ESPE Abstracts

ESPE Abstracts

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Volume 82 | ESPE2014 | Next issue

ESPE 2014

Dublin, Ireland
18 Sep 2014 - 20 Sep 2014

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Dublin, Ireland; 18-20 September 2014. Further information

Poster Presentations

Growth (2)

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Growth (1)
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Perinatal and Neonatal Endocrinology

hrp0082p1-d3-160 | Growth (2) | ESPE2014

Final Height and Safety Outcomes in GH-Treated Children with Short Stature Homeobox-Containing Gene (SHOX) Deficiency: Experience From a Large, Multinational, and Prospective Observational Study

Child Christopher , Quigley Charmian , Zimmermann Alan , Ross Judith , Deal Cheri , Drop Stenvert , Blum Werner

Background: To date, one randomized, controlled, clinical trial (RCCT) demonstrated that GH-treated patients with SHOX deficiency (SHOX-D) had GH-mediated height gain comparable to that of girls with Turner syndrome (TS). No new safety concerns were identified, but the study was limited by small sample size.Objective and hypotheses: To examine long-term outcomes in patients treated in standard clinical practice, we assessed final height (FH) and safety o...
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hrp0082p1-d3-161 | Growth (2) | ESPE2014

Safety and Effectiveness of Increlex® Therapy in Children Enrolled in the Increlex® Growth Forum Database in Europe: 4 Years Interim Results

Polak Michel , Woelfle Joachim , Bang Peter , Sicsic Aude , Fiorentino Bruno

Background: The post-authorization registry, European Increlex® (Mecasermin (rDNA Origin) injection) growth forum database (EU-IGFD) was initiated in Dec 2008 to collect data on children with growth failure treated with Increlex®.Objective: To report 4-year safety and effectiveness data.Methods: Multicenter, open-label observational study, eCRF data collection.Results: As of 30...
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hrp0082p1-d3-162 | Growth (2) | ESPE2014

Infliximab Improves Growth in Paediatric Crohn’s disease Only if Commenced Early in Puberty or Prior to the Onset of Puberty

Gangadharan Arundoss , Metcalf Joanna , Giri Dinesh , Irving Sharon , Auth Marcus , Venkatesh Krishnappa , Krishnamurthy Balaji , Blair Joanne C , Didi Mohammed

Background: Crohn’s disease is a relapsing systemic inflammatory disorder with inflammatory bowel disease (IBD) due to up-regulation of pro-inflammatory cytokines including TNFα. More than 80% of newly diagnosed children present with growth failure Paediatric gastroenterology units in the UK submit data to the UK IBD database which can be accessed when required. One aim of current treatment protocols is to promote growth. Studies on the use of anti-TNFα antibodi...
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hrp0082p1-d3-163 | Growth (2) | ESPE2014

Six Months Follow-Up Pharmacokinetics and Pharmacodynamics Profile of Once-weekly, CTP-modified Human GH (MOD-4023;): phase 2 Dose Finding Study in Children with GHD Deficiency

Hart Gili , Zadik Zvi , Kradziu Klaudziya , Zelinska Nataliya , Malievsky Oleg , Iotova Violeta , Skorodok Julia , Koren Ronit , Amitzi Leanne , Fima Eyal

Background: GH replacement therapy currently requires daily injections, which may cause poor compliance, inconvenience and distress for patients. CTP-modified hGH (MOD-4023) is being developed for once-weekly administration in GH deficient (GHD) children. In the present study the longer term pharmacokinetics (PK) and pharmacodynamics (PD) profile of MOD-4023 in GHD naïve children was assessed.Objective and hypotheses: To assess the long acting prope...
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hrp0082p1-d3-164 | Growth (2) | ESPE2014

Characterization of MOD-4023 Glycosylation, a CTP Modified Long Acting GH in Advanced Clinical Stages

Herskovitz Oren , Moschovich Laura , Guy Rachel , Felikman Yana , Fima Eyal

Background: Prolor Biotech, Inc. is a clinical stage public company developing long acting therapeutic proteins utilizing a technology called CTP. The technology involves fusion of the C-terminus peptide of hCG, which is a highly O-glycosylated peptide, to the target protein. Manufacturing process was developed to generate a reproducible highly glycosylated CTP-modified long-acting hGH (MOD-4023), which supports a single weekly injection in GH deficient patients. MOD-...
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hrp0082p1-d3-165 | Growth (2) | ESPE2014

Validating Genetic Markers of Response to Recombinant Human GH in Children with GH Deficiency or Turner Syndrome: Results From the PREDICT Validation Study

Chatelain Pierre , Stevens Adam , De Leonibus Chiara , Clayton Peter , Wojcik Jerome

Introduction: Genetic markers associated with the response to recombinant human GH (r-hGH) have been identified in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) children in the PREDICT long-term follow-up (LTFU) prospective study (NCT00699855).1 A validation (VAL) study (NCT01419249) was conducted to confirm association.Methods/design: Inclusion criteria for GHD and TS children were identical in the LTFU and VAL studies (GHD defined...
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hrp0082p1-d3-166 | Growth (2) | ESPE2014

Short-Term Changes in Bone Formation Markers Following GH Treatment in Short Prepubertal Children with a Broad Range of GH Secretion

Andersson Bjorn , Swolin-Eide Diana , Magnusson Per , Albertsson-Wikland Kerstin

Background: GH promotes longitudinal growth and bone modeling/remodeling. The bone formation markers intact amino-terminal propeptide of type 1 procollagen (PINP), bone-specific alkaline phosphatase (BALP), and osteocalcin reflect different stages in bone formation, i.e. proliferation with collagen synthesis, matrix maturation, and mineralization.Objective: The purpose was to study the time course of different bone formation markers during GH treatment i...
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hrp0082p1-d3-167 | Growth (2) | ESPE2014

Aromatase Inhibitors in Girls: Anastrazole Combined to an LHRH Analogue is a Safe and Effective Strategy in Girls with Early or Precocious Puberty with Compromised Growth Potential

Papadimitriou Dimitrios T , Dermitzaki Eleni , Papaevangelou Vassiliki , Papadimitriou Anastasios

Background: Third generation aromatase inhibitors have been used to increase predicted adult height (PAH) in boys but in girls only in McCune–Albright syndrome.Objective and hypotheses: We overcame the theoretical concern of secondary hyperandrogenism by combining anastrazole to an LHRH analogue in a 6-year prospective study to test whether the combination therapy could significantly improve PAH compared to inhibition of puberty alone.<p class="...
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hrp0082p1-d3-168 | Growth (2) | ESPE2014

Abstract withdrawn....
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hrp0082p1-d3-169 | Growth (2) | ESPE2014

Recombinant Human GH Therapy Allows to Reach a Normal Final Adult Height in Coeliac Children with GH Deficiency due to Hypophysistis

Iughetti Lorenzo , Lucaccioni Laura , Bruzzi Patrizia , Di Biase Anna Rita , De Bellis Anna Maira , Predieri Barbara

Background: Coeliac disease (CD) can be associated with impaired growth in children after a prolonged period of Gluten-free diet (GFD). A small percentage of CD patients does not show catch-up growth during GFD because of GH secretion deficiency (GHD) that could be associated with antipituitary autoantibodies (APA).Objective and hypotheses: This study aims to evaluate the efficacy of recombinant human GH (rhGH) therapy on final adult height in children w...
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hrp0082p1-d3-170 | Growth (2) | ESPE2014

The ZOMATRIP Study: 4 Year Combination Therapy of GH and GnRHa in Girls with a Short Predicted Adult Height During Early Puberty: Interim Results at the End of the Treatment Phase

Rooman Raoul , France Annick , Heinrichs Claudine , Tenoutasse Sylvie , Brachet Cecile , Cools Martine , De Waele Kathleen , Masa Guy , Lebrethon Marie-Christine , Bourguignon Jean-Pierre , Gies Inge , Van Besien Jesse , De Rycke Christine , De Schepper Jean

Background: A combination of GH and a GnRH agonist is sometimes used to improve adult height in children with a poor height prediction, only few studies support this.Study design: In this multicenter study, 24 short girls in early puberty, with a bone age below 12.0 years, an adult height prediction below 151.0 cm and normal body proportions were treated with GH (Zomacton) transjections 50 μg/kg per day and triptorelin (Decapeptyl) i.m. (3.75 mg/mon...
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hrp0082p1-d3-171 | Growth (2) | ESPE2014

Safety and Efficacy Results of a 6 Month, Randomized, Multi-Center Trial of a Novel Long-Acting rhGH (VRS-317) in Naïve to Treatment, Pre-Pubertal Children with GH Deficiency

Bright George M , Moore Wayne V , Nguyen H Q , Kletter Gad B , Miller Bradley S , Rogers Douglas G , Humphriss Eric , Cleland Jeffrey

Background: VRS-317, a novel fusion protein of rhGH, was safe and well tolerated in single dose studies of adults and children with growth harmone deficiency (GHD).Objectives: Conduct a 6-month study to determine the safety, tolerability, height velocity and IGF1 response in GHD children.Methods: 64 subjects were randomized into three arms to evaluate monthly, semi-monthly and weekly dosing.Results: At VRS-31...
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hrp0082p1-d3-172 | Growth (2) | ESPE2014

Three-Years Height Outcome During rh-GH Therapy in Subjects with Achondroplasia and Hypochondroplasia

Massart Francesco , Vierucci Francesco , Miccoli Mario , Baggiani Angelo

Background: Achondroplasia (ACH) and hypochondroplasia (HCH) are the most common forms of chondrodysplasia. ACH is characterized by rhizomelic short stature, macrocephaly and lumber lordosis. Because HCH is clinically milder, HCH is often goes unrecognized in childhood but is diagnosed in adult life when disproportionate short stature becomes obvious.Objective: Although episodic reports showed the recombinant human GH (rhGH) treatment may improve short-t...
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