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Somatotropin

Generic Name
Somatotropin
Brand Names
Genotropin, Humatrope, Norditropin, Norditropin Nordiflex, Nutropin, Nutropinaq, Omnitrope, Saizen, Serostim, Zomacton, Zorbtive, NutropinAq
Drug Type
Biotech
Chemical Formula
-
CAS Number
12629-01-5
Unique Ingredient Identifier
NQX9KB6PCL
Background

Human growth hormone (HGH), also known as somatotropin, is a peptide hormone that is synthesized and secreted by the somatotropic cells of the anterior pituitary gland. Growth hormone plays an essential role in growth regulation during childhood as well as other basal metabolic functions, muscle and fat mass regulation, blood glucose level regulation, and lipid regulation in both children and adults. Synthesized in a strain of Escherichia coli, recombinant HGH is a polypeptide hormone that contains 191 amino acid residues with a molecular weight of 22 kDa. It has an identical primary protein structure to endogenous human growth hormone. Recombinant HGH has been commercially available since 1985 after its development by Genentech. Somatrem was the first available recombinant HGH and was largely replaced by somatropin, another form of recombinant HGH.

Growth hormone therapy is approved for various disorders of growth hormone deficiency, growth failure, or short stature including Turner syndrome, chronic renal insufficiency before transplantation, Prader-Willi syndrome, a history of fetal growth restriction, short stature homeobox (SHOX) haploinsufficiency, Noonan syndrome, idiopathic short stature, and adult- or childhood-onset growth hormone deficiency. Recombinant growth hormone is available as a subcutaneous injection for children and adults under a wide variety of brand names.

Indication

Somatotropin is indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone, short stature associated with Turner syndrome, Prader-Willi syndrome (PWS), idiopathic short stature (ISS), short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency, and short stature born small for gestational age (SGA). It is indicated for the treatment of growth failure in children associated with chronic kidney disease up to the time of renal transplantation.

It is also indicated for adults with adult-onset growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma. It is also used to treat childhood-onset growth hormone deficiency in adults due to congenital, genetic, acquired, or idiopathic causes.

Somatotropin is indicated for the treatment of wasting or cachexia in patients with human immunodeficiency virus (HIV) who are receiving antiretroviral therapy to increase lean body mass and body weight and improve physical endurance.

Somatotropin is indicated for the treatment of short bowel syndrome in adult patients receiving specialized nutritional support.

Associated Conditions
Adult Onset Growth Hormone Deficiency, Cachexia, Childhood-onset Growth Hormone Deficiency, Growth Failure, HIV Wasting Syndrome, Short Bowel Syndrome (SBS), Short Stature
Associated Therapies
-

Effects of Growth Hormone in Chronically Ill Children

Not Applicable
Withdrawn
Conditions
Juvenile Rheumatoid Arthritis
Crohn Disease
HIV Infections
Hurler Syndrome
Cerebral Palsy
First Posted Date
2006-02-03
Last Posted Date
2018-12-14
Lead Sponsor
University of Texas Southwestern Medical Center
Registration Number
NCT00286689
Locations
🇺🇸

Children's Medical Center of Dallas, Dallas, Texas, United States

Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa

Phase 2
Completed
Conditions
Osteoporosis
Anorexia Nervosa
Osteopenia
Eating Disorders
Interventions
Drug: Placebo for Recombinant Human Growth Hormone
Drug: Recombinant Human Growth Hormone
First Posted Date
2006-01-30
Last Posted Date
2020-09-02
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
21
Registration Number
NCT00283595
Locations
🇺🇸

Massachusettes General Hospital, Boston, Massachusetts, United States

Effect of Growth Hormone in Children With Growth Hormone Deficiency

Phase 3
Completed
Conditions
Growth Disorder
Growth Hormone Disorder
Growth Hormone Deficiency in Children
Idiopathic Short Stature
First Posted Date
2005-12-06
Last Posted Date
2017-01-18
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
173
Registration Number
NCT00262249
Locations
🇺🇸

Novo Nordisk Investigational Site, Milwaukee, Wisconsin, United States

Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN®

Phase 4
Completed
Conditions
Growth Hormone Deficiency
Turner Syndrome
Interventions
First Posted Date
2005-11-21
Last Posted Date
2018-06-26
Lead Sponsor
Merck KGaA, Darmstadt, Germany
Target Recruit Count
318
Registration Number
NCT00256126
Locations
🇬🇧

Local Medical Information Office, Feltham, United Kingdom

🇫🇷

Local Medical InformationOffice, Paris, France

Controlled Study to Evaluate the Efficacy and Safety of the Treatment With Growth Hormone in Tibia Fractures

Phase 2
Completed
Conditions
Tibia Fractures
Bone Fracture
First Posted Date
2005-11-16
Last Posted Date
2017-01-23
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
407
Registration Number
NCT00254514
Locations
🇪🇸

Novo Nordisk Investigational Site, Valencia, Spain

An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG

Phase 3
Completed
Conditions
Turner's Syndrome
First Posted Date
2005-11-08
Last Posted Date
2011-05-20
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
27
Registration Number
NCT00250250
Locations
🇨🇿

Faculty Hospital Olomouc, Children's Clinic, Endocrinology Outpatient Department, I.P.Pavlova str. 6,, Olomouc, Czech Republic

🇫🇷

Service de Pédiatrie, Groupe Hospitalier du Havre, 55 bis, rue Gustave Flaubert, Le Havre cedex, France

🇫🇷

Centre d'Endocrinologie Pediatrique, 25 rue Boudet, Bordeaux, France

and more 3 locations

Study to Define Optimal IGF-1 Monitoring in Children Treated With NutropinAq

Phase 3
Completed
Conditions
Dwarfism
Turner Syndrome
Pituitary Diseases
Renal Insufficiency, Chronic
Interventions
First Posted Date
2005-10-07
Last Posted Date
2019-12-09
Lead Sponsor
Ipsen
Target Recruit Count
251
Registration Number
NCT00234533
Locations
🇧🇪

Dienst Kindergeneeskunde, Edegem, Belgium

🇬🇧

University Hospital Wales, Cardiff, Wales, United Kingdom

🇫🇷

Centre Hospitalier General, Le Havre, France

and more 39 locations

Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism

Phase 4
Terminated
Conditions
Hypothyroidism
Interventions
Drug: Growth hormone
Drug: Growth hormone treatment and puberty
First Posted Date
2005-09-21
Last Posted Date
2020-10-30
Lead Sponsor
Baylor College of Medicine
Target Recruit Count
16
Registration Number
NCT00206375
Locations
🇺🇸

Baylor college of Medicine, Houston, Texas, United States

Efficacy and Safety of a High Dosage Compared to the Label Dosage of Somatropin in Early Pubertal Stage Children With Growth Hormone Deficiency

Phase 3
Completed
Conditions
Growth Hormone Deficiency
Interventions
First Posted Date
2005-09-19
Last Posted Date
2009-06-10
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
27
Registration Number
NCT00191165
Locations
🇮🇹

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Verona, Italy

Growth Hormone Treatment in Short Children Born Small for Gestational Age

Phase 3
Completed
Conditions
Infant, Small for Gestational Age
First Posted Date
2005-09-19
Last Posted Date
2007-06-15
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
200
Registration Number
NCT00191529
Locations
🇩🇪

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Koln, Germany

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