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

NCT ID: NCT00934063

Last Updated: 2015-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Growth Hormone Disorder Adult Growth Hormone Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A

somatropin

Intervention Type DRUG

For s.c. (under the skin) injection. Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

B

No treatment given

Intervention Type OTHER

Control group not receiving treatment

Interventions

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somatropin

For s.c. (under the skin) injection. Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Intervention Type DRUG

No treatment given

Control group not receiving treatment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Mainz, , Germany

Site Status

Countries

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Germany

References

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Kann PH, Bergmann S, Bidlingmaier M, Dimopoulou C, Pedersen BT, Stalla GK, Weber MM, Meckes-Ferber S. Design of the Growth hormone deficiency and Efficacy of Treatment (GET) score and non-interventional proof of concept study. BMC Endocr Disord. 2018 Feb 13;18(1):10. doi: 10.1186/s12902-018-0237-3.

Reference Type DERIVED
PMID: 29433573 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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GH-3709

Identifier Type: -

Identifier Source: org_study_id

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