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Trial · Interventional

TerminatedPhase 3Results postedRegistry data

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

NCTNCT00174187 (opens ClinicalTrials.gov in a new tab)Other id307-MET-9002-0009Other idA6281016
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Overview

Status
Terminated
Phase
Phase 3
Enrollment
30 participants (actual)
Sponsor
Pfizer · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

France

Start
Sept 2000
Primary completion
Sept 2011
Completion
Sept 2011
First posted
15 Sept 2005 (estimated)
Last update posted
4 Dec 2012 (estimated)
Conditions
Endocrine System Diseases

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2000200220042006200820102012
  1. Ph 3

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

    NCT00174187

    Sept 2000 to Sept 2011

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

* 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

Interventions

  • SomatropinDrug

Arms1

  • Experimental

    Somatropin

Primary outcomes4

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3

    Time frame · Baseline, Year 3

    Registry description

    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.

  2. Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Final Height

    Time frame · Baseline, when final height was reached (assessed up to Year 11)

    Registry description

    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.

  3. Change From Baseline in Weight Standard Deviation Score (SDS) at Final Height

    Time frame · Baseline, when final height was reached (assessed up to Year 11)

    Registry description

    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.

  4. Puberty Stage at Final Height

    Time frame · When final height was reached (assessed up to Year 11)

    Registry description

    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.

Secondary outcomes(20)

  1. Bone Age

    Time frame · Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

    Registry description

    Bone age was determined by the Greulich and Pyle method using left wrist and hand X-ray.

  2. Lean Body Mass

    Time frame · Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

    Registry description

    Lean body mass, a measurement of body composition, was assessed by Dual Energy X-ray Absorptiometry (DEXA) scan.

  3. Annual Percent Change in Lean Body Mass at Year 1, 2 and 3

    Time frame · Baseline, Year 1, 2, 3

    Registry description

    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.

  4. Percent Change From Baseline in Lean Body Mass at Year 3

    Time frame · Baseline, Year 3

    Registry description

    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.

  5. Lean Body Mass as Percentage of Total Weight

    Time frame · Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

    Registry description

    Lean body mass, a measurement of body composition, was assessed by DEXA scan.

  6. Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA)

    Time frame · Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

    Registry description

    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.

  7. Fat Mass

    Time frame · Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

    Registry description

    Fat mass, a measurement of body composition, was assessed by DEXA scan.

  8. Annual Percent Change in Fat Mass at Year 1, 2 and 3

    Time frame · Baseline, Year 1, 2, 3

    Registry description

    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.

  9. Percent Change From Baseline in Fat Mass at Year 3

    Time frame · Baseline, Year 3

    Registry description

    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.

  10. Fat Mass as Percentage of Total Weight

    Time frame · Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

    Registry description

    Fat mass, a measurement of body composition, was assessed by DEXA scan.

  11. Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA)

    Time frame · Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

    Registry description

    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.

  12. Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS])

    Time frame · Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

    Registry description

    BMAD (LS) was assessed by DEXA scan.

  13. Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA])

    Time frame · Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

    Registry description

    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.

  14. Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage])

    Time frame · Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

    Registry description

    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.

  15. Bone Mineral Density of Total Body (BMD [TB])

    Time frame · Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

    Registry description

    BMD (TB) was assessed by DEXA scan.

  16. Bone Mineral Density of Lumbar Spine (BMD [LS])

    Time frame · Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

    Registry description

    BMD (LS) was assessed by DEXA scan.

  17. Bone Mineral Content of Total Body (BMC [TB])

    Time frame · Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

    Registry description

    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.

  18. Annual Percent Change in Bone Mineral Content of Total Body (BMC [TB]) at Year 1, 2 and 3

    Time frame · Baseline, Year 1, 2, 3

    Registry description

    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.

  19. Percent Change From Baseline in Bone Mineral Content of Total Body (BMC [TB]) at Year 3

    Time frame · Baseline, Year 3

    Registry description

    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.

  20. Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA])

    Time frame · Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Baseline, Year 3

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

GroupValue (Standard Deviation Score (SDS))
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)-3.6
Somatropin- Up To Year 3 (Nephrotic Syndrome)-2.5
Primary outcomeMedian· Baseline, when final height was reached (assessed up to Year 11)

Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Final Height

GroupValue (SDS)
Somatropin- After Year 3-2.86
Primary outcomeMedian· Baseline, when final height was reached (assessed up to Year 11)

Change From Baseline in Weight Standard Deviation Score (SDS) at Final Height

GroupValue (SDS)
Somatropin- After Year 3-1.53
Primary outcomeNumber· When final height was reached (assessed up to Year 11)

Puberty Stage at Final Height

GroupValue (participants)
Somatropin- After Year 30
Secondary and other outcome results(4)
Secondary outcomeMedian· Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Bone Age

GroupValue (years)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)8.9
Somatropin- Up To Year 3 (Nephrotic Syndrome)10.5
Secondary outcomeMedian· Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Lean Body Mass

GroupValue (kilogram (kg))
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)17.69
Somatropin- Up To Year 3 (Nephrotic Syndrome)23.56
Secondary outcomeMedian· Baseline, Year 1, 2, 3

Annual Percent Change in Lean Body Mass at Year 1, 2 and 3

GroupValue (percent change)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)18.95
Somatropin- Up To Year 3 (Nephrotic Syndrome)22.97
Secondary outcomeMedian· Baseline, Year 3

Percent Change From Baseline in Lean Body Mass at Year 3

GroupValue (percent change)
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)36.82
Somatropin- Up To Year 3 (Nephrotic Syndrome)54.44

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.–13 / 1513 / 15
Somatropin- Up To Year 3 (Nephrotic Syndrome)Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.–14 / 1514 / 15
Somatropin- After Year 3Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.–19 / 2121 / 21

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedDavid H, Aupiais C, Louveau B, Quartier P, Jacqz-Aigrain E, Carel JC, Simon D. Growth Outcomes After GH Therapy of Patients Given Long-Term Corticosteroids for Juvenile Idiopathic Arthritis. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4578-4587. doi: 10.1210/jc.2017-01455. PMID 29029101

Eligibility

Who could join, as posted.

Sex
All
Age
from 11 Years up to 17 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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