An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin®

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Growth hormone deficiency
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Brief Title

An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin®

Official Title

A 24-month Prospective, Non-interventional, Observational Study on the Composite Clinical Endpoint (GET-Score) Reflecting Quality of Life, Body Composition and Cholesterol Metabolism in Patients Treated With Norditropin® (Somatropin)

Brief Summary

      This observational study is conducted in Europe. The aim of this observational study is to
      investigate the changes in a score (GET-score) which includes quality of life, body
      composition and cholesterol metabolism in patients on growth hormone treatment. The GET score
      stands for: Growth hormone deficiency and Efficacy of Treatment, and is a quantitative
      measurement of the efficacy of the treatment with growth hormone in adults.

Study Type

Observational

Primary Outcome

Improvement of an integrated score which consists of Quality of Life (QoL), body composition, lipid metabolism, bone mineral density

Secondary Outcome

 Health related quality of life (SF-36; EQ-5D)

Condition

Growth Hormone Disorder

Intervention

somatropin

Study Arms / Comparison Groups

 A
Description:

Publications

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

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

121

Start Date

July 2009

Completion Date

June 2014

Primary Completion Date

December 2013

Eligibility Criteria

        Inclusion Criteria:

          -  Severe acquired growth hormone deficiency

          -  No treatment with somatropin in the last 24 months before study participation

          -  Written informed consent

        Exclusion Criteria:

          -  Contraindications for the treatment with somatropin

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Global Clinical Registry (GCR, 1452), ,

Location Countries

Germany

Location Countries

Germany

Administrative Informations

NCT ID

NCT00934063

Organization ID

GH-3709

Responsible Party

Sponsor

Study Sponsor

Novo Nordisk A/S

Study Sponsor

Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S

Verification Date

April 2015