8 results on '"Child, Christopher J."'
Search Results
2. Safety Outcomes During Pediatric GH Therapy: Final Results From the Prospective GeNeSIS Observational Program
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Child, Christopher J, Zimmermann, Alan G, Chrousos, George P, Cummings, Elisabeth, Deal, Cheri L, Hasegawa, Tomonobu, Jia, Nan, Lawrence, Sarah, Linglart, Agnès, Loche, Sandro, Maghnie, Mohamad, Pérez Sánchez, Jacobo, Polak, Michel, Predieri, Barbara, Richter-Unruh, Annette, Rosenfeld, Ron G, Yeste Fernández, Diego, Yorifuji, Tohru, Blum, Werner F, and Universitat Autònoma de Barcelona more...
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Male ,medicine.medical_specialty ,Pediatrics ,Diabetes risk ,Adolescent ,Endocrinology, Diabetes and Metabolism ,Clinical Biochemistry ,Population ,030209 endocrinology & metabolism ,Biochemistry ,Short stature ,03 medical and health sciences ,0302 clinical medicine ,Endocrinology ,Risk Factors ,Neoplasms ,Internal medicine ,Turner syndrome ,medicine ,Humans ,Prospective Studies ,Child ,education ,Prospective cohort study ,Growth Disorders ,Clinical Research Articles ,Cerebral Hemorrhage ,education.field_of_study ,Human Growth Hormone ,business.industry ,Incidence ,Incidence (epidemiology) ,Biochemistry (medical) ,medicine.disease ,Recombinant Proteins ,3. Good health ,Idiopathic short stature ,Growth, Growth Hormone, and Growth Factors ,Standardized mortality ratio ,Diabetes Mellitus, Type 2 ,Child, Preschool ,Female ,medicine.symptom ,business ,030217 neurology & neurosurgery ,Follow-Up Studies - Abstract
Context Safety concerns have been raised regarding premature mortality, diabetes, neoplasia, and cerebrovascular disease in association with GH therapy. Objective To assess incidence of key safety outcomes. Design Prospective, multinational, observational study (1999 to 2015). Setting A total of 22,311 GH-treated children from 827 investigative sites in 30 countries. Patients Children with growth disorders. Interventions GH treatment. Main outcome measures Standardized mortality ratio (SMR) and standardized incidence ratio (SIR) with 95% CIs for mortality, diabetes, and primary cancer using general population registries. Results Predominant short stature diagnoses were GH deficiency (63%), idiopathic short stature (13%), and Turner syndrome (8%), with mean ± SD follow-up of 4.2 ± 3.2 years (∼92,000 person-years [PY]). Forty-two deaths occurred in patients with follow-up, with an SMR (95% CI) of 0.61 (0.44, 0.82); the SMR was elevated for patients with cancer-related organic GH deficiency [5.87 (3.21, 9.85)]. Based on 18 cases, type 2 diabetes mellitus (T2DM) risk was elevated [SIR: 3.77 (2.24, 5.96)], but 72% had risk factors. In patients without cancer history, 14 primary cancers were observed [SIR: 0.71 (0.39, 1.20)]. Second neoplasms occurred in 31 of 622 cancer survivors [5.0%; 10.7 (7.5, 15.2) cases/1000 PY] and intracranial tumor recurrences in 67 of 823 tumor survivors [8.1%; 16.9 (13.3, 21.5) cases/1000 PY]. All three hemorrhagic stroke cases had risk factors. Conclusions GeNeSIS (Genetics and Neuroendocrinology of Short Stature International Study) data support the favorable safety profile of pediatric GH treatment. Overall risk of death or primary cancer was not elevated in GH-treated children, and no hemorrhagic strokes occurred in patients without risk factors. T2DM incidence was elevated compared with the general population, but most cases had diabetes risk factors., Safety of GH therapy was assessed in a pediatric observational study. Death and primary cancer rates were not higher than in the general population; T2DM rate was higher owing to risk factors. more...
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- 2018
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Catalog
3. Effect of growth hormone(GH)treatment on adult height in patients with GH deficiency:the Japanese cohort from the GeNeSIS observational study.
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Toshiaki Tanaka, Tomonobu Hasegawa, Keiichi Ozono, Hiroyuki Tanaka, Susumu Kanzaki, Susumu Yokoya, Kazuo Chihara, Tomonori Oura, Katsuichiro Ihara, Child, Christopher J., and Yoshiki Seino
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SOMATOTROPIN ,PITUITARY dwarfism ,NEUROENDOCRINOLOGY ,DESCRIPTIVE statistics ,SCIENTIFIC observation - Abstract
This study evaluated the effect of growth hormone (GH) treatment on adult height in pediatric patients with growth hormone deficiency (GHD) using data from the Japanese cohort of the multinational observational Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS, NCT01088412). We assessed pediatric patients with GHD who received GH therapy and attained adult height, defined as chronological age ≥12 years in girls and ≥14 years in boys and ≥1 of the following: closed epiphyses, height velocity <2 cm/year, or a bone age ≥14 years in girls and ≥16 years in boys. Descriptive statistics for endpoints by gender were calculated using the standards in 2000 for growth chart in Japan. Subgroup analyses were conducted for starting age of GH treatment, concomitant therapy, and mean GH treatment dose. Of the 2001 Japanese children with GHD, there were 230(boys=130;girls=100)who achieved adult height during the study. The mean(±standard deviation [SD])adult height was 159.6±5.4 cm in boys and 146.6±5.7 cm in girls. The change in height standard deviation score was 0.92±0.85 and 0.99±0.91 in boys and girls, respectively. In the subgroup analysis by concomitant therapy, a significant difference(p<0.05)was observed in adult height between boys with and without anabolic steroid hormone use (off—label use). An analysis of adult height by GH treatment dose and by age showed no statistically significant differences. In conclusion, GH—treated Japanese children with GHD exhibited clear improvement in adult height gain. [ABSTRACT FROM AUTHOR] more...
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- 2020
4. Growth Hormone Treatment for Short Stature in the USA, Germany and France: 15 Years of Surveillance in the Genetics and Neuroendocrinology of Short-Stature International Study (GeNeSIS).
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Pfäffle, Roland, Land, Christof, Schönau, Eckhard, Holterhus, Paul-Martin, Ross, Judith L., Piras de Oliveira, Carolina, Child, Christopher J., Benabbad, Imane, Jia, Nan, Jung, Heike, and Blum, Werner F. more...
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SOMATOTROPIN ,NEUROENDOCRINOLOGY - Abstract
Background/Aims: To describe characteristics, auxological outcomes and safety in paediatric patients with growth disorders treated with growth hormone (GH), for cohorts from the USA, Germany and France enrolled in GeNeSIS, a post-authorisation surveillance programme. Methods: Diagnosis and biochemical measurement data were based on reporting from, and GH treatment was initiated at the discretion of, treating physicians. Auxological outcomes during the first 4 years of GH treatment and at near-adult height (NAH) were analysed. Serious and treatment-emergent adverse events were described. Results: Children in the USA (n = 9,810), Germany (n = 2,682) and France (n = 1,667) received GH (dose varied between countries), most commonly for GH deficiency. Across diagnostic groups and countries, mean height velocity standard deviation score (SDS) was > 0 and height SDS increased from baseline during the first 4 years of treatment, with greatest improvements during year 1. Most children achieved NAH within the normal range (height SDS >−2). No new or unexpected safety concerns were noted. Conclusion: GH treatment improved growth indices to a similar extent for patients in all three countries despite variations in GH doses. Data from these three countries, which together contributed > 60% of patients to GeNeSIS, indicated no new safety signals and the benefit-risk profile of GH remains unchanged. [ABSTRACT FROM AUTHOR] more...
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- 2018
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5. Growth hormone treatment of Canadian children: results from the GeNeSIS phase IV prospective observational study.
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Deal, Cheri, Kirsch, Susan, Chanoine, Jean-Pierre, Lawrence, Sarah, Cummings, Elizabeth, Rosolowsky, Elizabeth T., Marks, Seth D., Jia, Nan, and Child, Christopher J.
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SOMATOTROPIN ,PITUITARY dwarfism ,HUMAN growth hormone ,SHORT stature ,GROWTH of children - Abstract
Background: Country-specific data on outcomes of treatment with recombinant human growth hormone are lacking. We present such data for children treated with growth hormone in Canada. Methods: We describe characteristics and outcomes of 850 children (mean age at baseline 8.5 yr) treated with growth hormone constituting the Canadian cohort of the multinational phase IV prospective observational Genetics and Neuroendocrinology of Shortstature International Study (GeNeSIS). The diagnosis associated with short stature was as determined by the investigator. Auxological data were evaluated yearly until near-adult height. Adverse events were assessed in all growth-hormone-treated patients. Results: The diagnosis ascribed as the cause of short stature was growth hormone deficiency in 526 children (61.9%), predominantly organic rather than idiopathic, particularly congenital pituitary abnormalities and intracranial tumours. All diagnostic groups with sufficient patients for analysis had increased height velocity standard deviation score (SDS) and height SDS during growth hormone treatment. For patients who reached near-adult height (n = 293), the mean height SDS was within the normal range for about 80% of patients with organic growth hormone deficiency (n = 131) or idiopathic growth hormone deficiency (n = 50), 50% of patients with idiopathic short stature (n = 10) and 46% of patients with Turner syndrome (n = 79). Eleven deaths were reported, 7 in patients with organic growth hormone deficiency. Serious adverse events considered related to growth hormone treatment (n = 19) were isolated except for medulloblastoma recurrence (n = 2) and adenoidal hypertrophy (n = 2). Interpretation: Growth hormone treatment was effective and had a good safety profile in Canadian children. Growth hormone dosages were lower than in the US and global GeNeSIS cohorts, and a greater proportion of treated Canadian children had organic growth hormone deficiency. Study registration: ClinicalTrials.gov, no. NCT01088412. [ABSTRACT FROM AUTHOR] more...
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- 2018
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6. Incidence of diabetes mellitus and neoplasia in Japanese short-statured children treated with growth hormone in the Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS).
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Susumu Yokoya, Tomonobu Hasegawa, Keiichi Ozono, Hiroyuki Tanaka, Susumu Kanzaki, Toshiaki Tanaka, Kazuo Chihara, Jia, Nan, Child, Christopher J., Katsuichiro Ihara, Jumpei Funai, Noriyuki Iwamoto, and Yoshiki Seino more...
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DIABETES ,LACTIC acidosis ,CANCER ,INSULIN ,ENCEPHALOMYELITIS - Abstract
The primary goal of the Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS) was to assess the safety and effectiveness of Humatrope®, a GH preparation, in the treatment of pediatric patients with short stature. We report our findings in the GH-treated Japanese pediatric population focusing on the incidence of type 2 diabetes (T2D) and occurrence of neoplasms. A total of 2,345 Japanese patients were assessed for safety. During a mean observation period of 3.2 yr, T2D occurred in 3 patients (0.13%) and slowly progressive insulin-dependent diabetes mellitus (SPIDDM) related to underlying mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes (MELAS) in 1 patient (0.04%). Neoplasms were reported in 13 patients (0.56%), including 1 patient with brain tumor (germinoma) and 5 with craniopharyngiomas (4 recurrences); the remainder were benign, typically dermatological, neoplasms. The incidence of diabetes mellitus determined in the study did not differ from previous reports in GH-treated pediatric patients, and there was no apparent increase in the risk of new neoplastic lesions or malignant tumors. [ABSTRACT FROM AUTHOR] more...
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- 2017
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7. Safety Outcomes and Near-Adult Height Gain of Growth Hormone-Treated Children with SHOX Deficiency: Data from an Observational Study and a Clinical Trial.
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Benabbad, Imane, Rosilio, Myriam, Child, Christopher J., Carel, Jean-Claude, Ross, Judith L., Deal, Cheri L., Drop, Stenvert L.S., Zimmermann, alan G., Jia, Nan, Quigley, Charmian a., and Blum, Werner F. more...
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SOMATOTROPIN ,CONFIDENCE intervals ,STANDARD deviations - Abstract
Background/Aims: To assess auxological and safety data for growth hormone (GH)-treated children with SHOX deficiency. Methods: Data were examined for GH-treated SHOX-deficient children ( n = 521) from the observational Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS). For patients with near-adult height information, GeNeSIS results ( n = 90) were compared with a clinical trial ( n = 28) of SHOX-deficient patients. Near-adult height was expressed as standard deviation score (SDS) for chronological age, potentially increasing the observed effect of treatment. Results: Most SHOX-deficient patients in GeNeSIS had diagnoses of Leri-Weill syndrome ( n = 292) or non-syndromic short stature ( n = 228). For GeNeSIS patients with near-adult height data, mean age at GH treatment start was 11.0 years, treatment duration 4.4 years, and height SDS gain 0.83 (95% confidence interval 0.49-1.17). Respective ages, GH treatment durations and height SDS gains for GeNeSIS patients prepubertal at baseline ( n = 42) were 9.2 years, 6.0 years and 1.19 (0.76-1.62), and for the clinical trial cohort they were 9.2 years, 6.0 years and 1.25 (0.92-1.58). No new GH-related safety concerns were identified. Conclusion: Patients with SHOX deficiency who had started GH treatment before puberty in routine clinical practice had a similar height gain to that of patients in the clinical trial on which approval for the indication was based, with no new safety concerns. [ABSTRACT FROM AUTHOR] more...
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- 2017
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8. Radiological Features in Patients with Short Stature Homeobox-Containing (SHOX) GeneDeficiency and Turner Syndrome before and after 2 Years of GH Treatment.
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Child, Christopher J., Kalifa, Gabriel, Jones, Christine, Ross, Judith L., Rappold, Gudrun a., Quigley, Charmian a., Zimmermann, alan G., Garding, Gina, Cutler Jr., Gordon B., and Blum, Werner F.
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TURNER'S syndrome , *HOMEOBOX genes , *SHORT stature , *JUVENILE diseases , *PEDIATRIC research - Abstract
Background/Aims: The short stature homeobox-containing (SHOX) gene is one of many genes that regulate longitudinal growth. The SHOX deficiency (SHOX-D) phenotype, caused by intragenic or regulatory region defects, ranges from normal stature to mesomelic skeletal dysplasia. We investigated differences in radiological anomalies between patients with SHOX-D and Turner syndrome (TS) and the effect of 2 years of growth hormone (GH) treatment on these anomalies. Methods: Left hand/wrist, forearm and lower leg radiographs were assessed at baseline and after 2 years in children with genetically confirmed SHOX-D (GH-treated and untreated groups) and TS (GH-treated) in a randomised, controlled, multinational study. Results: Radiological anomalies of hand, wrist and forearm were common in SHOX-D and TS. Radial bowing appeared more prevalent in SHOX-D, while lower leg anomalies were more common in TS. There were no significant differences in radiological findings between GH-treated and untreated patients with SHOX-D after 2 years. Conclusion: GH treatment had no systematic effect on skeletal findings in SHOX-D, based on limited radiological differences between the GH-treated and untreated groups at 2 years. Bone age radiographs allow assessment of radiological signs indicating a potential diagnosis of SHOX-D and may lead to earlier genetic confirmation and initiation of GH therapy. © 2015 S. Karger AG, Basel [ABSTRACT FROM AUTHOR] more...
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- 2015
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