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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00934063

Acronym

GET

Enrollment

121

Registered

2009-07-08

Start date

2009-07-31

Completion date

2014-06-30

Last updated

2015-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Growth Hormone Deficiency, Growth Hormone Disorder

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.

Interventions

DRUGsomatropin

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

OTHERNo treatment given

Control group not receiving treatment

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Improvement of an integrated score which consists of Quality of Life (QoL), body composition, lipid metabolism, bone mineral density	at 0, 3, 6, 12, 18 and 24 months after treatment initiation

Secondary

Measure	Time frame
Disease related absences from work	at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Bone mineral density DXA Z-score lumbar	at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Total cholesterol, HDL, LDL	at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Body composition: fat mass, fat-free mass, impedance (BIA)	at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Waist-circumference	at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Health related quality of life (SF-36; EQ-5D)	at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Adverse Drug Reactions and Severe Adverse Drug Reactions	at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Triceps skinfold thickness	at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Upper arm circumference	at 0, 3, 6, 12, 18 and 24 months after treatment initiation
IGF-I (Insulin-like growth factor 1)	at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Blood pressure	at 0, 3, 6, 12, 18 and 24 months after treatment initiation

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026