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)

Novo Nordisk A/S0 sites121 target enrollmentJuly 2009

ConditionsGrowth Hormone Disorder Adult Growth Hormone Deficiency

Interventionssomatropin No treatment given

Drugssomatropin

Overview

Phase: Not Applicable
Intervention: somatropin
Conditions: Growth Hormone Disorder
Sponsor: Novo Nordisk A/S
Enrollment: 121
Primary Endpoint: Improvement of an integrated score which consists of Quality of Life (QoL), body composition, lipid metabolism, bone mineral density
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

June 2014

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

A

Intervention: somatropin

B

Intervention: No treatment given

Outcomes

Primary Outcomes

Improvement of an integrated score which consists of Quality of Life (QoL), body composition, lipid metabolism, bone mineral density

Time Frame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation

Secondary Outcomes

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)