Growth Hormone for Short Kids

**Seattle Junk** · 07-30-2005, 11:51 AM

Some may have already read this article. I thought this type of therapy has been used for many years, 20+? The FDA just approved it 2 years ago?

http://pediatrics.about.com/b/a/012301.htm

July 26, 2003
Growth Hormone for Short Kids
____________________________

The Food and Drug Administration (FDA) today approved a new indication for Humatrope (Somatropin, rDNA origin, for injection), a brand of growth hormone, for the long-term treatment of children with idiopathic (of unknown origin) short stature, also called non-growth hormone deficient short stature. "Short stature" has been defined by the American Association of Clinical Endocrinologists and the Growth Hormone Research Society as height more than 2 standard deviations (SD) below the mean for age and sex. This corresponds to the shortest 2.3 percent of children. This new indication restricts therapy to children who are even shorter, specifically more than 2.25 SD below the mean for age and sex, or the shortest 1.2% of children. For example, for 10-year old boys and girls, this would correspond to heights of less than 4' 1" inch. This would further correspond to heights of less than 5' 3" and 4' 11" in adult men and women, respectively.

Today's approval was based on 2 randomized, multicenter trials, conducted in approximately 300 children with idiopathic short stature. The diagnosis of idiopathic short stature was made after excluding other causes of short stature, including growth hormone deficiency.

The pivotal trial was a randomized, double-blind study in 71 children aged 9-15 years. Patients received injections of either Humatrope or placebo three times weekly until adult height was reached. Thirty-three patients contributed final height measurements after a mean treatment duration of 4.4 years. Mean final height of the Humatrope patients exceeded that of the placebo patients by approximately 1.5 inches.

In a second study, patients received one of three increasing doses of Humatrope, in divided doses six times weekly. The average duration of treatment to final height was 6.5 years. Final height exceeded that predicted at the time of enrollment in the majority of patients, and by up to nearly four inches in some. In the high-dose group, mean final height exceeded mean height predicted at baseline by nearly three inches.

The safety profile of Humatrope in children with idiopathic short stature did not differ from that in children with other conditions for which growth hormone is indicated.

Various growth hormone products are currently indicated in children for short stature associated with growth hormone deficiency, chronic renal insufficiency, Turner syndrome, Prader-Willi syndrome, and in children born small for gestational age.

Humatrope's new indication for idiopathic short stature is the first indication for growth hormone in children that specifies a height restriction (see above).

On June 10, 2003, the application for this new indication was presented to FDA's Endocrine and Metabolic Advisory Committee for public discussion and consideration. The advisory committee voted 8-2 in favor of approval.

The manufacturer has advised FDA that it will not engage in direct-to-consumer advertising of Humatrope and will limit the marketing of this product for this new use to pediatric endocrinologists in order to better ensure the proper use of this product in the indicated pediatric population. In addition, the manufacturer intends to tightly control the distribution of Humatrope.

Humatrope is manufactured and distributed by Eli Lilly Co. of Indianapolis, Ind.

***JohnnyB*** · 07-30-2005, 09:49 PM

Originally Posted by Seattle Junk

Some may have already read this article. I thought this type of therapy has been used for many years, 20+? The FDA just approved it 2 years ago?

http://pediatrics.about.com/b/a/012301.htm

July 26, 2003
Growth Hormone for Short Kids
____________________________

The Food and Drug Administration (FDA) today approved a new indication for Humatrope (Somatropin, rDNA origin, for injection), a brand of growth hormone, for the long-term treatment of children with idiopathic (of unknown origin) short stature, also called non-growth hormone deficient short stature. "Short stature" has been defined by the American Association of Clinical Endocrinologists and the Growth Hormone Research Society as height more than 2 standard deviations (SD) below the mean for age and sex. This corresponds to the shortest 2.3 percent of children. This new indication restricts therapy to children who are even shorter, specifically more than 2.25 SD below the mean for age and sex, or the shortest 1.2% of children. For example, for 10-year old boys and girls, this would correspond to heights of less than 4' 1" inch. This would further correspond to heights of less than 5' 3" and 4' 11" in adult men and women, respectively.

Today's approval was based on 2 randomized, multicenter trials, conducted in approximately 300 children with idiopathic short stature. The diagnosis of idiopathic short stature was made after excluding other causes of short stature, including growth hormone deficiency.

The pivotal trial was a randomized, double-blind study in 71 children aged 9-15 years. Patients received injections of either Humatrope or placebo three times weekly until adult height was reached. Thirty-three patients contributed final height measurements after a mean treatment duration of 4.4 years. Mean final height of the Humatrope patients exceeded that of the placebo patients by approximately 1.5 inches.

In a second study, patients received one of three increasing doses of Humatrope, in divided doses six times weekly. The average duration of treatment to final height was 6.5 years. Final height exceeded that predicted at the time of enrollment in the majority of patients, and by up to nearly four inches in some. In the high-dose group, mean final height exceeded mean height predicted at baseline by nearly three inches.

The safety profile of Humatrope in children with idiopathic short stature did not differ from that in children with other conditions for which growth hormone is indicated.

Various growth hormone products are currently indicated in children for short stature associated with growth hormone deficiency, chronic renal insufficiency, Turner syndrome, Prader-Willi syndrome, and in children born small for gestational age.

Humatrope's new indication for idiopathic short stature is the first indication for growth hormone in children that specifies a height restriction (see above).

On June 10, 2003, the application for this new indication was presented to FDA's Endocrine and Metabolic Advisory Committee for public discussion and consideration. The advisory committee voted 8-2 in favor of approval.

The manufacturer has advised FDA that it will not engage in direct-to-consumer advertising of Humatrope and will limit the marketing of this product for this new use to pediatric endocrinologists in order to better ensure the proper use of this product in the indicated pediatric population. In addition, the manufacturer intends to tightly control the distribution of Humatrope.

Humatrope is manufactured and distributed by Eli Lilly Co. of Indianapolis, Ind.

The key words of this article are in bold print. No they have never, to my knowledge used it in 20+ years olds, for height reasons.

JohnnyB

**juicehoe** · 07-31-2005, 11:06 AM

my friend got it about 6-7 years ago to help him grow taller

**Seattle Junk** · 08-01-2005, 02:14 AM

Originally Posted by JohnnyB

The key words of this article are in bold print. No they have never, to my knowledge used it in 20+ years olds, for height reasons.

JohnnyB

Johnny, you misunderstood me bro. I meant they have been using GH for growth in children for 20+ years. Not "20+ year olds". 20+ year olds are not kids, they become adults at 18.

**LAW** · 08-01-2005, 05:20 AM

Originally Posted by juicehoe

my friend got it about 6-7 years ago to help him grow taller

How old was your friend and did it work.
When my son was 8 I took him to a pedatric endocrinologist hoping he would be able to get the GH and she said that he was just going to be short!

My sister,mom and mother in law, are 4'6. This is unusually short and so I wanted to prevent my son from being that short but i couldn't get it. Now it's to late.

**dwaynewade** · 08-01-2005, 06:54 AM

awww... I would get him some anyway...

**juicehoe** · 08-01-2005, 10:46 AM

i think he got it when he was 15. He was shorter then me at the time. Now hes taller then me and im about 5'8. I dont remember much since i didnt know what it was at the time, but he did go to a doctor and had to do a bunch of tests.

Originally Posted by LAW

How old was your friend and did it work.
When my son was 8 I took him to a pedatric endocrinologist hoping he would be able to get the GH and she said that he was just going to be short!

My sister,mom and mother in law, are 4'6. This is unusually short and so I wanted to prevent my son from being that short but i couldn't get it. Now it's to late.

**dr_ma** · 08-03-2005, 05:21 AM

Originally Posted by LAW

How old was your friend and did it work.
When my son was 8 I took him to a pedatric endocrinologist hoping he would be able to get the GH and she said that he was just going to be short!

My sister,mom and mother in law, are 4'6. This is unusually short and so I wanted to prevent my son from being that short but i couldn't get it. Now it's to late.

Doctors suck ass! long live the underground!