Treatment With Recombinant Human Growth Hormone (GH) in Children With Short Stature Secondary to a Long Term Corticoid Therapy
2012年11月5日 更新者：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
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
30
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Paris、フランス、75019
- Pfizer Investigational Site
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Paris、フランス、75743
- Pfizer Investigational Site
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
11年～17年 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：ソマトロピン
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3
時間枠：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
時間枠：Baseline, when final height was reached (assessed up to Year 11)
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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, 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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Bone Age
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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])
時間枠：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])
時間枠：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])
時間枠：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])
時間枠：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])
時間枠：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])
時間枠：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
時間枠：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
時間枠：Baseline, Year 3
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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.
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Baseline, Year 3
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Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA])
時間枠：Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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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.
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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])
時間枠：Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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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.
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Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Growth Velocity (GV)
時間枠：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])
時間枠：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.
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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 Bone Age (GV [SDS/BA])
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
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出版物と役立つリンク
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2000年9月1日
一次修了 (実際)
2011年9月1日
研究の完了 (実際)
2011年9月1日
試験登録日
最初に提出
2005年9月9日
QC基準を満たした最初の提出物
2005年9月9日
最初の投稿 (見積もり)
2005年9月15日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年12月4日
QC基準を満たした最後の更新が送信されました
2012年11月5日
最終確認日
2012年11月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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