NCT00184678CompletedPhase 3
Effect of Two Years of Treatment With Norditropin® SimpleXx® on Bone Mineral Density in Young Adults With Childhood-Onset Growth Hormone Deficiency
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 161
- Locations
- 31
- Primary Endpoint
- Changes in bone mineralisation
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 25 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Changes in bone mineralisation
Time Frame: After 2 years treatment
Secondary Outcomes
- Other markers of bone mineral content.
Investigators
Study Sites (31)
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