Clinical Trial: An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone)

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Registry of Patients Being Treated With Norditropin®, Recombinant Human Growth Hormone

Brief Summary: This study is conducted in the United States of America (USA). The aim of this observational study is to collect data concerning the treatment outcomes and safety for children and adults who are prescribed Norditropin®. Specific objectives include: 1) developing models defining the relationship of Norditropin dose to changes in insulin-like growth factor (IGF-I) and treatment outcomes, accounting for independent factors such as age, gender and puberty and 2) determining the relative predictive values of peak growth hormone (GH) and IGF-I levels and other factors before treatment to clinical outcomes.

Detailed Summary:
Sponsor: Novo Nordisk A/S

Current Primary Outcome:

  • Change in height, measured as the height standard deviation score (HSDS), from the measurement made by the physician at study entry to the most recent clinic observation, end of GH treatment, de-registration, or change of clinic. [ Time Frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study. ]
  • Change in waist/hip circumference ratio for adult patients [ Time Frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study ]


Original Primary Outcome: Change in height, measured as the height standard deviation score (HSDS), from the measurement made by the physician at study entry to the most recent clinic observation, end of GH treatment, de-registration, or change of clinic. [ Time Frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study. ]

Current Secondary Outcome:

  • Short-term: Height, Height velocity, Height velocity standard deviation score (SDS), predicted adult height, height SDS for bone age, Proportion achieving height SDS > -2 at end of observational duration period [ Time Frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study. ]
  • Final Height (or Adult height), Final Height SDS, near-adult height, near-adult height SDS, Final Height - Target Height, Final height - predicted adult height, height age [ Time Frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study. ]
  • Final Height SDS - Target Height SDS, Final height SDS - predicted adult height SDS [ Time Frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study. ]
  • Proportion achieving HSDS of more than -2 at final height [ Time Frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study. ]
  • Weight, waist circumference, and hip circumference for adult patients [ Time Frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study ]


Original Secondary Outcome:

  • Short-term: Height, Height velocity, Height velocity standard deviation score (SDS), predicted adult height, height SDS for bone age, Proportion achieving height SDS > -2 at end of observational duration period [ Time Frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study. ]
  • Final Height (or Adult height), Final Height SDS, near-adult height, near-adult height SDS, Final Height - Target Height, Final height - predicted adult height, height age [ Time Frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study. ]
  • Final Height SDS - Target Height SDS, Final height SDS - predicted adult height SDS [ Time Frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study. ]
  • Proportion achieving HSDS > -2 at final height [ Time Frame: measurement made by physician at study entry, annually, or more frequently at physician discretion during the study. ]


Information By: Novo Nordisk A/S

Dates:
Date Received: November 5, 2009
Date Started: June 24, 2002
Date Completion:
Last Updated: April 11, 2017
Last Verified: April 2017