DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Growth Hormone Disorder; Adult Growth Hormone Deficiency

Intervention: somatropin (Drug); No treatment given (Other)

Phase: N/A

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Global Clinical Registry (GCR, 1452), Study Director, Affiliation: Novo Nordisk A/S

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.

Clinical Details

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)

Study design: Observational Model: Cohort, Time Perspective: Prospective

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

Secondary outcome:

Health related quality of life (SF-36; EQ-5D)

Disease related absences from work

Bone mineral density DXA Z-score lumbar

Total cholesterol, HDL, LDL

Body composition: fat mass, fat-free mass, impedance (BIA)

Waist-circumference

Blood pressure

Adverse Drug Reactions and Severe Adverse Drug Reactions

Triceps skinfold thickness

Upper arm circumference

IGF-I (Insulin-like growth factor 1)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Mainz 55127, Germany
Additional Information

Clinical Trials at Novo Nordisk

Starting date: July 2009
Last updated: April 28, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017