Metabolic Endocrinology and Growth Hormone in Adults

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Brief Title

Metabolic Endocrinology and Growth Hormone in Adults

Official Title

Study on the Prescription of the Growth Hormone Saizen® for Adults in France and Follow-up of Treated Patients

Brief Summary

      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.
    

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.
    


Study Type

Observational


Primary Outcome

Longitudinal follow up of subjects treated with Saizen


Condition

Adult Growth Hormone Deficiency



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

90

Start Date

December 2003

Completion Date

September 2012

Primary Completion Date

September 2012

Eligibility 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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

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Administrative Informations


NCT ID

NCT01080755

Organization ID

IMP 24428


Responsible Party

Sponsor

Study Sponsor

Merck KGaA, Darmstadt, Germany


Study Sponsor

, , 


Verification Date

March 2014