Treatment With Recombinant Human Growth Hormone (GH) in Children With Short Stature Secondary to a Long Term Corticoid Therapy

NCT00174187 | Terminated Phase 3 Results

• 2 other identifiers: 307-MET-9002-0009A6281016
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Conditions

Endocrine System Diseases

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at 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.

  Baseline, Year 3

• Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Final Height

  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.

  Baseline, when final height was reached (assessed up to Year 11)

• Change From Baseline in Weight Standard Deviation Score (SDS) at Final Height

  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.

  Baseline, when final height was reached (assessed up to Year 11)

• Puberty Stage at Final Height

  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.

  When final height was reached (assessed up to Year 11)

Secondary Outcomes (21)

• 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

Other Outcomes (5)

• Growth Velocity (GV)

  Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

• Growth Velocity Standard Deviation Score According to Chronological Age (GV [SDS/CA])

  Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

• Growth Velocity Standard Deviation Score According to Bone Age (GV [SDS/BA])

  Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Study Arms (1)

Somatropin

EXPERIMENTAL

Drug: Somatropin

Interventions

Somatropin DRUG

liquid, daily, until final height Dosage: 0,46 mg/kg/week . The maximum dose should not exceed 50 µg/Kg/day

Somatropin

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with juvenile arthritis or nephrotic syndrome
• Before or during puberty

You may not qualify if:

• Diabetes Type 1 and 2
• Endocrine disease, except well substituted hypothyroidism

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Pfizer Investigational Site

Paris, 75019, France

Location

Pfizer Investigational Site

Paris, 75743, France

Location

Related Publications (1)

• David H, Aupiais C, Louveau B, Quartier P, Jacqz-Aigrain E, Carel JC, Simon D. Growth Outcomes After GH Therapy of Patients Given Long-Term Corticosteroids for Juvenile Idiopathic Arthritis. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4578-4587. doi: 10.1210/jc.2017-01455.

  PMID: 29029101 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Endocrine System Diseases

Interventions

Human Growth Hormone

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Results for secondary and other pre-specified endpoints (except IGF-1) are reported for only up to 3 years because data beyond Year 3 was not summarized as the study was terminated due to Good Clinical Practice (GCP) non-compliance issues.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: September 1, 2000
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 4, 2012
• Results First Posted: December 4, 2012

Record last verified: 2012-11

Locations

FR (2)