"Care of the Growth Hormone Deficient Patient: Transition from Adolescence to Adulthood"

TITLE: "Care of the Growth Hormone Deficient Patient: Transition from Adolescence to Adulthood"

ACKNOWLEDGEMENT OF COMMERCIAL SUPPORT: This activity is supported through an educational grant from Novo Nordisk Inc.

LAST REVIEW DATE: July, 2010

ACTIVITY RELEASE/EXPIRATION DATES: July, 2010 through July, 2011

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"Care of the Growth Hormone Deficient Patient: Transition from Adolescence to Adulthood"

Clinical Dialogue

eCase Challenge

Clinical Dialogues are engaging, video-based roundtable discussions focusing on new guidelines, recent publications, and hot topics in patient management. In tandem with the clinically-focused eCase Challenge, this educational activity creates a complete learning experience.

eCase Challenges are interactive, text-based case studies designed to integrate the educational objectives into day-to-day clinical practice. The video "Clinical Pearl" summarizes key clinical aspects of this activity.

FACULTY

Moderator

Alan D. Rogol, MD, PhD, FAAP, FACSM

Professor of Pediatrics

The James Whitcomb Riley Hospital for Children

Indiana University School of Medicine

Indianapolis, IN

Professor Emeritus

University of Virginia

Charlottesville, VA

Dr. Rogol was born in New Haven, CT and completed his primary and secondary schooling in that area. He received his bachelor's degree in chemistry at MIT and then matriculated to Duke University where he obtained a doctoral degree in Physiology and an MD, both in 1970. Following an internship and residency in pediatrics at the Johns Hopkins Hospital, he did a fellowship in endocrinology at the National Institutes of Health (Clinical Endocrinology Branch).

His first faculty position was as an Assistant Professor at the University of Virginia. Over the next 25 years he became Professor of Pediatrics and Pharmacology at the University of Virginia as well as Chief of the Division of Endocrinology (Pediatrics). In 1999 he became the Chief Scientific Officer for Insmed, Inc in Richmond, Virginia and a part time faculty member of both the University of Virginia and the Medical College of Virginia. He also started a consulting company, ODR Consulting, working mainly with large pharmaceutical companies on the design and safety of clinical trials. In 2008, he joined the part-time (teaching) faculty at the James Whitcomb Riley Hospital for Children in Indianapolis, IN.

He has published more than 250 peer reviewed reports on many subjects in pediatric endocrinology, especially those relating to growth and adolescent development. His interest in the Endocrinology of Sport led to a book on that subject commissioned by the International Olympic committee and he serves as an advisor to the United States Anti-doping Association concerning athletes using endocrine-related substances to attempt to increase athletic performance. For the past 6 years Dr. Rogol has been the Secretary of the Lawson Wilkins Pediatric Endocrine Society, the largest pediatric endocrine society in North America and in June, 2010 became Vice President for Physicians in Practice for The Endocrine Society.

Sara A. DiVall, MD

Assistant Professor of Pediatrics

Johns Hopkins University School of Medicine

Baltimore, MD

Dr. DiVall is a graduate of the University of Wisconsin and received her Medicine degree from the same institution. She completed her Pediatrics residency at Albany Medical College and her Pediatric Endocrinology fellowship at Johns Hopkins University.

After fellowship, Dr. DiVall joined the faculty as Instructor, and was promoted to Assistant Professor two years later. Her research interests involve investigating the molecular mechanisms important in the growth factor regulation of gonadotropin releasing hormone (GnRH) neuronal function at puberty and in obese states, receiving continuous NIH funding for her work. In clinical practice, Dr. DiVall has a special interest in treating and evaluating disorders of puberty and pituitary dysfunction. She has co-authored review articles and book chapters on disorders of growth and pituitary dysfunction.

Mark E. Molitch, MD

Professor of Medicine

Division of Endocrinology, Metabolism, and Molecular Medicine

Northwestern University

Feinberg School of Medicine

Chicago, IL

Dr. Molitch earned an A.B. degree from Princeton University and an M.D. from the University of Pennsylvania. He did his housestaff training at the Hospital of the University of Pennsylvania and an Endocrine Fellowship at the UCLA-Harbor General Hospital in Torrance, California. Prior to joining the faculty at Northwestern in 1984, Dr. Molitch was an Associate Professor at Tufts University School of Medicine in Boston, Massachusetts.

Dr. Molitch has participated in clinical research for many years, focusing on the pathogenesis of pituitary tumors and their treatment. He has participated in the development of most of the medical treatments for prolactinomas and acromegaly. He has also participated in international diabetes trials, including the Diabetes Control and Complications Trial, the Diabetes Prevention Program, and the Bypass Angioplasty Revascularization Investigation 2 Diabetes Trial.

In addition to editing eight books and journal volumes, Dr. Molitch has authored or coauthored more than 350 original papers, review articles, book chapters, case reports and other publications. Dr. Molitch has been an Associate Editor of the Year Book of Endocrinology and is currently an Editor of the journal, Pituitary. In 1997, Dr. Molitch was named "Outstanding Physician Educator in the Field of Diabetes" by the American Diabetes Association. In 2007, he was elected to the Council of The Endocrine Society and he is Chair of the upcoming Endocrine Society Clinical Endocrinology Update 2010.

CME InfoHelp

IN ACCORDANCE WITH ACCME POLICIES, PRIOR TO PARTICIPATING IN THIS ACTIVITY PLEASE REVIEW THE INFORMATION BELOW. YOU MAY LAUNCH THIS PROGRAM AT THE BOTTOM OF THIS PAGE.

"Care of the Growth Hormone Deficient Patient: Transition from Adolescence to Adulthood"

ACCREDITATION STATEMENT

The Endocrine Society is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The Endocrine Society has achieved Accreditation with Commendation. The Endocrine Society designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit.TM Physicians should only claim credit commensurate with the extent of their participation in the activity.

STATEMENT OF INDEPENDENCE

As a provider of continuing medical education (CME) accredited by the Accreditation Council for Continuing Medical Education, The Endocrine Society has a policy of ensuring that the content and quality of this educational activity are balanced, independent, objective, and scientifically rigorous. The scientific content of this activity was developed under the supervision of The Endocrine Society's Special Programs Committee (SPC). The commercial interests of this activity have no influence over the selection of the faculty or specific presentations.

DISCLAIMER

The information presented in this activity represents the opinion of the faculty and is not necessarily the official position of The Endocrine Society.

LEARNING OBJECTIVES

Upon completion of this activity, learners should be better able to:

Recognize the differences in the clinical and diagnostic features of pediatric versus adult growth hormone deficiency cases

Describe the transition of patients from adolescent to adult care

Re-assess Growth Hormone (GH) status in transitional adolescent patients to avoid adverse changes in body composition and bone density

Optimize GH replacement dosing and monitoring in deficient adult patients to minimize cardiovascular risk

Apply GHD guidelines and improve patient outcomes through continued monitoring of patient care

TARGET AUDIENCE

This continuing medical education activity should be of substantial interest to endocrinologists, pediatric endocrinologists and other healthcare professionals involved in the treatment of growth hormone-related endocrine disorders.

DISCLOSURE POLICY

The faculty, committee members, and staff involved in planning this CME activity are required to disclose to learners any relevant financial relationship(s) that have occurred within the last 12 months with any commercial interest(s) whose products or services are discussed in the CME content. Such relationships are defined by remuneration in any amount from the commercial interest(s) in the form of grants; research support; consulting fees; salary; ownership interest (e.g., stocks, stock options, or ownership interest excluding diversified mutual funds); honoraria or other payments for participation in speakers bureaus, advisory boards, or boards of directors; or other financial benefits. The intent of this disclosure is not to prevent faculty with relevant financial relationships from planning or delivery of content, but rather to provide learners with information that allows them to make their own judgments. It remains for learners to determine whether financial interests or relationships may influence the educational activity with regard to exposition or conclusion.

The Endocrine Society has reviewed all disclosures and resolved or managed all identified conflicts of interest, as applicable.

The following faculty reported relevant financial relationships:

Alan D. Rogol, MD, PhD has served as a consultant for Dean Foods, Insmed, Inc., Ipsen, Inc., NovoNordisk, Pfizer, Inc., Solvay, Inc., TEVA Biopharmaceuticals.

Sara A. DiVall, MD has stated she does not have any relevant financial relationships with any commercial interests.

Mark E. Molitch, MD has received research grant support from Eli Lilly and Company.

The following SPC member who planned and/or reviewed content for this activity reported relevant financial relationships:

Gilbert P. August, MD has reported he has no relevant financial relationships and/or conflicts of interest.

Endocrine Society staff associated with the development of this program reported no relevant financial relationships and/or conflicts of interest.

Medical Logix staff associated with the development of content for this activity reported no relevant financial relationships.

POLICY ON UNLABELLED/OFF-LABEL USE

The Endocrine Society has determined that disclosure of unlabeled/off-label or investigational use of commercial product(s) is informative for audiences and therefore requires this information to be disclosed to the learners at the beginning of the presentation.

Uses of specific therapeutic agents, devices, and other products discussed in this educational activity may not be the same as those indicated in product labeling approved by the Food and Drug Administration (FDA). The Endocrine Society requires that any discussions of such off-label use be based on scientific research that conforms to generally accepted standards of experimental design, data collection, and data analysis. Before recommending or prescribing any therapeutic agent or device, learners should review the complete prescribing information, including indications, contraindications, warnings, precautions, and adverse events.

PRIVACY AND CONFIDENTIALITY STATEMENT

The Endocrine Society will record learner's personal information as provided on CME evaluations to allow for issuance and tracking of CME certificates. The Endocrine Society may also track aggregate responses to questions in activities and evaluations and use these data to inform the ongoing evaluation and improvement of its CME program. No individual performance data or any other personal information collected from evaluations will be shared with third parties.

ACKNOWLEDGEMENT OF COMMERCIAL SUPPORT:

This activity is supported through an educational grant from Novo Nordisk Inc.

METHOD OF PARTICIPATION

This enduring material is presented in an online/computer-based format. System requirements include:

Processor Speed: 1.4 GHz P3

Memory: 256 MB RAM (20MB available)

Operating Systems Supported: Windows 2000/XP, MAC

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Connection Speed: 128 Kbps or better

Adobe Acrobat 6.0 or greater

MAC

Processor Speed: G4 processor or higher

Memory: 256 MB RAM

Operating Systems Supported: OSX

Browsers Supported: IE for Mac, Mozilla Firefox and Safari 3.525 or greater

Additional Requirements: Flash player 8.0 or greater

800x600 Resolution or Higher with 32-bit color.

Connection Speed: 128Kbps or better

Adobe Acrobat Reader 6.0 or greater

To receive AMA PRA Category 1 CreditTM, the participant should:

Watch the Clinical Dialogue video and view the slides

Click on the Clinical Dialogue 'Post-Test' button within the player

and/or

Complete the eCase Challenge

Click on the eCase Challenge 'Post-Test' button within the player

Complete the evaluation provided and click on 'submit' to add it to the learner's transcript. The transcript will appear and the learner will have the option of printing a CME certificate then or at a later time, after viewing other CME offerings.

Estimated time to complete this activity: 1.00 hours

PROGRAM OVERVIEW

Defects in the somatotropic (growth hormone/insulin-like growth factor-1) axis lead to some of the most challenging cases that pediatric endocrinologists face. In children, growth hormone deficiency (GHD) and idiopathic short stature (ISS) are two endocrinopathies that result in small size.1 GHD is also associated with unfavorable body composition, worsened bone health, an increase in cardiovascular disease risk and a decreased quality of life for children and adults who suffer from the disorder.2

IGF-I is the primary mediator of growth during infancy and childhood. During infancy, growth and IGF-I levels are initially independent of GH and more closely related to nutrition and insulin secretion. Beyond infancy, childhood growth is more tightly regulated by GH secretion, with the somatotropic axis remaining only partly dependent on insulin and nutritional status.3-4 GH replacement therapy has been used since the 1950s to treat GHD and other causes of short stature 2 in children.

Much investigative focus has been targeted toward unraveling genetic origins for the development and classification of short stature. Mutations in the GH-releasing hormone (GHRH) receptor gene 5, and in the GSα gene can lead to GHRH resistance and thus GHD.6 Several transcription factors critical for normal hypothalamic and pituitary development have been implicated in GHD. Specifically, mutations in early-appearing transcription factors tend to cause multiple pituitary hormone deficiencies (MPHD; e.g. in mutations of HESXI, PROPI, PIT-I, and LHX3/4), whereas others can cause isolated deficiencies (e.g. GHD in Rieger syndrome due to PITX2 mutation).7-8

Among the more exciting ISS data put forth are studies demonstrating mutations and/or deletions of the short stature homeobox-containing gene (SHOX).9 Though the SHOX gene was originally described as the gene responsible for ISS, accumulating evidence underscores the complex correlation between SHOX mutations and/or deletions with human stature. The SHOX gene is of particular interest to those treating children with growth disorders since it has also been linked to Madelung deformity in Leri-Weill syndrome and the short stature component of Turner syndrome 10-11. Growth hormone therapy has been used successfully to treat the short stature of these syndromic patients.11-13 GH therapy has recently been reported to be effective in the treatment of short stature associated with SHOX deficiency in a two-year randomized multi-center trial.13

REFERENCES

Verkauskiene R, Jaquet D, Deghmoun S, Chevenne D, Czernichow P, Levy-Marchal C. 2005. Smallness for gestational age is associated with persistent change in insulin-like growth factor I (IGF-I) and the ratio of IGF-I/IGF-binding protein-3 in adulthood. J Clin Endocrinol Metab. 2005 Oct;90(10):5672-6. Epub 2005 Jul 19.

Molitch ME, Clemmons DR, Malozowski S, Merriam GR, Shalet SM, Vance ML for The Endocrine Society's Clinical Guidelines Subcommittee. Evaluation and treatment of adult growth hormone deficiency: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2006; 91: 1621-1634.

Boguszewski M, Jansson C, Rosberg S, Albertsson-Wikland A 1996 Changes in serum insulin-like growth factor I (IGF-I) and IGF-binding protein-3 levels during growth hormone treatment in prepubertal short children born small for gestational age. J Clin Endocrinol Metab 81:3902 3908.

Johnston LB, Dahlgren J, Leger J, Gelander L, Savage MO, Czernichow P, Wikland KA, Clark AJ 2003 Association between insulin-like growth factor I (IGF-I) polymorphisms, circulating IGF-I, and pre- and postnatal growth in two European small for gestational age populations. J Clin Endocrinol Metab 88:4805 4810.

Wajnrajch MP, Gertner JM, Harbison MD, Chua Jr SC, Leibel RL 1996 Nonsense mutation in the human growth hormone-releasing hormone receptor causes growth failure analogous to the little (lit) mouse. Nat Genet 12: 88 90.

Mantovani G, Maghnie M, Weber G, DeMenis E, Brunelli V, Cappa M, Loli P, Beck-Peccoz P, Spada A 2003 Growth hormone-releasing hormone resistance in pseudohypoparathyroidism type ia: new evidence for imprinting of the Gs gene. J Clin Endocrinol Metab 88:4070 4074.

Cohen LE, Radovick S 2002 Molecular basis of combined pituitary hormone deficiencies. Endocr Rev 23:431 442.

Dattani MT 2005 Growth hormone deficiency and combined pituitary hormone deficiency: does the genotype matter? Clin Endocrinol (Oxf) 63:121 130.

Blaschke RJ, Rappold G. The pseudoautosomal regions, SHOX and disease. Curr Opin Genet Dev. 2006 Jun;16(3):233-9.

Belin V, Cusin V, Viot G, Girlich D, Toutain A, Moncla A, Vekemans M, Le Merrer M, Munnich A, Cormier-Daire V 1998 SHOX mutations in dyschondrosteosis. Nat Genet 19:67 69.

Shears DJ, Vassal HJ, Goodman FR, Palmer RW, Reardon W, Superti-Furga A, Scambler PJ, Winter RM 1998 Mutation and deletion of the pseudoautosomal gene SHOX cause Leri-Weill dyschondrosteosis. Nat Genet 19:70 73.

Sybert VP, Mccauley E. Medical progress Turner's syndrome. N Engl J Med 2004;351:1227 38.

Rosenfeld RG, Attie KM, Frane J, Brasel JA, Burstein S, Cara JF, Chernausek S, Gotlin RW, Kuntze J, Lippe BM, Mahoney CP, Moore WV, Saenger P, Johanson AJ 1998 Growth hormone therapy in Turner's syndrome: beneficial effect on adult height. J Pediatr 132:319 324.

LAST REVIEW DATE: July, 2010

ACTIVITY RELEASE/EXPIRATION DATES: July, 2010 through July, 2011

For technical assistance or information, please contact endocrine@medical-logix.com.

For questions regarding CME content or obtaining CME credit, please contact The Endocrine Society at 301.941.0200 or education@endo-society.org.

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