealthLondon, UK.
11
Department of EndocrinologyOdense University Hospital, Odense, Denmark.
12
Princess Alexandra Hospital and University of QueenslandBrisbane, Australia.
13
Department of MedicineStanford University and VA Palo Health Care System, Palo Alto, California, USA.
14
National Center for Child Health and DevelopmentTokyo, Japan.
15
Department of Growth and ReproductionRigshospitalet, University of Copenhagen, Copenhagen, Denmark.
16
Edison Biotechnology Institute and Heritage College of Osteopathic MedicineOhio University, Athens, Ohio, USA.
17
Department of PediatricsTongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
18
Section of EndocrinologyDepartment of Medicine, Pituitary Centre Rotterdam, Erasmus University Medical Centre, Rotterdam, the Netherlands.
19
Service d'Explorations Fonctionnelles EndocriniennesAP-HP, Hôpital Trousseau, Sorbonne Université, INSERM UMRs 938, Paris, France.
20
Department of EndocrinologyInstitute of Medicine, Sahlgrenska Academy, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden.
21
Rutgers University-Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey, USA.
22
Department of PediatricsOregon Health Science University, Portland, Oregon, USA.
23
University of SheffieldSheffield, UK.
24
Universidade do Estado do Rio de JaneiroRio de Janeiro, Brazil.
25
Charité-UniversitätsmedizinBerlin, Germany.
26
The Christie NHS Foundation TrustUniversity of Manchester, Manchester, UK.
27
Barrow Pituitary CenterBarrow Neurological Institute, Department of Neuroendocrinology, University of Arizona College of Medicine, Phoenix, Arizona, USA.
28
Medical Products AgencyUppsala, Sweden.
29
Aarhus University HospitalAarhus, Denmark joj@clin.au.dk.

Abstract

OBJECTIVE:

The Growth Hormone Research Society (GRS) convened a Workshop in 2017 to evaluate clinical endpoints, surrogate endpoints and biomarkers during GH treatment of children and adults and in patients with acromegaly.

PARTICIPANTS:

GRS invited 34 international experts including clinicians, basic scientists, a regulatory scientist and physicians from the pharmaceutical industry.

EVIDENCE:

Current literature was reviewed and expert opinion was utilized to establish the state of the art and identify current gaps and unmet needs.

CONSENSUS PROCESS:

Following plenary presentations, breakout groups discussed questions framed by the planning committee. The attendees re-convened after each breakout session to share the group reports. A writing team compiled the breakout session reports into a document that was subsequently discussed and revised by participants. This was edited further and circulated for final review after the meeting. Participants from pharmaceutical companies were not part of the writing process.

CONCLUSIONS:

The clinical endpoint in paediatric GH treatment is adult height with height velocity as a surrogate endpoint. Increased life expectancy is the ideal but unfeasible clinical endpoint of GH treatment in adult GH-deficient patients (GHDA) and in patients with acromegaly. The pragmatic clinical endpoints in GHDA include normalization of body composition and quality of life, whereas symptom relief and reversal of comorbidities are used in acromegaly. Serum IGF-I is widely used as a biomarker, even though it correlates weakly with clinical endpoints in GH treatment, whereas in acromegaly, normalization of IGF-I may be related to improvement in mortality. There is an unmet need for novel biomarkers that capture the pleiotropic actions of GH in relation to GH treatment and in patients with acromegaly.

KEYWORDS:

GH; GH deficiency; IGF-I; acromegaly

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