Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
First received: April 19, 2010
Last updated: January 7, 2015
Last verified: January 2015
This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® long-term treatment of growth hormone deficiency in adults.

Condition Intervention
Growth Hormone Disorder
Adult Growth Hormone Deficiency
Drug: somatropin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Long-term Safety and Efficacy of Norditropin® Formulation in Patients With AGHD

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Number and type of suspected serious adverse drug reactions (SADRs) during the study period [ Time Frame: after 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of impaired glucose tolerance events during the study period [ Time Frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years ] [ Designated as safety issue: Yes ]
  • Number of other types of adverse events (AEs) during the study period [ Time Frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years ] [ Designated as safety issue: Yes ]
  • Effects on body composition (body fat percentage, lean body weight mass, bone density, bone mineral density) [ Time Frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years ] [ Designated as safety issue: No ]
  • Effects of insulin-like growth factor-1 (IGF-I) levels [ Time Frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years ] [ Designated as safety issue: No ]

Enrollment: 387
Study Start Date: October 2009
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Norditropin® Drug: somatropin
Norditropin® (somatropin) prescribed at the discretion of the physician according to normal clinical practice. Safety and effectiveness data is recorded by the physician, and a Quality of Life form is completed by the patient, at visits 1 to 5.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with growth hormone deficiency including newly-diagnosed patients, who are considered to need treatment with Norditropin® (somatropin) or already on therapy with Norditropin® (somatropin) are eligible for inclusion in the study

Inclusion Criteria:

  • Severe adult growth hormone deficiency

Exclusion Criteria:

  • Known or suspected allergy to study product(s) or related products
  • Previous participation in the study
  • Diabetes Mellitus
  • Presence of malignant tumor(s)
  • Pregnant or likely to get pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109017

Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01109017     History of Changes
Other Study ID Numbers: GH-3811  U1111-1114-6250  JapicCTI-101122 
Study First Received: April 19, 2010
Last Updated: January 7, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Bone Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases

ClinicalTrials.gov processed this record on May 26, 2016