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

maanantai 5. marraskuuta 2012 päivittänyt: 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

Tutkimuksen yleiskatsaus

Tila

Lopetettu

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

30

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

11 vuotta - 17 vuotta (Lapsi)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Ei satunnaistettu
  • Inventiomalli: Yksittäinen ryhmätehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Somatropiini
Lääke: Somatropin
liquid, daily, until final height Dosage: 0,46 mg/kg/week . The maximum dose should not exceed 50 µg/Kg/day

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Bone Age
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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])
Aikaikkuna: 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])
Aikaikkuna: 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])
Aikaikkuna: 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])
Aikaikkuna: 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])
Aikaikkuna: 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])
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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])
Aikaikkuna: 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])
Aikaikkuna: 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

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Growth Velocity (GV)
Aikaikkuna: 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])
Aikaikkuna: 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])
Aikaikkuna: 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
Aikaikkuna: Baseline, Year 1, 2, 3
Baseline, Year 1, 2, 3
Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3
Aikaikkuna: 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)

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Pfizer

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus

Perjantai 1. syyskuuta 2000

Ensisijainen valmistuminen (Todellinen)

Torstai 1. syyskuuta 2011

Opintojen valmistuminen (Todellinen)

Torstai 1. syyskuuta 2011

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Perjantai 9. syyskuuta 2005

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 9. syyskuuta 2005

Ensimmäinen Lähetetty (Arvio)

Torstai 15. syyskuuta 2005

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Arvio)

Tiistai 4. joulukuuta 2012

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 5. marraskuuta 2012

Viimeksi vahvistettu

Torstai 1. marraskuuta 2012

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 307-MET-9002-0009
  • A6281016

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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Ehdot

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