NEWS HIGHLIGHTS
Published Studies Related to Serostim (Somatropin)
Cost-effectiveness of somatropin for the treatment of short children born small for gestational age. [2010.06]
BACKGROUND: Short children born small for gestational age (SGA) may be at increased risk for long-term morbidity and reduced health-related quality of life (HRQoL) due to their short stature. Normalization of height in childhood and adolescence is possible in such children via the use of the recombinant human growth hormone somatropin. OBJECTIVE: The aim of this study was to determine whether somatropin was a cost-effective treatment option in short children born SGA... CONCLUSION: In this model, somatropin was a cost-effective treatment option for short children born SGA from the perspective of the UK NHS.
Relative bioavailability of two drug products of somatropin obtained from either the milk of transgenic cows or bacterial culture. [2010]
BACKGROUND: Our objective was to assess the relative bioavailability of the first somatropin produced in transgenic cloned cows that carry the human growth hormone (GH) gene (Biohormon) and somatropin produced in Escherichia coli culture (HHT), the procedure most frequently used for the commercial production of the hormone... CONCLUSION: This study demonstrates that a single dose of Biohormon, the first product with somatropin obtained from milk of transgenic mammals, is bioequivalent to the reference product HHT according to standard criteria. Copyright (c) 2010 S. Karger AG, Basel.
Cost-effectiveness of somatropin for the treatment of short children born small
for gestational age. [2010]
cost-effective treatment option in short children born SGA... CONCLUSION: In this model, somatropin was a cost-effective treatment option for
Effect of the inhaled corticosteroid mometasone on small airway patency in patients with asthma. [2009.05]
The inflammation in asthma involves both the large and the small airways. This study was designed to examine whether mometasone delivered from a dry powder inhaler would improve those parameters thought to reflect patency and obstruction of the small airways (diameter <2 mm)... Mometasone delivered by a dry powder inhaler improved asthma control and pulmonary function in tests reflecting both large and small airways.
Clinical Trials Related to Serostim (Somatropin)
American Norditropin Studies - Registry of Growth Hormone (GH) Patients [Recruiting]
The Norditropin National Registry is a post-marketing registry of patients using Norditropin
therapy.
A large body of data will be generated to meet the following Registry Objectives:
- To develop a pharmacodynamic model defining the relationship of Norditropin dose to IGF
changes, accounting for effects of known or suspected independent variables such as
age, gender and puberty
- To develop a model defining the relationship of GH dose and IGF exposure to treatment
outcomes, accounting for effects of known or suspected independent variables such as
age, gender and puberty
- To develop a safety model that related GH doses to adverse even occurrence, again
accounting for the effects of known or suspected independent variables
- To determine the relative predictive values of pre-treatment GH stimulation tests and
pre-treatment IGF-I and IGFBP-3 levels
Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects [Recruiting]
Convenience and preference for the new Mark VII pen compared to the current Genotropin pen
will be assessed using a questionaire. it is expected that the new pen will be preferred or
at least no different to the current pen.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Pegylated-Somatropin in Healthy Volunteers [Recruiting]
A Study of Zomacton in Children With Growth Hormone Deficiency [Recruiting]
This trial is set up to compare Zomacton to Genotropin for the treatment of growth hormone
deficiency in children. The children will be treated for 1 year. Half of the patients will
be treated with Genotropin and half with Zomacton. During this time they will be dosed every
day by themselves or their parents at home in the evening. There will be 138 patients in the
trial from age 3 to age 11. The patients cannot have been treated before with growth hormone
and the patients must have a proven growth hormone deficiency, this will be shown by a
specific test that will be performed before the trial in the local clinic and once during
the trial. During the time of the treatment the patients will come to visit the clinic every
3 months. At these visits their heights will be measured, blood samples will be taken,
physical examinations will be performed and questions about their health will be asked. At 2
times in the trial they will have a hand x-ray taken to measure the bone age. At the end of
the trial the patients will stop the treatment and continue on one of the marketed products
available to treat growth hormone deficiency.
Effects of Short-term Growth Hormone in HIV-infected Patients [Recruiting]
The purpose of this study is to examine the short-term effects of two different doses of
growth hormone, compared to treatment with growth hormone releasing hormone, on the brain's
secretion of growth hormone and the body's glucose metabolism. We hypothesize that growth
hormone administration will alter the body's endogenous pulsatile growth hormone secretion
and that higher dose growth hormone may decrease insulin sensitivity. We hypothesize that
growth hormone releasing hormone will augment endogenous GH pulsatility and be neutral to
insulin sensitivity.
Reports of Suspected Serostim (Somatropin) Side Effects
Death (3),
Iron Deficiency Anaemia (3),
Malformation Venous (3),
Carpal Tunnel Syndrome (3),
Dieulafoy's Vascular Malformation (3),
Respiratory Failure (3),
Thrombosis (2),
Bone Pain (2),
Pain (2),
Influenza Like Illness (2), more >>
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