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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00934063
Other study ID # GH-3709
Secondary ID
Status Completed
Phase N/A
First received July 2, 2009
Last updated April 28, 2015
Start date July 2009
Est. completion date June 2014

Study information

Verified date April 2015
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 121
Est. completion date June 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Drug:
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
Other:
No treatment given
Control group not receiving treatment

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Health related quality of life (SF-36; EQ-5D) at 0, 3, 6, 12, 18 and 24 months after treatment initiation No
Secondary Disease related absences from work at 0, 3, 6, 12, 18 and 24 months after treatment initiation No
Secondary Bone mineral density DXA Z-score lumbar at 0, 3, 6, 12, 18 and 24 months after treatment initiation No
Secondary Total cholesterol, HDL, LDL at 0, 3, 6, 12, 18 and 24 months after treatment initiation No
Secondary Body composition: fat mass, fat-free mass, impedance (BIA) at 0, 3, 6, 12, 18 and 24 months after treatment initiation No
Secondary Waist-circumference at 0, 3, 6, 12, 18 and 24 months after treatment initiation No
Secondary Blood pressure at 0, 3, 6, 12, 18 and 24 months after treatment initiation No
Secondary Adverse Drug Reactions and Severe Adverse Drug Reactions at 0, 3, 6, 12, 18 and 24 months after treatment initiation Yes
Secondary Triceps skinfold thickness at 0, 3, 6, 12, 18 and 24 months after treatment initiation Yes
Secondary Upper arm circumference at 0, 3, 6, 12, 18 and 24 months after treatment initiation Yes
Secondary IGF-I (Insulin-like growth factor 1) at 0, 3, 6, 12, 18 and 24 months after treatment initiation No
See also
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