Treatment With Recombinant Human Growth Hormone (GH) in Children With Short Stature Secondary to a Long Term Corticoid Therapy
5 novembre 2012 mis à jour par: Pfizer
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.
- 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
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
30
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Paris, France, 75019
- Pfizer Investigational Site
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Paris, France, 75743
- Pfizer Investigational Site
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
11 ans à 17 ans (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Somatropine
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liquid, daily, until final height Dosage: 0,46 mg/kg/week .
The maximum dose should not exceed 50 µg/Kg/day
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3
Délai: Baseline, Year 3
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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.
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Baseline, Year 3
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Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Final Height
Délai: 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.
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Baseline, when final height was reached (assessed up to Year 11)
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Change From Baseline in Weight Standard Deviation Score (SDS) at Final Height
Délai: Baseline, when final height was reached (assessed up to Year 11)
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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.
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Baseline, when final height was reached (assessed up to Year 11)
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Puberty Stage at Final Height
Délai: When final height was reached (assessed up to Year 11)
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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.
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When final height was reached (assessed up to Year 11)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Bone Age
Délai: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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Bone age was determined by the Greulich and Pyle method using left wrist and hand X-ray.
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Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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Lean Body Mass
Délai: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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Lean body mass, a measurement of body composition, was assessed by Dual Energy X-ray Absorptiometry (DEXA) scan.
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Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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Annual Percent Change in Lean Body Mass at Year 1, 2 and 3
Délai: Baseline, Year 1, 2, 3
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Lean body mass, a measurement of body composition, was assessed by DEXA scan.
Annual percent change: (Lean body mass at current year minus lean body mass at previous year) divided by lean body mass at previous year, multiplied by 100.
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Baseline, Year 1, 2, 3
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Percent Change From Baseline in Lean Body Mass at Year 3
Délai: Baseline, Year 3
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Lean body mass, a measurement of body composition, was assessed by DEXA scan.
Percent change: (Lean body mass at Year 3 minus lean body mass at baseline) divided by lean body mass at baseline, multiplied by 100.
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Baseline, Year 3
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Lean Body Mass as Percentage of Total Weight
Délai: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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Lean body mass, a measurement of body composition, was assessed by DEXA scan.
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Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA)
Délai: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
|
Lean body mass was assessed by DEXA scan.
Lean body mass SDS/CA was obtained by measuring lean body mass, subtracting the chronological age- and gender-appropriate mean lean body mass 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.
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Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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Fat Mass
Délai: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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Fat mass, a measurement of body composition, was assessed by DEXA scan.
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Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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Annual Percent Change in Fat Mass at Year 1, 2 and 3
Délai: Baseline, Year 1, 2, 3
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Fat mass, a measurement of body composition, was assessed by DEXA scan.
Annual percent change: (Fat mass at current year minus fat mass at previous year) divided by fat mass at previous year, multiplied by 100.
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Baseline, Year 1, 2, 3
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Percent Change From Baseline in Fat Mass at Year 3
Délai: Baseline, Year 3
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Fat mass, a measurement of body composition, was assessed by DEXA scan.
Percent change: (Fat mass at Year 3 minus fat mass at baseline) divided by fat mass at baseline, multiplied by 100.
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Baseline, Year 3
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Fat Mass as Percentage of Total Weight
Délai: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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Fat mass, a measurement of body composition, was assessed by DEXA scan.
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Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA)
Délai: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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Fat mass was assessed by DEXA scan.
Fat mass SDS/CA was obtained by measuring fat mass, subtracting chronological age- and gender-appropriate mean fat mass 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.
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Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS])
Délai: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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BMAD (LS) was assessed by DEXA scan.
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Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA])
Délai: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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BMAD (LS) was assessed by DEXA scan.
BMAD (LS) (SDS/CA) was obtained by measuring the BMAD (LS), subtracting chronological age- and gender-appropriate mean BMAD (LS) 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.
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Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage])
Délai: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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BMAD (LS) was assessed by DEXA scan.
BMAD (LS) (SDS/Tanner Puberty Stage) was obtained by measuring BMAD (LS), subtracting Tanner puberty stage- and gender-appropriate mean BMAD (LS) and dividing the result by standard deviation of that mean (as obtained from Tanner puberty stage- 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.
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Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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Bone Mineral Density of Total Body (BMD [TB])
Délai: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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BMD (TB) was assessed by DEXA scan.
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Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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Bone Mineral Density of Lumbar Spine (BMD [LS])
Délai: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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BMD (LS) was assessed by DEXA scan.
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Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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Bone Mineral Content of Total Body (BMC [TB])
Délai: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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DEXA scan of BMC was used to evaluate potential bone effects of treatment.
BMC is an estimate of the amount of mineral (such as calcium) in the bone.
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Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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Annual Percent Change in Bone Mineral Content of Total Body (BMC [TB]) at Year 1, 2 and 3
Délai: Baseline, Year 1, 2, 3
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BMC is an estimate of the amount of mineral (such as calcium) in the bone.
Annual percent change: (BMC [TB] at current year minus BMC [TB] at previous year) divided by BMC [TB] at previous year, multiplied by 100.
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Baseline, Year 1, 2, 3
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Percent Change From Baseline in Bone Mineral Content of Total Body (BMC [TB]) at Year 3
Délai: Baseline, Year 3
|
BMC is an estimate of the amount of mineral (such as calcium) in the bone.
Percent change: (BMC [TB] at Year 3 minus BMC [TB] at baseline) divided by BMC [TB] at baseline, multiplied by 100.
|
Baseline, Year 3
|
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Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA])
Délai: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
|
BMC (TB) was measured by DEXA scan.
BMC (TB) (SDS/CA) was obtained by measuring BMC (TB), subtracting the chronological age- and gender-appropriate mean BMC (TB) 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 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
|
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Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage])
Délai: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
|
BMC (TB) was measured by DEXA scan.
BMC (TB) (SDS/Tanner Puberty Stage) was obtained by measuring BMC (TB), subtracting the Tanner puberty stage- and gender-appropriate mean BMC (TB) and dividing the result by standard deviation of that mean (as obtained from Tanner puberty stage- 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 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Growth Velocity (GV)
Délai: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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Growth velocity measures the annual rate of increase in height.
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Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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Growth Velocity Standard Deviation Score According to Chronological Age (GV [SDS/CA])
Délai: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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GV measures the annual rate of increase in height.
GV (SDS/CA) was obtained by measuring GV, subtracting the chronological age- and gender-appropriate mean GV 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 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
|
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Growth Velocity Standard Deviation Score According to Bone Age (GV [SDS/BA])
Délai: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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GV measures the annual rate of increase in height.
GV (SDS/BA) was obtained by measuring GV, subtracting the bone age- and gender-appropriate mean GV and dividing the result by standard deviation of that mean (as obtained from bone 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.
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Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
|
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Insulin-like Growth Factor-1 (IGF-1) Concentration up to Year 3
Délai: Baseline, Year 1, 2, 3
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Baseline, Year 1, 2, 3
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Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3
Délai: Year 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10; 0.5 and 1 year after somatropin discontinuation, Final Height (assessed up to Year 11)
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Year 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10; 0.5 and 1 year after somatropin discontinuation, Final Height (assessed up to Year 11)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
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Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2000
Achèvement primaire (Réel)
1 septembre 2011
Achèvement de l'étude (Réel)
1 septembre 2011
Dates d'inscription aux études
Première soumission
9 septembre 2005
Première soumission répondant aux critères de contrôle qualité
9 septembre 2005
Première publication (Estimation)
15 septembre 2005
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
4 décembre 2012
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 novembre 2012
Dernière vérification
1 novembre 2012
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 307-MET-9002-0009
- A6281016
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .