Metabolic Endocrinology and Growth Hormone in Adults (MEGHA FRANCE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01080755
First received: March 3, 2010
Last updated: March 10, 2014
Last verified: March 2014

March 3, 2010
March 10, 2014
December 2003
September 2012   (final data collection date for primary outcome measure)
Longitudinal follow up of subjects treated with Saizen [ Time Frame: Data to be collected from the start of the follow-up period up to 5 years (every six months in the first year and then annually) ] [ Designated as safety issue: Yes ]
Demographic data and medical history (date of birth, sex, diagnosis of the hypophyseal pathology and the GH deficit, other hormonal abnormalities, etc.); Clinical and biological data (size, weight, vital signs, body composition, cardiac function, insulin growth factor -1 (IGF1), blood lipids, etc.); Data on the terms and conditions of prescription of the GH (start date, dose, injection cycle, modifications or discontinuation of treatment); Related treatments and Information of the side effects and problems linked to the injection.
Same as current
Complete list of historical versions of study NCT01080755 on ClinicalTrials.gov Archive Site
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Metabolic Endocrinology and Growth Hormone in Adults
Study on the Prescription of the Growth Hormone Saizen® for Adults in France and Follow-up of Treated Patients

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.

OBJECTIVES

  • 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

Plasma

Probability Sample

Adult subjects treated with Saizen, irrespective of whether it concerns a first time prescription or a renewal were enrolled in the study.

Adult Growth Hormone Deficiency
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult subjects treated with Saizen, irrespective of whether it concerns a first time prescription or a renewal were enrolled in the study.
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01080755
IMP 24428
No
Merck KGaA
Merck KGaA
Not Provided
Not Provided
Merck KGaA
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP