Effect of Two Years of Treatment With Norditropin® SimpleXx® on Bone Mineral Density in Young Adults With Childhood-Onset Growth Hormone Deficiency

Novo Nordisk A/S1 site in 1 country161 target enrollmentFebruary 2002

ConditionsGrowth Hormone Disorder Adult Growth Hormone Deficiency

Drugssomatropin

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Growth Hormone Disorder
Sponsor: Novo Nordisk A/S
Enrollment: 161
Locations: 1
Primary Endpoint: Changes in bone mineralisation
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This trial is conducted in Europe. Growth Hormone in young adults with growth hormone deficiency in childhood. This trial compares a treated group of patients with an untreated group of patients.

Registry

clinicaltrials.gov

Start Date

February 2002

End Date

July 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Child-hood onset growth hormone deficiency
•Subjects received growth hormone replacement therapy during pre-puberty and puberty

Exclusion Criteria

•GH treatment during the month preceding randomisation
•Treatment within the previous 6 months with medication that may affect bone mineral density
•Diseases which may affect bone metabolism