NEWS HIGHLIGHTS
Published Studies Related to Genotropin (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.
Bioequivalence between novel ready-to-use liquid formulations of the recombinant human GH Omnitrope and the original lyophilized formulations for reconstitution of Omnitrope and Genotropin. [2010.06]
OBJECTIVE: Two strengths of a novel ready-to-use liquid preparation of the recombinant human GH (rhGH) Omnitrope were developed to increase the convenience for the patients. DESIGN: Omnitrope 3.3 mg/ml solution or Omnitrope 6.7 mg/ml solution was compared to Omnitrope 5 mg/ml powder and Genotropin 5 mg/ml powder in terms of pharmacokinetics, pharmacodynamics, safety, and local tolerance after a single s.c. dose of 5 mg... CONCLUSIONS: Omnitrope 3.3 mg/ml solution, 6.7 mg/ml solution, and 5 mg/ml powder, and Genotropin 5 mg/ml powder are bioequivalent, have similar pharmacokinetic and pharmacodynamic profiles, and are equally safe. Overall, the products can be considered to be therapeutically interchangeable.
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
Bioequivalence between novel ready-to-use liquid formulations of the recombinant
human GH Omnitrope and the original lyophilized formulations for reconstitution
of Omnitrope and Genotropin. [2010]
s.c. dose of 5 mg... CONCLUSIONS: Omnitrope 3.3 mg/ml solution, 6.7 mg/ml solution, and 5 mg/ml
Clinical Trials Related to Genotropin (Somatropin)
Extension Study on Safety of Long-Term Growth Hormone Replacement in Adult Patients With Growth Hormone Deficiency [Completed]
To evaluate long-term safety of growth hormone replacement in adult patients with growth
hormone deficiency
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.
Efficacy of Growth Hormone Replacement Therapy in Patients With Chronic Heart Failure and Coexisting Growth Hormone Deficiency [Completed]
Aim of this study is to define the possible benefits of growth hormone supplementation, in
patients with heart failure due to left ventricular systolic dysfunction and coexisting
growth hormone deficiency.
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
Growth Hormone Administration and Its Effects on Cardiovascular Risk Factors in Growth Hormone Deficient Women [Completed]
The purpose of the study is to evaluate the effects of growth hormone replacement on women
with growth hormone deficiency. Growth hormone deficiency means the body no longer produces
growth hormone due to a tumor or some kind of disease of the brain in an area called the
pituitary/hypothalamic region. This is the area of the brain where growth hormone is
normally produced. We, the researchers at Massachusetts General Hospital, will establish the
effects of growth hormone replacement on cardiovascular parameters (laboratory tests, the
flexibility of the arteries, changes in heart rate) in women with growth hormone deficiency.
Our goal is to see if this therapy:
- has effects on women's cardiovascular risk markers (special blood tests which indicate
how healthy the heart and arteries are)
- has effects on women's types and levels of various substances circulating in their
blood
- in women affects the stiffness of their arteries and heart rate variability in parallel
with changes in cardiovascular risk markers
- has different effects depending on whether women are pre or post menopausal.
Participation in this study is expected to last approximately 12 months.
Reports of Suspected Genotropin (Somatropin) Side Effects
Headache (82),
Injection Site Pain (43),
Vomiting (27),
Injection Site Haemorrhage (25),
Fatigue (25),
Drug Ineffective (22),
Nausea (22),
Arthralgia (21),
Pyrexia (19),
Rash (19), more >>
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