... short stature. In clinical trials, vosoritide has shown a positive safety profile and increased height in children with achondroplasia. This article shares the organizational structure, initiation, follow-up protocol, and findings of a vosoritide early access program (EAP) conducted in France. Methods...

... data on long-term safety and final height outcome. Therefore, the aim of this study was to assess the efficacy and safety of bilateral epiphysiodesis to reduce final adult height in tall adolescents. Methods: The study population consisted of 72 patients with extreme tall stature who were followed...

... in GloBE-Reg, a new project that has developed a common registry platform that can support long-term safety and effectiveness studies of drugs. Twelve clinical experts from 7 international endocrine organisations identified by the GloBE-Reg Steering Committee, 2 patient representatives, and representatives...

.... Therefore, this extension study examined the long-term effects of toddler-age GH treatment on height, pubertal development, and safety parameters. Methods: Toddler Turner study participants were invited to enroll in a 10-year observational extension study for annual assessments of growth, pubertal status...

... hormone (GH) treatment in patients with Noonan syndrome (NS). Objective: To evaluate the effectiveness and safety of GH treatment in NS in clinical practice. Methods: Height gain, near-adult height (NAH), and safety were assessed in 2 complementary non-interventional studies: NordiNet® IOS and ANSWER...

.... We assessed height gain and safety in 2,450 children with ISS treated with GH in US clinical practice. Methods: Short-term height gain, near-adult height (NAH), and safety outcomes were investigated using Genetics and Neuroendocrinology of Short Stature International Study data. Results: Compared...

...Roland Pfäffle; Christof Land; Eckhard Schönau; Paul-Martin Holterhus; Judith L. Ross; Carolina Piras de Oliveira; Christopher J. Child; Imane Benabbad; Nan Jia; Heike Jung; Werner F. Blum Background/Aims: To describe characteristics, auxological outcomes and safety in paediatric patients...

...-centre, open-label study to assess the short-term efficacy and safety of this recombinant human growth hormone (r-hGH) preparation for prepubertal children with idiopathic short stature in South Korea. Methods: The SYNERGY study ( ClinicalTrials.gov NCT01746862) was conducted at 9 centres throughout...

...Imane Benabbad; Myriam Rosilio; Christopher J. Child; Jean-Claude Carel; Judith L. Ross; Cheri L. Deal; Stenvert L.S. Drop; Alan G. Zimmermann; Nan Jia; Charmian A. Quigley; Werner F. Blum Background/Aims: To assess auxological and safety data for growth hormone (GH)-treated children with SHOX...

...Delphine Zenaty; Joelle Blumberg; Nilani Liyanage; Evelyne Jacqz-Aigrain; Najiba Lahlou; Jean-Claude Carel; on behalf of co-investigators Background/Aims: To evaluate the efficacy and safety of a triptorelin pamoate (11.25 mg) 3-month formulation in the management of central precocious puberty (CPP...

...Naomi T. Laventhal; Miriam Shuchman; David E. Sandberg In 2010, new data about the safety of recombinant human growth hormone (rhGH) resulted in warnings and subsequent pronouncements by the US Food and Drug Administration (FDA) and its European counterpart [the European Medicines Agency (EMA...

...David B. Allen Recombinant human growth hormone (rhGH) is approved in the United States for treatment of idiopathic short stature (ISS). The occurrence of adverse events (AEs) and the long-term safety of rhGH treatment in this patient population are reviewed. Data were analyzed from postmarketing...

... or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements. Growth hormone Leukaemia Brain...

...Ross G. Clark Recombinant human (rh) insulin-like growth factor I (IGF-I) is being developed as a therapy for short stature caused by IGF deficiency (IGFD) and also for diabetes mellitus. To complement the human efficacy and safety data, a large amount of information is available regarding...

... advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements. Growth hormone Body composition Bone...

... in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred...

.... Post-diagnosis, monitoring of IGF-I and IGFBP-3 levels can be used to assess the efficacy and safety of GH replacement therapy. Furthermore, IGF-I levels, and possibly ALS levels, can be used to aid the diagnosis and monitoring of acromegaly. For example, acromegaly can be excluded in patients...