Evidence map›Paper›PMID 29433573›Full record

ArticleBMC endocrine disorders2018

Design of the Growth hormone deficiency and Efficacy of Treatment (GET) score and non-interventional proof of concept study.

Peter H Kann, Simona Bergmann, Martin Bidlingmaier, Christina Dimopoulou, Birgitte T Pedersen, Günter K Stalla, Matthias M Weber, Stefanie Meckes-Ferber

Registry-linked trialAbstract read
In one paragraph

Article in BMC endocrine disorders, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00934063 (A 24-month Prospective, Non-interventional, Observational Study on the Composite Clinical Endpoint), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00934063 completednot on this map

A 24-month Prospective, Non-interventional, Observational Study on the Composite Clinical Endpoint (GET-Score) Reflecting Quality of Life, Body Composition and Cholesterol Metabolism in Patients Treated With Norditropin® (Somatropin)

TypeobservationalSponsorNovo Nordisk A/SRan2009 to 2014Enrolled121ConditionsGrowth Hormone Disorder, Adult Growth Hormone DeficiencyArmssomatropin, No treatment given
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Role of bisphosphonates in osteoporosis caused by adult growth hormone deficiency.Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2024
    Review
  2. Individual sensitivity to growth hormone replacement in adults.Reviews in endocrine & metabolic disorders · 2021
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Peter H KannDivision of Endocrinology & Diabetology, Philipp's University Marburg, D-35033, Marburg, Germany. kannp@med.uni-marburg.de.
Simona BergmannDivision of Endocrinology & Diabetology, Philipp's University Marburg, D-35033, Marburg, Germany.
Martin BidlingmaierEndocrine Laboratory, Medizinische Klinik und Poliklinik IV, Ludwig-Maximilians University, 80336, Munich, Germany.
Christina DimopoulouNeuroendocrinology, Max-Planck-Institute for Psychiatry, 80804, Munich, Germany.
Birgitte T PedersenEpidemiology, Novo Nordisk A/S, 2860, Søborg, Denmark.
Günter K StallaNeuroendocrinology, Max-Planck-Institute for Psychiatry, 80804, Munich, Germany.
Matthias M WeberEndocrinology & Metabolism, Johannes Gutenberg University Hospital, 55131, Mainz, Germany.
Stefanie Meckes-FerberClinical, Medical & Regulatory Department, Novo Nordisk Pharma GmbH, 55127, Mainz, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe adverse effects of growth hormone (GH) deficiency (GHD) in adults (AGHD) on metabolism and health-related quality of life (HRQoL) can be improved with GH substitution. This investigation aimed to design a score summarising the features of GHD and evaluate its ability to measure the effect of GH substitution in AGHD.

methodsThe Growth hormone deficiency and Efficacy of Treatment (GET) score (0-100 points) assessed (weighting): HRQoL (40%), disease-related days off work (10%), bone mineral density (20%), waist circumference (10%), low-density lipoprotein cholesterol (10%) and body fat mass (10%). A prospective, non-interventional, multicentre proof-of-concept study investigated whether the score could distinguish between untreated and GH-treated patients with AGHD. A 10-point difference in GET score during a 2-year study period was expected based on pre-existing knowledge of the effect of GH substitution in AGHD.

resultsOf 106 patients eligible for analysis, 22 were untreated GHD controls (9 females, mean ± SD age 52 ± 17 years; 13 males, 57 ± 13 years) and 84 were GH-treated (31 females, age 45 ± 13 years, GH dose 0.30 ± 0.16 mg/day; 53 males, age 49 ± 15 years, GH dose 0.25 ± 0.10 mg/day). Follow-up was 706 ± 258 days in females and 653 ± 242 days in males. The GET score differed between the untreated control and treated groups with a least squares mean difference of + 10.01 ± 4.01 (p = 0.0145).

conclusionsThe GET score appeared to be a suitable integrative instrument to summarise the clinical features of GHD and measure the effects of GH substitution in adults. Exercise capacity and muscle strength/body muscle mass could be included in the GET score.

trial registrationNCT number: NCT00934063 . Date of registration: 02 July 2009.

Indexed as

Hormone Replacement TherapyProof of Concept StudyAdultAgedBody CompositionBone DensityCase-Control StudiesFemaleFollow-Up StudiesGrowth DisordersHuman Growth HormoneHumansMaleMiddle AgedPrognosisQuality of LifeHuman Growth HormoneClinical studyGrowth hormoneGrowth hormone deficiencyQuality of life

Identifiers

PMID29433573
PMCPMC5810096

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.