Metabolic Endocrinology and Growth Hormone in Adults: An Observational Study on the Prescription of the Growth Hormone Saizen for Adults in France and Follow-up of Treated Patients

2014-08-27 03:15:28 | BioPortfolio


This is a multicentric, longitudinal, observational study with the prospective follow-up of Adult subjects with Growth Hormone Deficiency (AGHD) being treated with Saizen, every six months in the first year and then annually. At the request of health authorities, the sponsor has arranged for the follow-up of prescriptions and treated subjects within the scope of this indication.


Adult growth hormone deficiency can lead to various effects. In some subjects, an increase is observed in the body fat mass and often, there is an increase in blood lipid levels, which also leads to an increase in risk of death by cardiovascular diseases. Sometimes muscle mass is reduced, thus affecting physical performances, which cannot be rectified by exercise alone. And finally, there is a decline in bone density, which increases the risk of fractures. In general, most of the subjects with inadequate growth hormone secretion also show a deficiency in other hormones secreted by the hypophysis (pituitary gland). In spite of an adequate substitution of the possible related hormonal deficiency, these subjects also present psychomotor retardation, decrease in tonus and vitality, emotional lability, a feeling of social isolation and sexual problems.

In France, marketing approval had been granted to different recombinant growth hormones (GH), including Saizen, for treating AGHD subjects. The indication of Saizen in adults is as follows: marked deficiency in GH documented by a dynamic test indicating somatotroph deficiency. The therapeutic benefits of Saizen as well as its good tolerance has been demonstrated in the marketing approval indications. It has been shown that this treatment results in a significant improvement in the body composition and cardiac function of AGHD subjects.

After receiving the marketing approval for Saizen on the basis of this indication in adults, the sponsor, has set-up a study in France, at the request of health authorities, to ensure a follow-up of the prescriptions and treated subjects in the use of Saizen post marketing approval. This request of the health authorities is also mentioned in the Treatment Information Form.


- To ensure the longitudinal follow-up of GH-deficient adult subjects treated with Saizen in France, with the description:

1. of the terms and conditions of prescription,

2. of the demographic and clinical characteristics of subjects,

3. of subjects' compliance

4. of product tolerance.

The data collected in this study will concern the demography, medical history, clinical and biological characteristics of the subjects, the terms and conditions of prescription of Saizen, its tolerance and subjects' compliance. The information will be gathered by all hospital endocrinologist (approximately 200 potential prescribing doctors in France). The prescribing doctor shall care for the subjects on account of the treatment and for medical reasons as per his/her regular practice. The period of inclusion of subjects in the cohort is 3 years. The extension of this inclusion period will be discussed with the health authorities during the third year of inclusion. The follow-up period for each subject included will be 5 years. This follow-up will be carried out at regular intervals of 6 months in the first year (2 intermediate visits before 6 months are also available) and then of 12 months in the subsequent years.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Adult Growth Hormone Deficiency


Active, not recruiting


Merck KGaA

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:15:28-0400

Clinical Trials [1769 Associated Clinical Trials listed on BioPortfolio]

Diagnosing Adult Growth Hormone Deficiency

The purpose of this study was to validate the growth hormone releasing hormone (GHRH) plus arginine (GHRH+arg) stimulation test and it´s cut-off limits for diagnosis of adult growth hormo...

Adult Growth Hormone Deficiency and Cardiovascular Risk

This protocol will assess the cardiovascular risk associated with growth hormone deficiency in adults. We will use multiple modalities to assess risk for heart attacks or strokes includin...

Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency

The Macimorelin-GHST (growth hormone stimulation test) will be compared with the ITT (insulin tolerance test) in an open-label, randomized, 2-way crossover Trial. The trial will include su...

Extension Study on Safety of Long-Term Growth Hormone Replacement in Adult Patients With Growth Hormone Deficiency

To evaluate long-term safety of growth hormone replacement in adult patients with growth hormone deficiency

Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency

The purpose of this study is to evaluate the efficacy and safety of recombinant human growth hormone on adult growth hormone deficiency

PubMed Articles [13724 Associated PubMed Articles listed on BioPortfolio]

Identifying Potentially Modifiable Factors Associated with Treatment Non-Adherence in Paediatric Growth Hormone Deficiency: A Systematic Review.

Despite the developments of recombinant growth hormone (rhGH) treatment and the benefits in long-term clinical health outcomes, evidence has shown that many children with growth hormone deficiency (GH...

Targeted literature review of the humanistic and economic burden of adult growth hormone deficiency.

Quality of life (QoL) and health economic data are becoming increasingly important factors in healthcare decision-making. While there is a wealth of information establishing the benefit of growth horm...

Is growth hormone administration essential for in vitro fertilization treatment of female patients with growth hormone deficiency?

Available evidence suggests that the fertility of growth hormone deficient female patients could be decreased, although the responsible mechanisms are unknown. Taking into account the multiple effects...

Macimorelin as a Diagnostic Test for Adult Growth Hormone Deficiency.

Diagnosis of adult growth hormone deficiency (AGHD) is challenging and often requires confirmation with a GH stimulation test (GHST). The insulin tolerance test (ITT) is considered the gold standard G...

Incidence and Outcomes of Pituitary Microadenomas in Children with Short Stature/Growth Hormone Deficiency.

Patients with short stature (SS)/growth hormone deficiency (GHD) and precocious puberty (PP) undergo brain MRI to evaluate for structural brain abnormalities or pituitary lesions, and pituitary microa...

Medical and Biotech [MESH] Definitions

A form of dwarfism caused by complete or partial GROWTH HORMONE deficiency, resulting from either the lack of GROWTH HORMONE-RELEASING FACTOR from the HYPOTHALAMUS or from the mutations in the growth hormone gene (GH1) in the PITUITARY GLAND. It is also known as Type I pituitary dwarfism. Human hypophysial dwarf is caused by a deficiency of HUMAN GROWTH HORMONE during development.

A 191-amino acid polypeptide hormone secreted by the human adenohypophysis (PITUITARY GLAND, ANTERIOR), also known as GH or somatotropin. Synthetic growth hormone, termed somatropin, has replaced the natural form in therapeutic usage such as treatment of dwarfism in children with growth hormone deficiency.

An autosomal recessive disorder characterized by short stature, defective GROWTH HORMONE RECEPTOR, and failure to generate INSULIN-LIKE GROWTH FACTOR I by GROWTH HORMONE. Laron syndrome is not a form of primary pituitary dwarfism (GROWTH HORMONE DEFICIENCY DWARFISM) but the result of mutation of the human GHR gene on chromosome 5.

The biologically active fragment of human growth hormone-releasing factor, consisting of GHRH(1-29)-amide. This N-terminal sequence is identical in several mammalian species, such as human, pig, and cattle. It is used to diagnose or treat patients with GROWTH HORMONE deficiency.

A pituitary tumor that secretes GROWTH HORMONE. In humans, excess HUMAN GROWTH HORMONE leads to ACROMEGALY.

More From BioPortfolio on "Metabolic Endocrinology and Growth Hormone in Adults: An Observational Study on the Prescription of the Growth Hormone Saizen for Adults in France and Follow-up of Treated Patients"

Quick Search


Relevant Topics

Endocrine Disorders
Endocrine disorders are grouped into two categories: hormone imbalance - when a gland produces too much or too little of an endocrine hormone development of lesions (such as nodules or tumors) in the endocrine system, which may or may not affect...

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Diabetes Diabetes Endocrine Obesity Oxycontin Renal Disease Thyroid Disorders Endocrinology is the study of the endocrine glands and the hormones that they secrete (Oxford Medical Dictionary). There are several groups of h...

Searches Linking to this Trial