Evidence map›Paper›PMID 32557273›Full record

Observational studyJournal of endocrinological investigation2021

Safety and effectiveness of a somatropin biosimilar in children requiring growth hormone treatment: second analysis of the PATRO Children study Italian cohort.

L Iughetti, F Antoniazzi, C Giavoli, G Bona, T Aversa, N A Greggio, L Guazzarotti, R Minelli, L Perrone, L Persani and 9 more

Open access · greenAbstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Journal of endocrinological investigation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.1field-weighted citation impact, top 57% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
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

19 authors at 15 institutions in 1 country.

L IughettiPediatric Unit, Department of Medical and Surgical Sciences for Mother, Children and Adults, University of Modena and Reggio Emilia, Via del Pozzo, 41124, Modena, Italy. lorenzo.iughetti@unimore.it.ORCID http://orcid.org/0000-0003-0370-7872
F AntoniazziUO di Pediatria, Ospedale Donna e Bambino, Dipartimento di Scienze Chirurgiche, Odontostomatologiche e Materno Infantili, Università di Verona, Verona, Italy.
C GiavoliUnità Operativa di Endocrinologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, Dipartimento di Scienze Cliniche e di Comunità, Università di Milano, Milan, Italy.
G BonaDipartimento di Scienze della Salute, Università del Piemonte Orientale, Novara, Italy.
T AversaDepartment of Human Pathology in Adulthood and Childhood, University of Messina, Messina, Italy.
N A GreggioUO di Endocrinologia Pediatrica e Adolescentologia, Dip. Salute della Donna e del Bambino, Az. Ospedaliera-Università di Padova, Padua, Italy.
L GuazzarottiUnita Operativa di Endocrinologia Pediatrica e Adolescentologia Clinica Pediatrica-Università Degli Studi di Padova Azienda Ospedaliera di Padova, Padua, Italy.
R MinelliClinica Pediatrica, Dipartimento Materno Infantile, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy.
L PerroneDipartimento Della Donna, del Bambino e di Chirurgia Generale e Specialistica, Università Degli Studi Luigi Vanvitelli, Naples, Italy.
L PersaniDivision of Endocrine and Metabolic Diseases, IRCCS Istituto Auxologico Italiano, Milan, Italy.
G PozzobonClinica Pediatrica Dipartimento Materno-Infantile IRCCS Ospedale San Raffaele Università Vita-Salute San Raffaele, Milan, Italy.
L RagusaDipartimento Per Il Ritardo Mentale, Unità Operativa di Pediatria e Genetica Medica, Oasi Research Institute-I.R.C.C.S., Troina, Enna, Italy.
S StagiClinica Pediatrica I, Auxoendocrinologia e Ginecologia Pediatrica, AOU Meyer, Florence, Italy.
G TorneseClinica Pediatrica Ospedale "Burlo Garofalo" di Trieste, Trieste, Italy.
C ZecchinoDipartimento di Scienze Biomediche Ed Oncologia Umana, AO Policlinico di Bari Ospedale Giovanni XXIII, Bari, Italy.
P GallinariSandoz S.P.A, Origgio, Italy.
H ZouaterSandoz Biopharmaceutical C/O HEXAL AG, Holzkirchen, Germany.
P FedeliSandoz S.P.A, Origgio, Italy.
S ZucchiniUnit of Pediatric Endocrinology, S.Orsola-Malpighi Hospital, Bologna, Italy.
Azienda Ospedale - Università Padova · ITFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITIRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola · ITIRCCS Materno Infantile Burlo Garofolo · ITMeyer Children's Hospital · ITOasi Maria SS · ITOspedale di Parma · ITOspedale Pediatrico Giovanni XXIII · ITUniversità degli Studi del Piemonte Orientale “Amedeo Avogadro” · ITUniversity of Campania "Luigi Vanvitelli" · ITUniversity of Messina · ITUniversity of Milan · ITUniversity of Modena and Reggio Emilia · ITUniversity of Padua · ITVita-Salute San Raffaele University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo investigate the long-term safety (primary endpoint) and effectiveness (secondary endpoint) of the somatropin biosimilar Omnitrope

methodsPATRO Children is an ongoing, multicenter, observational, post-marketing surveillance study. Children who received Omnitrope

resultsA total of 291 patients (mean age 10.0 years, 56.0% male) were enrolled at 19 sites in Italy. The mean duration of Omnitrope

conclusionsIn this sub-analysis of PATRO Children, Omnitrope

Indexed as

Biosimilar PharmaceuticalsChildFemaleFollow-Up StudiesGrowth DisordersHuman Growth HormoneHumansLongitudinal StudiesMaleProduct Surveillance, PostmarketingPrognosisBiosimilar PharmaceuticalsHuman Growth HormoneAdolescentsChildrenInfantsOmnitrope®PediatricRecombinant human growth hormone

Identifiers

PMID32557273
OpenAlexW3036798022

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.