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

NCT00934063 | Completed

• 1 other identifier: GH-3709
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Growth Hormone Disorder; Adult Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

Study Arms (2)

A

Drug: somatropin

B

Other: No treatment given

Interventions

somatropin DRUG

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

A

No treatment given OTHER

Control group not receiving treatment

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Severe acquired growth hormone deficiency
• No treatment with somatropin in the last 24 months before study participation
• Written informed consent

You may not qualify if:

• Contraindications for the treatment with somatropin

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Mainz, 55127, Germany

Location

Related Publications (1)

• 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.

  PMID: 29433573 DERIVED

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2009
• First Posted: July 8, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: April 29, 2015

Record last verified: 2015-04

Locations

DE (1)