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

Condition(s) targeted: Growth Hormone Disorder; Adult Growth Hormone Deficiency

Intervention: somatropin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Global Clinical Registry (GCR, 1452), Study Director, Affiliation: Novo Nordisk A/S

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.

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Number and type of suspected serious adverse drug reactions (SADRs) during the study period

Secondary outcome:

Number of impaired glucose tolerance events during the study period

Number of other types of adverse events (AEs) during the study period

Effects on body composition (body fat percentage, lean body weight mass, bone density, bone mineral density)

Effects of insulin-like growth factor-1 (IGF-I) levels

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Tokyo 1000005, Japan

Clinical Trials at Novo Nordisk

Starting date: October 2009
Last updated: January 7, 2015