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
  Purpose

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.


Condition
Adult Growth Hormone Deficiency

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on the Prescription of the Growth Hormone Saizen® for Adults in France and Follow-up of Treated Patients

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA

Plasma


Enrollment: 90
Study Start Date: December 2003
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Adult subjects treated with Saizen, irrespective of whether it concerns a first time prescription or a renewal were enrolled in the study.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01080755     History of Changes
Other Study ID Numbers: IMP 24428
Study First Received: March 3, 2010
Last Updated: March 10, 2014
Health Authority: France : Agence nationale de sécurité du médicament et des produits de santé (ANSM)
France : The French National Authority for Health, Haute Autorité de Santé (HAS)
France : Commission nationale de l'informatique et des libertés (CNIL)

Keywords provided by Merck KGaA:
Adult Growth Hormone Deficiency
Pituitary
Saizen
Somatropin
Growth Hormone

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014