Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) in Children With Short Stature Secondary to a Long Term Corticoid Therapy. A Study of Efficacy and Safety.
Overview
- Phase
- Phase 3
- Intervention
- Somatropin
- Conditions
- Endocrine System Diseases
- Sponsor
- Pfizer
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief Summary
- To assess the effect of a long-term treatment by Genotonorm on linear growth in children with short stature receiving steroid therapy
- To assess the effect of a long term treatment with Genotonorm on bone mineralisation
- To assess the effect of a long term treatment with Genotonorm on body composition
Detailed Description
This trial terminated on 10-Jun-2011 due to prolonged issues with drug accountability and data collection discrepancies. The decision to terminate was not based on any safety concerns.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Children with juvenile arthritis or nephrotic syndrome
- •Before or during puberty
Exclusion Criteria
- •Diabetes Type 1 and 2
- •Endocrine disease, except well substituted hypothyroidism
Arms & Interventions
Somatropin
Intervention: Somatropin
Outcomes
Primary Outcomes
Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3
Time Frame: Baseline, Year 3
Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS/CA was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Final Height
Time Frame: Baseline, when final height was reached (assessed up to Year 11)
Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS/CA was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
Change From Baseline in Weight Standard Deviation Score (SDS) at Final Height
Time Frame: Baseline, when final height was reached (assessed up to Year 11)
Body weight was measured using a balance scale. Weight SDS was obtained by measuring the weight, subtracting age- and gender-appropriate mean weight and dividing the result by standard deviation of that mean (as obtained from age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant's value was relative to the mean of the reference population.
Puberty Stage at Final Height
Time Frame: When final height was reached (assessed up to Year 11)
Pubertal stage (graded from I to V for breast development and pubic hair development) according to the Tanner's method was collected. A low stage (Stage I) corresponds to a pre-pubertal stage and a high stage (Stage V) to an adult stage.
Secondary Outcomes
- Bone Age(Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
- Lean Body Mass(Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
- Annual Percent Change in Lean Body Mass at Year 1, 2 and 3(Baseline, Year 1, 2, 3)
- Percent Change From Baseline in Lean Body Mass at Year 3(Baseline, Year 3)
- Lean Body Mass as Percentage of Total Weight(Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
- Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA)(Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
- Fat Mass(Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
- Annual Percent Change in Fat Mass at Year 1, 2 and 3(Baseline, Year 1, 2, 3)
- Percent Change From Baseline in Fat Mass at Year 3(Baseline, Year 3)
- Fat Mass as Percentage of Total Weight(Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
- Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA)(Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
- Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS])(Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
- Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA])(Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
- Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage])(Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
- Bone Mineral Density of Total Body (BMD [TB])(Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
- Bone Mineral Density of Lumbar Spine (BMD [LS])(Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
- Bone Mineral Content of Total Body (BMC [TB])(Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
- Annual Percent Change in Bone Mineral Content of Total Body (BMC [TB]) at Year 1, 2 and 3(Baseline, Year 1, 2, 3)
- Percent Change From Baseline in Bone Mineral Content of Total Body (BMC [TB]) at Year 3(Baseline, Year 3)
- Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA])(Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
- Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage])(Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11)