Clinical trial NCT00934063: An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin®
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Disorder
Adult Growth Hormone Deficiency
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-07-08
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Improvement of an integrated score which consists of Quality of Life (QoL), body composition, lipid metabolism, bone mineral density
timeFrame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Secondary outcomes:
measure: Health related quality of life (SF-36; EQ-5D)
timeFrame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
measure: Disease related absences from work
timeFrame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
measure: Bone mineral density DXA Z-score lumbar
timeFrame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
measure: Total cholesterol, HDL, LDL
timeFrame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
measure: Body composition: fat mass, fat-free mass, impedance (BIA)
timeFrame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
measure: Waist-circumference
timeFrame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
measure: Blood pressure
timeFrame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
measure: Adverse Drug Reactions and Severe Adverse Drug Reactions
timeFrame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
measure: Triceps skinfold thickness
timeFrame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
measure: Upper arm circumference
timeFrame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
measure: IGF-I (Insulin-like growth factor 1)
timeFrame: at 0, 3, 6, 12, 18 and 24 months after treatment initiation
Other outcomes:
Locations:
city: Mainz
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.