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

Adult Growth Hormone Deficiency Clinical Trial

— GET  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00934063
• Other study ID #: GH-3709
• 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

Related Conditions & MeSH terms

• Adult Growth Hormone Deficiency
• Dwarfism, Pituitary
• Growth Hormone Disorder

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

External Links

•   Clinical Trials at Novo Nordisk