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16th GRS Workshop

The GH Research Society held its 16th Workshop on the topic of Safety of GH Treatment in Cancer and Intracranial Tumor Survivors in Children and Adults.

This invitation-only workshop was performed through a web-based platform. We had adapted the schedule of this web-based structure with short online meetings taking place on three different occasions last year (June 9th and 16th, and September 29th). The workshop was organized with the support of the European Society of Endocrinology. Other major endocrine societies had also been invited to nominate delegates to the workshop.

Additionally, representatives from the regulatory agencies, EMA and FDA, attended. A review paper on the topic had been written by members of the program organizing committee, and it was distributed to the delegates prior to the start of the meeting. The format of each workshop had been modified over the years, but the backbone of plenary lectures set the scene followed by breakout group discussions of more specific themes or questions.

The final session was devoted to drafting a statement summarizing the outcome of the workshop that was submitted for publication. GRS had published the results of its previous 15 workshops that had ‘stood the test of time’.

Human Growth Homone Indications

FDA approved uses of GH according to the DEA and updated in Aug 2009

In children hGH is approved for the treatment of poor growth due to Turner’s syndrome, Prader-Willi syndrome, and chronic renal insufficiency, hGH insufficiency/deficiency, for children born small for gestational age, and for idiopathic short stature. Accepted medical uses in adults include but are not limited to the treatment of the wasting syndrome of HIV/AIDS and hGH deficiency.

Updated Guidelines for GH Therapy 2003

In August 1996, the FDA approved GH for use in adult patients with GHD. The only approved indication was pituitary disease from known causes, including pituitary tumor, pituitary surgical damage, hypothalamic disease, irradiation, trauma, and reconfirmed childhood GHD. Most patients considered for GH therapy are in one of these categories. A few patients with definite GHD, however, have other kinds of pituitary-hypothalamic disease; these include patients with Sheehan’s syndrome, autoimmune hypophysitis, or hypophysitis associated with other inflammatory conditions, such as sarcoidosis..."

The US FDA has approved GH for use in the following pediatric conditions:
• Growth hormone deficiency
• Turner syndrome
• Chronic renal insufficiency
• Small for gestational age or intrauterine growth retardation
• Prader-Willi syndrome
• Continued height deficit at puberty."

New indications for GH 2005 has a table summarizing the use of growth hormone (GH) therapy in short stature both in the US and Europe:

Treatment recommended by NICE (National Institute for Clinical Excellence) guidelines 2002 in the UK
• GH deficiency, isolated or as part of multiple pituitary hormone deficiency
• Turner syndrome
• Prader Willi syndrome
• Short stature associated with chronic renal failure

Licensed indications in Europe
• GH deficiency, isolated or as part of multiple pituitary hormone deficiency
• Turner syndrome
• Prader Willi syndrome
• Short stature associated with chronic renal failure
• Short stature associated with low birth weight

Licensed in the USA, but not in Europe
• Idiopathic short stature
Short stature conditions where there have been trials of treatment with GH but outcome is not clear (not licensed indications)
• Noonan syndrome
• Skeletal dysplasia
• Rheumatoid arthritis
• Down syndrome
• Short stature associated with prolonged steroid use
• Aarskog’s syndrome





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hGH Indications



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