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

Completed

• Conditions: Growth Hormone Disorder; Adult Growth Hormone Deficiency
• Interventions: Other: No treatment given; Drug: somatropin

• Registration Number: NCT00934063
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-02
• Study First Submitted QC: 2009-07-07
• Study First Posted: 2009-07-08
• Primary Completion: 2013-12
• Study Completion: 2014-06
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-28
• Last Update Posted: 2015-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
B	No treatment given	-
A	somatropin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Health related quality of life (SF-36; EQ-5D)	at 0, 3, 6, 12, 18 and 24 months after treatment initiation
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
Blood pressure	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