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

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)

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.

Study Overview

• Status: Completed
• Conditions: Growth Hormone Disorder; Adult Growth Hormone Deficiency
• Intervention / Treatment: Drug: somatropin; Other: No treatment given

• Study Type: Observational
• Enrollment (Actual): 121

Contacts and Locations

Study Locations

• Germany
  • Mainz, Germany, 55127

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with acquired growth hormone deficiency who have been deemed appropriate to receive Norditropin® as treatment and as part of routine out-patient care by the prescribing physician.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A	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
B	Other: No treatment given; Control group not receiving treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• Kann PH, Bergmann S, Bidlingmaier M, Dimopoulou C, Pedersen BT, Stalla GK, Weber MM, Meckes-Ferber S. Design of the Growth hormone deficiency and Efficacy of Treatment (GET) score and non-interventional proof of concept study. BMC Endocr Disord. 2018 Feb 13;18(1):10. doi: 10.1186/s12902-018-0237-3.

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: July 2, 2009
• First Submitted That Met QC Criteria: July 7, 2009
• First Posted (Estimate): July 8, 2009

Study Record Updates

• Last Update Posted (Estimate): April 29, 2015
• Last Update Submitted That Met QC Criteria: April 28, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: GH-3709