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

2012. november 5. frissítette: 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

A tanulmány áttekintése

Állapot

Megszűnt

Körülmények

Beavatkozás / kezelés

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

30

Fázis

  • 3. fázis

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

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

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

11 év (Gyermek)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Nem véletlenszerű
  • Beavatkozó modell: Egyetlen csoportos hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: Szomatropin
Drog: Somatropin
liquid, daily, until final height Dosage: 0,46 mg/kg/week . The maximum dose should not exceed 50 µg/Kg/day

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Bone Age
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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])
Időkeret: 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])
Időkeret: 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])
Időkeret: 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])
Időkeret: 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])
Időkeret: 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])
Időkeret: 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
Időkeret: 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
Időkeret: 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])
Időkeret: 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])
Időkeret: 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

Egyéb eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Growth Velocity (GV)
Időkeret: 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])
Időkeret: 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])
Időkeret: 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
Időkeret: Baseline, Year 1, 2, 3
Baseline, Year 1, 2, 3
Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3
Időkeret: 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)

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Pfizer

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Hasznos linkek

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete

2000. szeptember 1.

Elsődleges befejezés (Tényleges)

2011. szeptember 1.

A tanulmány befejezése (Tényleges)

2011. szeptember 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2005. szeptember 9.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2005. szeptember 9.

Első közzététel (Becslés)

2005. szeptember 15.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Becslés)

2012. december 4.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2012. november 5.

Utolsó ellenőrzés

2012. november 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • 307-MET-9002-0009
  • A6281016

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

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Körülmények

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