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

5 listopada 2012 zaktualizowane przez: 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

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

30

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

11 lat do 17 lat (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Somatropina
Lek: Somatropin
liquid, daily, until final height Dosage: 0,46 mg/kg/week . The maximum dose should not exceed 50 µg/Kg/day

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Bone Age
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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])
Ramy czasowe: 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])
Ramy czasowe: 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])
Ramy czasowe: 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])
Ramy czasowe: 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])
Ramy czasowe: 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])
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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])
Ramy czasowe: 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])
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Growth Velocity (GV)
Ramy czasowe: 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])
Ramy czasowe: 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])
Ramy czasowe: 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
Ramy czasowe: Baseline, Year 1, 2, 3
Baseline, Year 1, 2, 3
Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Pfizer

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 września 2000

Zakończenie podstawowe (Rzeczywisty)

1 września 2011

Ukończenie studiów (Rzeczywisty)

1 września 2011

Daty rejestracji na studia

Pierwszy przesłany

9 września 2005

Pierwszy przesłany, który spełnia kryteria kontroli jakości

9 września 2005

Pierwszy wysłany (Oszacować)

15 września 2005

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

4 grudnia 2012

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

5 listopada 2012

Ostatnia weryfikacja

1 listopada 2012

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 307-MET-9002-0009
  • A6281016

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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Warunki

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