Cited by 246Growth Hormone and Insulin-like Growth FactorsPituitary Gland Disorders and TreatmentsBiosimilars and Bioanalytical Methods

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Safety of recombinant deoxyribonucleic acid-derived growth hormone: The national cooperative growth study experience

Blethen, S L, Allen, D B, Graves, D, August, G, Moshang, T, Rosenfeld, R·1996·The Journal of Clinical Endocrinology & Metabolism

DOI 10.1210/jcem.81.5.8626820

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Abstract

The National Cooperative Growth Study has monitored the safety of recombinant human GH (rhGH) since 1985. Data have been collected from more than 19,000 children representing over 47,000 patient-years of rhGH treatment. Children receiving GH for renal disease were more likely to develop problems such as intracranial hypertension than those with GH deficiency (P < 0.01). Children with idiopathic short stature were less likely to develop slipped capital femoral epiphysis than those with GH deficiency or Turner's syndrome (P < 0.01). There was no evidence of an increased recurrence of leukemia or central nervous system tumors. There were 3 new cases of leukemia in children without known risk factors for developing leukemia and 5 cases in children with known risk factors. Growth deceleration associated with high affinity, high capacity antibodies to GH was found in only 2 of 5039 subjects tested (0.04%). Major adverse events in association with rhGH treatment have been rare, and preexisting medical conditions such as renal insufficiency may affect their frequency.

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Result
Sermorelin
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Self-citation
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“lence of ICH in our study is in keeping with other studies of rhIGF-1 therapy,(18,20,69) but may be more frequent than reported for rhGH therapy.(70,71)”
Result
Increased Prevalence of Carpal Tunnel Syndrome in Albright Hereditary Osteodystrophy
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Background
DIAGNOSIS AND MANAGEMENT OF GROWTH HORMONE DEFICIENCY IN ADULTS
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Influential
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Background
Orthopedic complications related to growth hormone therapy in a pediatric population
Haidar, R., Nasrallah, M., Der‐Boghossian, A. H., & Ghanem, I. B. (2011) · Journal of Pediatric Orthopaedics B · doi:10.1097/bpb.0b013e32833ed967 · Cited by 21
Endocrine late effects of childhood cancer therapy
Meacham, L. R. (2003) · Current problems in pediatric and adolescent health care · doi:10.1016/s1538-5442(03)00053-1 · Cited by 21
No evidence of tumor growth stimulation in human tumors in vitro following treatment with recombinant human growth hormone
Fiebig, H., Dengler, W. A., & Hendriks, H. R. (2000) · Anti-Cancer Drugs · doi:10.1097/00001813-200009000-00011 · Cited by 21
Growth hormone treatment and risk of malignancy
Chae, H. W., Kim, D., & Kim, H.-S. (2015) · Korean Journal of Pediatrics · doi:10.3345/kjp.2015.58.2.41 · Cited by 20
Intracranial hypertension in pediatric patients treated with recombinant human growth hormone: data from 25 years of the Genentech National Cooperative Growth Study
Noto, R. A., Maneatis, T. J., Frane, J. W., Alexander, K., Lippe, B. M., & Davis, D. A. (2011) · Journal of Pediatric Endocrinology and Metabolism · doi:10.1515/jpem.2011.319 · Cited by 20
Normal and Aberrant Growth in Children
Cooke, D. W., DiVall, S. A., & Radovick, S. (2016) · Elsevier eBooks · doi:10.1016/b978-0-323-29738-7.00024-1 · Cited by 27
Growth hormone therapy
Bajpai, A., & Menon, P. S. N. (2005) · The Indian Journal of Pediatrics · doi:10.1007/bf02760699 · Cited by 21
Consequences of Brand Switches During the Course of Pediatric Growth Hormone Treatment
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Intracranial Hypertension in Cystinosis Is a Challenge: Experience in a Children’s Hospital
Begué, N. M., Alarcón, S., Wolley-Dod, C., et al. (2016) · JIMD Reports · doi:10.1007/8904_2016_18 · Cited by 19
Role of Gorwth Hormone in Ovarian Physiology and Onest of Puberty
Sharara, F. I., & Giudice, L. C. (1997) · Journal of the Society for Gynecologic Investigation · doi:10.1016/s1071-5576(96)00059-7 · Cited by 18
Recombinant Human Growth Hormone
Benedini, S., Terruzzi, I. M., Lazzarin, A., & Luzi, L. (2008) · BioDrugs · doi:10.2165/00063030-200822020-00003 · Cited by 18
“balanced against the known increased morbidity/mortality of untreated GHD (table I).[86-88]”
Diabetic Ketoacidosis Secondary to Growth Hormone Treatment in a Boy with Prader-Willi Syndrome and Steatohepatitis
Yiğit, Ş., Estrada, E., Bucci, K., et al. (2004) · Journal of Pediatric Endocrinology and Metabolism · doi:10.1515/jpem.2004.17.3.361 · Cited by 18
Leukemia in Children Treated with Growth Hormone
Blethen, S. L. (1998) · Trends in Endocrinology and Metabolism · doi:10.1016/s1043-2760(98)00091-5 · Cited by 18
Self-citation
Growth Hormone and Neurofibromatosis
Howell, S. J., Wilton, P., Lindberg, A., & Shalet, S. M. (2000) · Hormone Research in Paediatrics · doi:10.1159/000053208 · Cited by 17
Growth and Growth Disorders
Ergun-Longmire, B., & Wajnrajch, M. P. (2013) · Europe PMC (PubMed Central) · Cited by 17
A Risk-Benefit Assessment of Growth Hormone Use in Children
Blethen, S. L., & MacGillivray, M. H. (1997) · Drug Safety · doi:10.2165/00002018-199717050-00003 · Cited by 18
Self-citation
Off-Label Use of Recombinant IGF-I to Promote Growth: Is It Appropriate?
Rosenbloom, A. L., & Rivkees, S. A. (2010) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2009-2450 · Cited by 16
Growth Hormone Therapy in Children
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Authors: Blethen, S. L., Allen, D. B., Graves, D., August, G., Moshang, T., & Rosenfeld, R.
Affiliations: State University of New York (US)
ORCID: Blethen, S L
Allen, D B
Graves, D
Rosenfeld, R
Venue: The Journal of Clinical Endocrinology & Metabolism
Publisher: The Endocrine Society
Published: 1996-05
Volume: 81
Issue: 5
Pages: 1704-1710
ISSN: 0021-972X (ISSN-L)
1945-7197
DOI: 10.1210/jcem.81.5.8626820
OpenAlex: W2090173071
Cited by: 246
References: 0
Citations by year: 2025: 1 · 2024: 4 · 2023: 2 · 2022: 2 · 2021: 1 · 2020: 54 · 2019: 1 · 2018: 5 · 2017: 4 · 2016: 4 · 2015: 8 · 2014: 5 · 2013: 4 · 2012: 5
FWCI: 10.44
Type: journal article
Language: en
Open access: closed
Locations: The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Growth Hormone and Insulin-like Growth Factors
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Pituitary Gland Disorders and Treatments
Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
Keywords: recombinant human growth hormone, drug safety, growth hormone deficiency, idiopathic short stature, Turner syndrome, kidney disease, intracranial hypertension, slipped capital femoral epiphysis, leukemia recurrence, central nervous system tumors, anti-growth hormone antibodies, growth slowdown, adverse events
MeSH terms: Adolescent, Adult, Carpal Tunnel Syndrome, Child, Edema, Female, Gynecomastia, Humans, Leukemia, Lymphedema, Male, Neoplasms, Nevus, Pseudotumor Cerebri, Recombinant Proteins, Recurrence, Growth Hormone

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Safety of recombinant deoxyribonucleic acid-derived growth hormone: The national cooperative growth study experience

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