104.HGH Therapy for Pediatrics

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104.HGH Therapy for Pediatrics

 

 

 

CATEGORY: Anabolic Steroids 100 Courses

COURSE NUMBER: 104

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Syllabus

Contributors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IX

Preface . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . XV

1 KIGS KIGS: Structure and Organization

Patrick Wilton. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

2 Review Assessment of Growth and Puberty

Gary E. Butler . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

3 KIGS Diagnosis of Children with Short Stature: Insights from KIGS

Kenji Fujieda, Toshiaki Tanaka . . . . .. . . . . . . . . . . . . . . . . . . . . . . 16

4 KIGS Data Analyses within KIGS

Anders Lindberg, Michael B. Ranke . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

5 KIGS The KIGS Aetiology Classification System

Michael B. Rank. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

6 Review Growth Hormone Deficiency: Growth Hormone Tests and

Growth Hormone Measurements

Susan R. Rose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

6 KIGS Growth Hormone Testing in KIGS

Maїthe Tauber. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

7 Review Growth Hormone Deficiency and Modalities of Birth

Angel Ferrandez-Longas, Esteban Mayayo, Jose Ignacio Labarta,

Agustin Romo .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

7 KIGS Modalities and Characteristics at Birth: Commentaries Based on

KIGS Data

Michael B. Ranke . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

8 Review The Role of Insulin-Like Growth Factors in Growth Hormone

Deficiency

Anders Juul. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

8 KIGS Insulin-Like Growth Factor 1 Levels in Patients within the KIGS

Database

Michael B. Ranke . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

9 Review Neuroimaging in Growth Hormone Deficiency

Mohamad Maghnie, Natascia di Iorgi, Andrea Rossi, Roberto Gastaldi,

Paolo Tortori-Donati, Renata Lorini . . . . . . . . . . . . . . . . . . . . . . . . 93

10 Review Characteristics of Idiopathic Growth Hormone Deficiency at

the Start of Growth Hormone Therapy and the Response to Growth

Hormone

Herwig Frisch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108

10 KIGS Idiopathic Growth Hormone Deficiency in KIGS: Selected Aspects

Michael B. Ranke, Edward O. Reiter, David A. Price . . . . . . . . . . . . . . . . . . . 116

11 Review Growth Hormone Deficiency: Puberty and Final Height

Edward O. Reiter, Wayne S. Cutfield . . . . . . .. . . . . . . . . . . . . . . . . . . . 136

11 KIGS Growth Hormone Treatment to Final Height in Idiopathic Growth

Hormone Deficiency: The KIGS Experience

Wayne S. Cutfield , Georgios Karagiannis , Edward O. Reiter . .. . . . . . . . . . . . 145

12 Review The Transition from Childhood to Adulthood: Managing Those with

Growth Hormone Deficiency

Helena Gleeson, Peter E. Clayton . .. . . . . . . . . . . . . . . . . . . . . . . . 163

12 KIGS Effect of Prior Pediatric Growth Hormone Replacement on

Serum Lipids and Quality of Life in Young Adults with Reconfirmed

Severe Growth Hormone Deficiency: The Combined KIGS and

KIMS Experiences

Mitchell E. Geffner, Peter Jonsson, John P. Monson, Roger Abs, Vaclav Hana,

Charlotte Hoybye, Maria Koltowska-Haggstrom .. . . . . . . . . . . 176

13 KIGS Who Stops Growth Hormone in KIGS – and Why?

Michael B. Ranke . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183

14 Review Congenital Growth Hormone Deficiency

Primus E. Mullis . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189

14 KIGS Growth Hormone Deficiency of Known Origin within KIGS

(Code No. 2.1.1–2.1.6)

Michael B. Ranke, Hanna Karlsson . . . . . . . . . . . . . . . . . . . . . . . . 202

15 Review/KIGS Growth Hormone Treatment of Children with Previous

Craniopharyngioma: The KIGS Experience

David A. Price . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207

16 Review/KIGS Growth Hormone Treatment in Rare Disorders: The KIGS Experience

Feyza Darendeliler . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213

17 Review Childhood Brain Tumours and Growth Hormone Treatment

Andreas Jostel, Stephen M. Shalet . . . . . . .. . . . . . . . . . . . . . . . . . . . 240

17 KIGS KIGS Patients with Acquired Growth Hormone Deficiency

(Code No. 2.2 ff.)

Michael B. Ranke . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250

18 KIGS Growth Hormone Treatment of Children with Previous Leukaemia

and Lymphoma: The KIGS Experience

David A. Price, Hanna Karlsson . . . . . . . . . . . . . . . . . . . . . . . . . . . 261

19 Review Growth Hormone, Langerhans Cell Histiocytosis and Neurofibromatosis

Michel Polak . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 269

19 KIGS Growth Hormone Treatment in Neurofibrosis Type 1 Involving

Central Nervous System Tumours and Pituitary Langerhans

Cell Histiocytosis within KIGS

Michael B. Ranke, Wayne S. Cutfield . . . .. . . . . . . . . . . . . . . . . . . 277

20 Review Growth and GH Treatment in Patients with Juvenile Idiopathic

Arthritis

Paul Czernichow . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . 286

20 KIGS The KIGS Experience with Growth Hormone Treatment of

Juvenile Rheumatoid Arthritis

Edward O. Reiter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 292

21 Review Cystic Fibrosis – Growth Hormone Treatment

Dirk Schnabel . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 296

21 KIGS The KIGS Experience with Growth Hormone Treatment of Cystic

Fibrosis

Edward O. Reiter . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 304

22 Review Idiopathic Short Stature: Definition, Spontaneous Growth and

Response to Treatment

Jan M. Wit . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 309

22 KIGS Short- and Long-Term Response to Growth Hormone in Idiopathic

Short Stature: KIGS Analysis of Factors Predicting Growth

Michael B. Ranke, Anders Lindberg, David A. Price, Feyza Darendeliler,

Kerstin Albertsson-Wikland, Patrick Wilton, Edward O. Reiter . . . .  . . . . . . . . 319

23 Review Turner Syndrome – Growth Hormone Treatment

Ron G. Rosenfeld . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . 326

23 KIGS Turner Syndrome within KIGS Including an Analysis of 1146 Patients

Grown to Near Adult Height

Michael B. Ranke, Anders Lindberg . . .. . . . . . . . . . . . . . . . . . . . . 332

24 Review Noonan Syndrome

Christopher J.H. Kelnar . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . 340

24 KIGS Short Stature in Noonan Syndrome: Results of Growth Hormone

Treatment in KIGS

Barto J. Otten, Kees Noordam . . .. . . . . . . . . . . . . . . . . . . . . . 347

25 Review/KIGS Growth Hormone Treatment in Skeletal Dysplasias: The KIGS

Experience

Thomas Hertel . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 356

26 Review Prader-Willi Syndrome and Growth Hormone Treatment

Ann Christin Lindgren . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . 369

26 KIGS Effects of Growth Hormone Treatment in Children Presenting with

Prader-Willi Syndrome: The KIGS Experience

Maithe Tauber . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 377

27 Review Growth and Growth Hormone Treatment in Children Born Small

for Gestational Age and with Silver-Russell Syndrome

Wayne S. Cutfield, Edward O. Reiter on behalf of the KIGS International Board . . . . . 389

27 KIGS KIGS 20 Years: Children Born Small for Gestational Age

David B. Dunger . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 400

28 Review/KIGS Growth Hormone Treatment in Short Children with Chronic

Kidney Disease

Otto Mehls, Anders Lindberg, Richard Nissel, Elke Wuhl, Franz Schaefer,

Burkhard Tonshoff, Dieter Haffner . . . . . . . . . . . . . . . . . . . . . . . . . . . 407

29 Review/KIGS Predicting Growth in Response to Growth Hormone Treatment –

The KIGS Approach

Michael B. Ranke, Anders Lindberg . .. . . . . . . . . . . . . . . . . . . . . 422

30 Review/KIGS Adverse Events Reported in KIGS

Patrick Wilton .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 432

31 Review Progress and Challenges in Understanding the Psychology of

Growth Delay

Brian Stabler, Louis E. Underwood . . .. . . . . . . . . . . . . . . . . . . . . 442

32 Review Growth Hormone and Brain Function

Fred Nyberg . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 450

33 Review Review of Methods for Body Composition Assessment in Children

Jonathan C.K. Wells .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 461

34 Review Metabolic Effects of Growth Hormone

Ulla Feldt-Rasmussen .. . . . . . . . . . . . . . . . . . . . . . . . . . . . 477

35 Review The Growth Plate

Ola Nilsson . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 485

36 Review Pharmacogenetics of Growth Hormone Therapy

Linda B. Johnston, Adrian J.L. Clark . . . . .. . . . . . . . . . . . . . . . . . . . . . 500

Author Index . . . . .. . . . . . . . . . . . . . . . . . . . .  . . . . . . . . . . 509

Subject Index . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 511

 

HGH Therapy for Pediatrics

Growth hormone (GH) was first isolated from cadaver pituitary glands, requiring laborious and expensive collection of glands, followed by extraction and purification of the hormone. This limited supply restricted its use to children with severe GH deficiency who were treated with low dosages and suboptimal schedules. The development of recombinant DNA-derived GH, allowed the production of virtually unlimited amounts of GH, leading to the approval for therapy for a large number of childhood conditions characterized by non-GH deficient short stature. The aim of this review is to provide a critical overview on the daily use of GH in two paradigmatic conditions of non-GH deficient short stature which are children born small for gestational age and with idiopathic short stature, highlighting the available strength of evidence for efficacy and safety.

Reserve it for the GH deficient

 Growth hormone (GH) has been in clinical use for four decades and there has been much rediscovery of wheels in the past 30 years. Childhood growth is GH dependent. Velocity is related to the amplitude of pulsatile GH secretion in an asymptotic manner so that children with very little GH grow very slowly and a small replacement dose has a large effect on growth acceleration. The more GH a child secretes, the more normally he or she grows, the bigger is the dose of GH needed to have a significant effect, but any child given GH in adequate amounts grows more quickly.

To maintain peak concentrations of GH, the pituitary has to increase production as the child grows. This may not happen in some children who then grow poorly in the middle childhood years. When growth is complete and the demand for GH drops, they have ample GH for adult life, which is why most patients do not continue to require treatment. Lack of puberty may give rise to another transient GH insufficient state.

The indication for GH replacement is GH deficiency, congenital or acquired, permanent or transient. GH should be introduced as soon as the failure of its secretion has been identified. The dose is dictated by the clinical situation but there is a tendency to maximise doses at the start of treatment in order to restore lost growth in the least time, with probable long term benefit.

Normal children, children with Turner’s syndrome, renal failure, skeletal dysplasia, etc, all grow more quickly when given GH, but results on adult heights are not all that exciting. This is not surprising as none of the children are GH deficient and GH does nothing for the severity of their underlying conditions. In 50% of patients, predicted height is improved by 5–10 cm. Is this useful?

Short children or adults carry no quantifiable disadvantage and their stature should not be used as an explanation for bullying or being bullied at school, or for losing out in later life. Treatment confers a label and a label carries a stigma. It is important not to stigmatise short people but to accommodate the disadvantage they may perceive and (possibly) help them come to terms with it. The cost of treating two children with GH for one year would buy a clinical psychologist for a year from which more than two patients might well benefit. Children growing at a normal growth velocity should not be treated, regardless of their height.

GH side effects in children have been few, but GH has much of its effect through the generation of insulin like growth factors and insulin itself, and all treated children are in a state of (reversible) hyperinsulinaemic euglycaemia. GH causes water retention, and although treated children rarely become hypertensive, their blood pressure might be higher than it might have been. As GH has a major lipolytic action, the atherogenic soup which GH induces needs to be remembered. There is an association between acromegaly and cancer,7 although extensive studies have not revealed an increased incidence of leukaemia nor relapse from brain tumours in treated children.

I would be chary of encouraging anybody to have hormone replacement if they were not deficient of that hormone. GH is no different. It is negligent not to replace hormones when they are deficient.

Growth Hormone Treatment

At UPMC Children’s Hospital of Pittsburgh, we believe parents and guardians can contribute to the success of this treatment and invite you to participate. Please read the following information to learn about the treatment and how you can help.

Fast Facts About Growth Hormone (GH) Treatment

  • Growth hormone injection treatment is prescribed for children who have been diagnosed with growth hormone (GH) deficiency and other conditions causing short stature.
  • A number of other tests must be conducted first to confirm GH deficiency, Turner Syndrome, or other conditions for which GH therapy is indicated. These tests may include stimulation tests, MRIs, and x-rays. 
  • GH treatment has few side effects.
  • GH treatment is a safe, effective way to treat growth hormone deficiency, Turner Syndrome, and a few other conditions associated with short stature.

How Growth Works

In order for a child to grow, a gland deep inside the brain, called the pituitary, must release enough growth hormone (GH). Natural growth hormone is released during deep sleep. Many factors influence the release of GH, including nutrition, sleep, exercise, stress, medications, blood sugar levels, and other hormones present in the body. 
When a child’s body does not produce or release enough GH, he or she may have several symptoms, the most noticeable being slow or no growth or facial features that make the child look a lot younger than his or her peers. Although being small has no effect on a child’s intelligence, it may cause self-esteem issues and interfere with the development of mature social skills. For that reason, GH treatment may be prescribed to help a child reach his or her fullest growth potential—both in height and in personal development.

How Growth Hormone Treatment Works

Once a child has been diagnosed with GH deficiency, Turner Syndrome, or other conditions treatable with GH therapy, the pediatric endocrinologist will discuss the pros and cons of, and usually recommend, GH therapy. The GH used in treatment is manufactured in the laboratory to be identical to that produced by the pituitary gland, so it is safe and effective. GH is given through a subcutaneous (sub-Q-TAIN-ee-us) injection, which means that it goes into the fatty tissue just beneath the surface of the skin. GH can be given by a special injection device that looks like a pen. Because it is such a shallow injection, the needle is very small and does not hurt much at all.

What To Expect With Growth Hormone Treatment

The main thing to expect is growth! Although it takes about 3 to 6 months to realize any height differences, the important thing is that your child will grow — probably 1 to 2 inches within the first 6 months of starting treatment. There may be a few other things you notice:

  • Your child may outgrow his or her shoes quickly. Foot growth may occur within 6 to 8 weeks, so you may have to buy new shoes more often.
  • Your child may want to eat more. An increase in appetite is common, especially if he or she had a poor appetite before treatment.
  • Your child may look skinnier for a while once height growth starts. An increase in lean body mass and decrease of fat mass are common with GH treatment.

It may take a number of years for your child to reach his or her adult height, so you should be aware that GH treatment is often a long-term commitment. Routine visits with the pediatric endocrinologist will be needed, as will periodic blood tests and x-rays to monitor your child’s progress on the treatment. Although the length of treatment varies, your child probably will have to stay on GH treatment until he or she has:

  • Reached his or her full adult height
  • Reached full bone maturity
  • Grown less than 2 cm in the last year

Getting and Giving GH Injections

GH injections are quick and almost pain-free, so children ages 10 and up may be able to and often prefer to give themselves their own injections. It is important that a parent supervises the injection to make sure the child gives the correct dosage each day. Parents should give the injections to younger children. Because natural growth hormone is released mainly during sleep in children, GH treatment is more effective when taken at bedtime.

Learning how to give GH injections may sound intimidating at first, but once you and your child get used to it, it becomes just another daily habit. There are, however, some tips that you should know when you start GH therapy:

Storage

  • GH must be refrigerated at 36 to 42° F; letting it get too hot or too cold will decrease its effectiveness.
  • If left out overnight, you may place it back into refrigerator and continue to use it. 
  • When traveling, keep it in the cooler provided in the starter kit for up to 10 hours, then put on ice after 10 hours. Be careful not to place GH pens directly in ice — keep them 
    separate by placing pen in a Ziploc bag.

Time of Day

  • Give GH at night, preferably within an hour of sleep. Try to give it consistently within an hour timeframe, for example between 9 and 10 p.m. every night. 
  • You may change the time occasionally, by a few hours earlier or later, but do not give before 5 p.m, except under unusual circumstances (such as leaving for a trip, a sleep-over, etc.)
  • Do not make up missed injections. 
  • For best results, try not to miss more than once per month.

Injection Sites

  • Use 4 of the 8 possible injection sites, and rotate them each time. The sites are back of arms, top or outside of thighs, sides of belly, and outer quadrant of buttocks.
  • Document the site used nightly on a calendar.
  • Document when you open a new cartridge to keep track of expiration dates and how many injections have been used out of each cartridge.

Finishing A Cartridge

Because GH is very expensive, you should use up all of the medication in every cartridge.

  • Pens will only allow you to dial to what is left of the medication. Use up the last of it, and start a new cartridge by doing a second injection with the amount missing.
  • You may have to use up cartridges about once a week or so. If there is less than 0.2 mg left in the old cartridge, or if you are missing less than 0.2 mg of the last injection, do not give an additional injection.

Other Medications

Since GH does not interfere with other medications, it can be taken even if your child is mildly ill (colds, flu), unless your PCP tells you to stop.

  • If your child becomes seriously ill or is hospitalized, call the Endocrinology Clinic for further instructions.

Possible Side Effects

Although infrequent, there are some possible side effects that you should be aware of. They are:

  • Allergic reaction, including swelling at the injection site, rash, or hives
  • Hip, knee, or other joint pain
  • Headache
  • Progression of spine curvature in patients with scoliosis
  • Temporary increase in blood sugar levels, which stops when the GH treatment stops

If the headache is persistent or severe, however, call the Endocrinology Fellow on call immediately. If you have questions about a reaction, or your child is experiencing a reaction, call the Endocrinology Clinic or office.

Insurance Coverage

GH is sold under a number of different prescription brand names, but all of them contain the same medication. Which brand name your child will use, and the shape and color of the pen that delivers the 
medication, will depend upon your medical insurance.  

Because GH is very expensive, Children’s Hospital works with insurance reimbursement specialists to determine which brand will be covered under your medical insurance. Within 2 to 4 weeks after your child has been prescribed HG treatment, an insurance reimbursement specialist will call your home. It is very important that you speak with the specialist — please pick up or return the call! Your child’s prescription will not be filled until you have spoken with the reimbursement specialist. You should receive your child’s GH with 2 to 4 weeks after approval; if you haven’t heard from the reimbursement specialist after 4 weeks, call the Endocrinology Clinic.

If your insurance changes during the course of GH treatment, please notify the Endocrinology Clinic as soon as possible or the continuity of your child’s treatment could be interrupted.

GH Injection Training

As soon as your child’s GH starter kit arrives, call the Endocrinology Clinic to schedule your family’s GH injection training session. Your child and both parents or guardians should attend the training sessions before your child can begin GH treatment. At the training session, the nurse consultant will teach you and your child how to:

  • Care for the medication
  • Recognize the side effects
  • Practice with the demonstration model of your child’s brand of pen and
  • Give a real GH injection

Special Needs and Questions

If you have any questions or if your child has any special needs you feel the Endocrinology Clinic needs to know about, please call the nurse consultant at Children’s Hospital before your child’s clinic appointment.

 

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