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Completed

NCT Number: NCT00934063

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

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.

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Key information

Conditions

Growth Hormone Disorder Adult Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mainz, 55127, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

No treatment given

Other

Control group not receiving treatment

Primary outcomes

  1. 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

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

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

  2. Disease related absences from work

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

  3. Bone mineral density DXA Z-score lumbar

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

  4. Total cholesterol, HDL, LDL

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

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

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

  6. Waist-circumference

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

  7. Blood pressure

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

  8. Adverse Drug Reactions and Severe Adverse Drug Reactions

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

  9. Triceps skinfold thickness

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

  10. Upper arm circumference

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

  11. IGF-I (Insulin-like growth factor 1)

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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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)

Acronym: GET

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Jul 8, 2009
Registry last updated
Apr 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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