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

5 november 2012 bijgewerkt door: 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

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

30

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Frankrijk
      • Paris, Frankrijk, 75019
        • Pfizer Investigational Site
      • Paris, Frankrijk, 75743
        • Pfizer Investigational Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

11 jaar tot 17 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Somatropine
Geneesmiddel: Somatropin
liquid, daily, until final height Dosage: 0,46 mg/kg/week . The maximum dose should not exceed 50 µg/Kg/day

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3
Tijdsspanne: 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.
Baseline, Year 3
Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Final Height
Tijdsspanne: 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.
Baseline, when final height was reached (assessed up to Year 11)
Change From Baseline in Weight Standard Deviation Score (SDS) at Final Height
Tijdsspanne: 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.
Baseline, when final height was reached (assessed up to Year 11)
Puberty Stage at Final Height
Tijdsspanne: 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.
When final height was reached (assessed up to Year 11)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Bone Age
Tijdsspanne: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Bone age was determined by the Greulich and Pyle method using left wrist and hand X-ray.
Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Lean Body Mass
Tijdsspanne: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Lean body mass, a measurement of body composition, was assessed by Dual Energy X-ray Absorptiometry (DEXA) scan.
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
Tijdsspanne: Baseline, Year 1, 2, 3
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.
Baseline, Year 1, 2, 3
Percent Change From Baseline in Lean Body Mass at Year 3
Tijdsspanne: Baseline, Year 3
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.
Baseline, Year 3
Lean Body Mass as Percentage of Total Weight
Tijdsspanne: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Lean body mass, a measurement of body composition, was assessed by DEXA scan.
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)
Tijdsspanne: 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.
Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Fat Mass
Tijdsspanne: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Fat mass, a measurement of body composition, was assessed by DEXA scan.
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
Tijdsspanne: Baseline, Year 1, 2, 3
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.
Baseline, Year 1, 2, 3
Percent Change From Baseline in Fat Mass at Year 3
Tijdsspanne: Baseline, Year 3
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.
Baseline, Year 3
Fat Mass as Percentage of Total Weight
Tijdsspanne: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Fat mass, a measurement of body composition, was assessed by DEXA scan.
Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA)
Tijdsspanne: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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.
Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS])
Tijdsspanne: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
BMAD (LS) was assessed by DEXA scan.
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])
Tijdsspanne: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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.
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])
Tijdsspanne: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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.
Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Bone Mineral Density of Total Body (BMD [TB])
Tijdsspanne: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
BMD (TB) was assessed by DEXA scan.
Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Bone Mineral Density of Lumbar Spine (BMD [LS])
Tijdsspanne: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
BMD (LS) was assessed by DEXA scan.
Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Bone Mineral Content of Total Body (BMC [TB])
Tijdsspanne: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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.
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
Tijdsspanne: Baseline, Year 1, 2, 3
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.
Baseline, Year 1, 2, 3
Percent Change From Baseline in Bone Mineral Content of Total Body (BMC [TB]) at Year 3
Tijdsspanne: 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
Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA])
Tijdsspanne: 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
Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage])
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Growth Velocity (GV)
Tijdsspanne: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Growth velocity measures the annual rate of increase in height.
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])
Tijdsspanne: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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
Growth Velocity Standard Deviation Score According to Bone Age (GV [SDS/BA])
Tijdsspanne: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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.
Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Insulin-like Growth Factor-1 (IGF-1) Concentration up to Year 3
Tijdsspanne: Baseline, Year 1, 2, 3
Baseline, Year 1, 2, 3
Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3
Tijdsspanne: 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)
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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Pfizer

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2000

Primaire voltooiing (Werkelijk)

1 september 2011

Studie voltooiing (Werkelijk)

1 september 2011

Studieregistratiedata

Eerst ingediend

9 september 2005

Eerst ingediend dat voldeed aan de QC-criteria

9 september 2005

Eerst geplaatst (Schatting)

15 september 2005

Updates van studierecords

Laatste update geplaatst (Schatting)

4 december 2012

Laatste update ingediend die voldeed aan QC-criteria

5 november 2012

Laatst geverifieerd

1 november 2012

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 307-MET-9002-0009
  • A6281016

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Endocriene systeemziekten

Klinische onderzoeken op Somatropin

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Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Albania

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

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