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1. Validation and ease of use of a new pen device for self-administration of recombinant human growth hormone: results from a two-center usability study

Author

Rapaport R, Saenger P, Schmidt H, Hasegawa Y, Colle M, Loche S, Marcantonio S, Bonfig W, Zabransky M, and Lifshitz F

Subjects
Medical technology, R855-855.5
Abstract

Robert Rapaport,1 Paul Saenger,2 Heinrich Schmidt,3 Yukihiro Hasegawa,4 Michel Colle,5 Sandro Loche,6 Sandra Marcantonio,7 Walter Bonfig,8 Markus Zabransky,9 Fima Lifshitz10 1Division of Pediatric Endocrinology and Diabetes, Mount Sinai School of Medicine, 2Winthrop University Hospital, Mineola, NY, USA; 3University Children's Hospital, Division of Endocrinology and Diabetology, Munich, Germany; 4Department of Endocrinology and Metabolism, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan; 525 rue Boudet, Bordeaux, France; 6Servizio di Endocrinologia Pediatrica, Ospedale Microcitemico ASL Cagliari, Cagliari, Italy; 7Clinica de Endocrinologia Pediátrica, Londrina, Brazil; 8Division of Pediatric Endocrinology, Technical University München, Munich, Germany; 9Sandoz International GmbH, Holzkirchen, Germany; 10Pediatric Sunshine Academics, Inc, Santa Barbara, CA, USA Abstract: Close adherence to the recommended treatment regimen is important for the success of recombinant human growth hormone therapy, although nonadherence can be common. Ease of use and safety during use/storage are among several important factors in the design of a growth hormone injection device intended for long-term use. This study was performed to validate the usability and assess the ease of use of a new pen device (SurePal™) that has been developed to support daily administration of the recombinant human growth hormone product, Omnitrope® (somatropin). The primary objectives of the study were to assess if study participants, representing intended users of the pen in clinical practice, were able to perform an injection procedure into an injection pad effectively and safely and disassemble the pen without receiving a needlestick injury. A total of 106 participants (61 adults and 45 children/adolescents) were enrolled at two study centers (one in the US, one in Germany). Results for both primary usability tasks met the predefined acceptance criteria, with >85% of participants successfully performing each task. All of the other tasks/handling steps assessed were also successfully performed by most participants, with high success rates reflected in the high proportion of participants who classified each task as "very easy" or "easy". After a second use of the device, 87%–97% of participants rated it as "very easy" or "easy" to use. In summary, the new pen device is safe and easy to use for both adults and children, and will help to support effective, long-term daily administration of the recombinant human growth hormone product, Omnitrope®. Keywords: ease of use, growth hormone, Omnitrope®, SurePal™, pen device

Published
2013

6. International practice of corticosteroid replacement therapy in congenital adrenal hyperplasia: data from the I-CAH registry

Author

Bacila, I., Freeman, N., Daniel, E., Sandrk, M., Bryce, J., Ali, S.R., Abali, Z. Yavas, Atapattu, N., Bachega, T.A., Balsamo, A., Birkebæk, N., Blankenstein, O., Bonfig, W., Cools, M., Costa, E.C., Darendeliler, F., Einaudi, S., Elsedfy, H.H., Finken, M., Gevers, E., Claahsen-van der Grinten, H.L., Guran, T., Güven, A., Hannema, S.E., Higham, C.E., Iotova, V., Kamp, H.J. van de, Korbonits, M., Krone, R.E., Lichiardopol, C., Luczay, A., Mendonca, B.B., Milenkovic, T., Miranda, M.C., Mohnike, K., Neumann, U., Ortolano, R., Poyrazoglu, S., Thankamony, A., Tomlinson, J.W., Vieites, A., Vries, L. de, Ahmed, S.F., Ross, R.J.M., Krone, N.P., Bacila, I., Freeman, N., Daniel, E., Sandrk, M., Bryce, J., Ali, S.R., Abali, Z. Yavas, Atapattu, N., Bachega, T.A., Balsamo, A., Birkebæk, N., Blankenstein, O., Bonfig, W., Cools, M., Costa, E.C., Darendeliler, F., Einaudi, S., Elsedfy, H.H., Finken, M., Gevers, E., Claahsen-van der Grinten, H.L., Guran, T., Güven, A., Hannema, S.E., Higham, C.E., Iotova, V., Kamp, H.J. van de, Korbonits, M., Krone, R.E., Lichiardopol, C., Luczay, A., Mendonca, B.B., Milenkovic, T., Miranda, M.C., Mohnike, K., Neumann, U., Ortolano, R., Poyrazoglu, S., Thankamony, A., Tomlinson, J.W., Vieites, A., Vries, L. de, Ahmed, S.F., Ross, R.J.M., and Krone, N.P.

Abstract

Contains fulltext : 231533.pdf (Publisher’s version ) (Open Access), OBJECTIVE: Despite published guidelines no unified approach to hormone replacement in congenital adrenal hyperplasia (CAH) exists. We aimed to explore geographical and temporal variations in the treatment with glucocorticoids and mineralocorticoids in CAH. DESIGN: This retrospective multi-center study, including 31 centers (16 countries), analyzed data from the International-CAH Registry. METHODS: Data were collected from 461 patients aged 0-18 years with classic 21-hydroxylase deficiency (54.9% females) under follow-up between 1982 and 2018. Type, dose and timing of glucocorticoid and mineralocorticoid replacement were analyzed from 4174 patient visits. RESULTS: The most frequently used glucocorticoid was hydrocortisone (87.6%). Overall, there were significant differences between age groups with regards to daily hydrocortisone-equivalent dose for body surface, with the lowest dose (median with interquartile range) of 12.0 (10.0-14.5) mg/m2/day at age 1-8 years and the highest dose of 14.0 (11.6-17.4) mg/m2/day at age 12-18 years. Glucocorticoid doses decreased after 2010 in patients 0-8 years (P < 0.001) and remained unchanged in patients aged 8-18 years. Fludrocortisone was used in 92% of patients, with relative doses decreasing with age. A wide variation was observed among countries with regards to all aspects of steroid hormone replacement. CONCLUSIONS: Data from the I-CAH Registry suggests international variations in hormone replacement therapy, with a tendency to treatment with high doses in children.

Published
2021

11. Genotyp-Phänotyp-Korrelationen bei Kindern und Jugendlichen mit nichtklassischem adrenogenitalen Syndrom mit 21-Hydroxylase-Defekt

Author

Dörr, H. G., primary, Schulze, N., additional, Bettendorf, M., additional, Binder, G., additional, Bonfig, W., additional, Denzer, C., additional, Dunstheimer, D., additional, Salzgeber, K., additional, Schmidt, H., additional, Schwab, K. O., additional, Voss, E., additional, Wabitsch, M., additional, and Wölfle, J., additional

Published
2020
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17. Interaction of Pubertal Development and Metabolic Control in Adolescents with Type 1 Diabetes Mellitus

Author

Plamper, M., Gohlke, B., Woelfle, J., Konrad, K., Rohrer, T., Hofer, S., Bonfig, W., Fink, K., Holl, R. W., Plamper, M., Gohlke, B., Woelfle, J., Konrad, K., Rohrer, T., Hofer, S., Bonfig, W., Fink, K., and Holl, R. W.

Abstract

Background. In T1DM, delayed pubertal development and reduced final height are associated with inadequate metabolic control. Objective. To assess whether T1DM affects pubertal growth spurt and whether metabolic control during puberty is gender-related. Methods. Using a large multicentre database, longitudinal data from 1294 patients were analysed. Inclusion criteria: complete records of height and HbA1c from the age of seven to 16 years. Exclusion criteria: other significant chronic diseases and medications, T1DM duration less than three months, and initial BMI < 3rd or > 97th percentile. Results. Growth velocity (GV) was impaired with a significant reduction of peak GV by 1.2 cm in boys. HbA1c increase during male puberty was lower except for a period of 1.5 years. The highest HbA1c increase in boys coincided with maximum growth spurt. In girls, the highest HbA1c increase was observed during late puberty. Even though there is impaired GV, both sexes reach a height at 16 years of age which corresponds to the background population height. Conclusion. Worsening of metabolic control is sex-discordant and associated with gender-specific alterations of GV. However, the vast majority of boys and girls with T1DM seems to reach normal height at the age of 16 years.

Published
2017

19. Effectiveness and Safety of rhIGF-1 Therapy in Children: The European Increlex® Growth Forum Database Experience

Author

Bang, P, Polak, M, Woelfle, J, Houchard, A, Hausler, G, Zwiauer, K, Adiceam, P, Carla Malpuech, H, Cessans, C, Cogne, M, Colle, M, Coutant, R, Houang, M, Lienhardt, A, Mallet, E, Nicolino, M, Petrus, M, Tauber, Mt, Wagner, K, Weill, J, Akkurt, I, Bechtold, S, Bierkamp Christophersen, D, Blanke, Jg, Bonfig, W, Doerr, Hg, Frühwald, M, Hartmann, K, Hauffa, B, Holterhus, Pm, Hübner, A, Ittner, J, Jourdan, C, Keller, A, Kim Berger HS, Köster, B, Krüger, J, Land, C, Leichter, H, Lorenzen, F, Meissner, T, Mohnike, K, Morlot, M, Müller, H, Ockert, C, Rohrer, T, Pankau, R, Partsch, Cj, Schönau, E, Schwab, K, Simic Shleicher, G, Tittel, B, Bernasconi, S, Cannavo', Salvatore, Cappa, M, Cavallo, L, Cherubini, V, Chiumello, G, Citro, G, Concolino, D, Perri, P, Lampis, A, Maghnie, M, Perrone, L, Pilotta, A, Sinisi, A, Zuccotti, G, Zucchini, S, Ben Skowronek, I, Birkholz, D, Bossowski, A, Hilczer, M, Korpal Szczyrska, M, Smyczynska, J, Szewczyk, L, Argente, J, Bezanilla, C, Carrascosa, A, Diaz, R, Fernandez, C, Hermoso, F, Luzuriaga, C, Martos, J, Prieto, P, Sanchez Del Pozo, J, Vela, A, Ekström, K, Nilsson, Nö, Ahmed, F, Denvir, L, Hussain, K, Johnstone, H, Mushtaq, T, Patel, L, Ramakrishnan, R, Rose, S, Shaw, N, Storr, H., Bang, P, Polak, M, Woelfle, J, Houchard, A, EU IGFD Registry Study, Group, and Perrone, Laura

Subjects
Male, Adolescent, Databases, Factual, Endocrinology, Diabetes and Metabolism, MEDLINE, EU IGFD registry, computer.software_genre, Short stature, Endocrinology, rhIGF-1 therapy, Humans, Medicine, Insulin-Like Growth Factor I, Child, Growth Disorders, Database, Height, business.industry, severe primary insulin-like growth factor-1 deficiency, Recombinant Proteins, Europe, short stature, Child, Preschool, Pediatrics, Perinatology and Child Health, Female, Observational study, medicine.symptom, Height, rhIGF-1 therapy, EU IGFD registry, short stature, severe primary insulin-like growth factor-1 deficiency, business, computer
Abstract

Background/Aims: We report data from the EU Increlex® Growth Forum Database (IGFD) Registry, an ongoing, open-label, observational study monitoring clinical practice use of recombinant human insulin-like growth factor-1 (rhIGF-1) therapy in children. Methods: Safety and effectiveness data on rhIGF-1 treatment of 195 enrolled children with growth failure were collected from December 2008 to September 2013. Results: Mean ± SD (95% CI) height velocity during first year of rhIGF-1 treatment was 6.9 ± 2.2 cm/year (6.5; 7.2) (n = 144); in prepubertal patients naïve to treatment, this was 7.3 ± 2.0 cm/year (6.8; 7.7) (n = 81). Female sex, younger age at start of rhIGF-1 therapy, and lower baseline height SDS predicted first-year change in height SDS. The most frequent targeted treatment-emergent adverse events (% patients) were hypoglycemia (17.6%, predictors: young age, diagnosis of Laron syndrome, but not rhIGF-1 dose), lipohypertrophy (10.6%), tonsillar hypertrophy (7.4%), injection site reactions (6.4%), and headache (5.9%). Sixty-one serious adverse events (37 related to rhIGF-1 therapy) were reported in 31 patients (16.5%). Conclusion: Safety and effectiveness data on use of rhIGF-1 in a ‘real-world' setting were similar to those from controlled randomized trials. Severe growth phenotype and early start of rhIGF-1 improved height response and predicted risk of hypoglycemia.

Published
2015

20. Long-term Surveillance of Children with Congenital Hypothyroidism: Data from the German Registry for Congenital Hypothyroidism (AQUAPE Hypo Dok)

Author

Ellerbroek, V. L., Bonfig, W., Doerr, H. -G., Bettendorf, M., Hauffa, B., Fricke-Otto, S., Rohrer, T., Reschke, F., Schoenau, E., Schwab, K. O., Kapelari, K., Roehl, F. -W., Mohnike, K., Holl, R. W., Ellerbroek, V. L., Bonfig, W., Doerr, H. -G., Bettendorf, M., Hauffa, B., Fricke-Otto, S., Rohrer, T., Reschke, F., Schoenau, E., Schwab, K. O., Kapelari, K., Roehl, F. -W., Mohnike, K., and Holl, R. W.

Abstract

Background: The German study group for quality assurance in pediatric endocrinology and the University of Ulm have established a software (Hypo Dok) for the documentation of longitudinal data of patients with congenital primary hypothyroidism (CH). Aim of this study was to analyse the long-term follow-up of patients with CH and to compare treatment with current guidelines. Methods/Patients: Anonymised data of 1 080 patients from 46 centres were statistically analysed. Results: Newborn screening result was available at a mean age of 7.3 days. Confirmation of the diagnosis was established at 8.4 days and therapy was started at 11 days. The average screening TSH was 180.0 mIU/L. During the first 3 months mean levothyroxine (LT4) dose was 10.7 mu g/kg/day or 186.0 mu g/m(2)/day. Weight-, BMI-and height-SDS did not differ significantly from the normal population. Only 25 % of the patients (n = 262) underwent formal EQ/IQ-testing. Their average IQ was 98.8 +/- 13.2 points. Discussion: In Germany screening, confirmation and start of treatment of CH are within the recommended time frame of 14 days. Initial LT4-doses are adequate. The auxological long-term outcome of young CH patients is normal. The implementation of standardized IQ testing has to be improved in routine patient care. Conclusion: Longitudinal data of patients with CH was analysed and compared to current guidelines. Confirmation and start of treatment are - according to the recommendations. However standardised IQ testing requires improvement.

Published
2015

21. Hereditäre Persistenz des Alpha-Fetoproteins

Author

Bauer, F., Bornkamm, M., Götz, C., Teichert Von Lüttichau, I., Liptay, S., Burdach, S., and Bonfig, W.

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Hintergrund: Die hereditäre Persistenz des Alpha-Fetoproteins (AFP) ist eine seltene, autosomal-dominant vererbete, gutartige Entität. Erhöhte AFP-Werte sind in diesem Zusammenhang jedoch schwierig zu interpretieren, wenn auf ein Malignom gescreent wurde und können zu überflüssigen[for full text, please go to the a.m. URL], Süddeutsche Tage der Kinder- und Jugendmedizin; 61. Jahrestagung der Süddeutschen Gesellschaft für Kinder- und Jugendmedizin und der Süddeutschen Gesellschaft für Kinderchirurgie und dem Berufsverband für Kinder- und Jugendärzte – Landesverband Bayern

Published
2012
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22. Erschwerte Differentialdiagnose bei 17jährigem adipösem Patienten: Typ 1 Diabetes? Typ 2 Diabetes? Oder 'Doppel-Diabetes'?

Author

Warncke, K., Ziegler, A.-G., Achenbach, P., Bonfig, W., Burdach, S., and Engelsberger, I.

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Problemstellung: Bei Kindern und Jugendlichen mit Diabetes besteht in 90–95% der Fälle ein Typ 1 Diabetes. Aufgrund der zunehmenden Anzahl an übergewichtigen Kindern und Jugendlichen treten auch in dieser Altersklasse zunehmend Fälle von Typ 2 Diabetes und Mischformen auf.[for full text, please go to the a.m. URL], Süddeutsche Tage der Kinder- und Jugendmedizin; 61. Jahrestagung der Süddeutschen Gesellschaft für Kinder- und Jugendmedizin und der Süddeutschen Gesellschaft für Kinderchirurgie und dem Berufsverband für Kinder- und Jugendärzte – Landesverband Bayern

Published
2012

23. Pseudotumor cerebri - eine Rarität kommt selten allein (Teil I)

Author

Schütz, M., Bonfig, W., Sadowski, B., Steinborn, M., Boerschmann, H., and Makowski, C.

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Fragestellung: Neu aufgetretenes Schielen als Erstsymptom eines Pseudotumor cerebri (PTC) bei einem kleinen Jungen - wann muss im Kindesalter an diese Diagnose gedacht werden? Methodik: Fallbericht eines 3-jährigen Jungen mit idiopathischem PTC. Ergebnis: Als PTC (Syn.: Idiopathische[for full text, please go to the a.m. URL], Süddeutsche Tage der Kinder- und Jugendmedizin; 61. Jahrestagung der Süddeutschen Gesellschaft für Kinder- und Jugendmedizin und der Süddeutschen Gesellschaft für Kinderchirurgie und dem Berufsverband für Kinder- und Jugendärzte – Landesverband Bayern

Published
2012
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24. Panhypopituitarismus nach schwerem Schädel-Hirn-Trauma: Der besondere Fall und seine Konsequenzen für den klinischen Alltag

Author

Breuling, K., Bonfig, W., Krohn, C., and Hosie, S.

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Wir stellen den Fall eines Knaben vor, der nach SHT einen Panhypopituitarismus entwickelt hat. Die daraus folgenden und auf einer Literaturrecherche basierenden Überlegungen zur endokrinologischen Diagnostik bei Patienten mit schwerem SHT werden diskutiert[for full text, please go to the a.m. URL], Süddeutsche Tage der Kinder- und Jugendmedizin; 61. Jahrestagung der Süddeutschen Gesellschaft für Kinder- und Jugendmedizin und der Süddeutschen Gesellschaft für Kinderchirurgie und dem Berufsverband für Kinder- und Jugendärzte – Landesverband Bayern

Published
2012

25. Pseudotumor cerebri – eine Rarität kommt selten allein: Teil II

Author

Michel, J, Kraus, V, Bonfig, W, Steinborn, M, Sadowski, B, and Makowski, C

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Hintergrund: Mädchen mit Pseudotumor cerebri (PTC) unter Therapie mit Wachstumshormon. Fallstricke bei der Diagnosefindung und Outcome 10 Wochen nach Diagnosestellung. Methodik: Retrospektive Betrachtung des Falles einer 11 Jahre alten präpubertären Patientin mit PTC. Ergebnisse:[for full text, please go to the a.m. URL], Süddeutsche Tage der Kinder- und Jugendmedizin; 61. Jahrestagung der Süddeutschen Gesellschaft für Kinder- und Jugendmedizin und der Süddeutschen Gesellschaft für Kinderchirurgie und dem Berufsverband für Kinder- und Jugendärzte – Landesverband Bayern

Published
2012
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26. Eine Selentherapie führt bei Kindern und Jugendlichen mit Autoimmun-Thyreoiditis nicht zu einem signifikanten Absinken der TPO-Antikörper

Author

Bonfig, W and Schmidt, H

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Hintergrund: Bei Erwachsenen mit Autoimmun-Thyreoiditis (AIT) wurde unter Selen-Substitutionstherapie ein signifikantes Absinken der TPO-Antikörper (TPO-AK) beobachtet. Untersuchungen zum Effekt der Selen-Substitution bei Kindern und Jugendlichen mit AIT liegen bisher nicht vor. Fragestellung:[for full text, please go to the a.m. URL], Süddeutsche Tage der Kinder- und Jugendmedizin; 61. Jahrestagung der Süddeutschen Gesellschaft für Kinder- und Jugendmedizin und der Süddeutschen Gesellschaft für Kinderchirurgie und dem Berufsverband für Kinder- und Jugendärzte – Landesverband Bayern

Published
2012
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27. Pseudohypoaldosteronismus Typ 3 (PHA Typ 3) bei obstruktiver Uropathie und Pyelonephritis

Author

Warncke, K, Reploh, T, Demir, I, Dreßel, P, von Harbou, M, Tollens, M, Burdach, S, and Bonfig, W

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Der Pseudohypoaldosteronismus ist eine sehr seltene Erkrankung. Man unterscheidet die kongenitale Form (Typ 1) von der transienten Form (Typ 3), die bei Patienten mit obstruktiver Uropathie oder im Rahmen von infektiösen Nierenerkrankungen auftritt. Die Patienten präsentieren sich unter dem[for full text, please go to the a.m. URL], Süddeutsche Tage der Kinder- und Jugendmedizin; 61. Jahrestagung der Süddeutschen Gesellschaft für Kinder- und Jugendmedizin und der Süddeutschen Gesellschaft für Kinderchirurgie und dem Berufsverband für Kinder- und Jugendärzte – Landesverband Bayern

Published
2012
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29. Long-term Surveillance of Children with Congenital Hypothyroidism: Data from the German Registry for Congenital Hypothyroidism (AQUAPE “Hypo Dok”)

Author

Ellerbroek, V., additional, Bonfig, W., additional, Dörr, H.-G., additional, Bettendorf, M., additional, Hauffa, B., additional, Fricke-Otto, S., additional, Rohrer, T., additional, Reschke, F., additional, Schönau, E., additional, Schwab, K., additional, Kapelari, K., additional, Röhl, F.-W., additional, Mohnike, K., additional, and Holl, R., additional

Published
2015
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33. Hereditäre Persistenz des Alpha-Fetoproteins

Author

Bauer, F, Bornkamm, M, Götz, C, Teichert von Lüttichau, I, Liptay, S, Burdach, S, Bonfig, W, Bauer, F, Bornkamm, M, Götz, C, Teichert von Lüttichau, I, Liptay, S, Burdach, S, and Bonfig, W

Published
2012

36. Scientific World Journal: selenium supplementation does not decrease thyroid peroxidase antibody concentration in children and adolescents with autoimmune thyroiditis

Author

Bonfig, W., Gartner, R., and Schmidt H.

Subjects
Peroxidase -- Health aspects -- Care and treatment, Thyroiditis, Autoimmune -- Care and treatment -- Control, Health
Abstract

In adults, selenium supplementation decreases thyroid peroxidase antibody (TPO Ab) concentrations in patients with autoimmune thyroiditis (AIT). Our aim in this study was to investigate if selenium supplementation decreased TPO [...]

Published
2010

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