Endocrine System DiseasesPhase 3NCT00174187

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

A Phase 3 study testing Somatropin in people with Endocrine System Diseases, run by Pfizer at 2 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

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 Read more about this study

Who is it for?: Ages 11 to 17 years
Conditions the study is for: Endocrine System Diseases
What is being tested?: Somatropin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 2 sitesFrance
Study dates: Sep 2000to Sep 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 11 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Children with juvenile arthritis or nephrotic syndrome
Before or during puberty

Who cannot join

Diabetes Type 1 and 2
Endocrine disease, except well substituted hypothyroidism

Trial locations and contacts

2 sites in 1 country.

France2 sites

Pfizer Investigational Site
Paris, 75019
Pfizer Investigational Site
Paris, 75743

Other trials in France

About this study

Official title: 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

Read the detailed description

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.

Conditions: Endocrine System Diseases
Being tested: Somatropin
Medical subject headings: Endocrine System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SomatropinDrug
liquid, daily, until final height Dosage: 0,46 mg/kg/week . The maximum dose should not exceed 50 µg/Kg/day

Study groups in NCT00174187
Study group	Role	What they receive
Somatropin	Experimental	Not described Receives: Drug: Somatropin

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at 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.
Measured: Baseline, Year 3
Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Final Height
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.
Measured: Baseline, when final height was reached (assessed up to Year 11)
Change From Baseline in Weight Standard Deviation Score (SDS) at Final Height
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.
Measured: Baseline, when final height was reached (assessed up to Year 11)
Puberty Stage at Final Height
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.
Measured: When final height was reached (assessed up to Year 11)

Secondary outcomes (21)

Bone Age
Bone age was determined by the Greulich and Pyle method using left wrist and hand X-ray.
Measured: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Lean Body Mass
Lean body mass, a measurement of body composition, was assessed by Dual Energy X-ray Absorptiometry (DEXA) scan.
Measured: 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
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.
Measured: Baseline, Year 1, 2, 3
Percent Change From Baseline in Lean Body Mass at 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.
Measured: Baseline, Year 3
Lean Body Mass as Percentage of Total Weight
Lean body mass, a measurement of body composition, was assessed by DEXA scan.
Measured: 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)
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.
Measured: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Fat Mass
Fat mass, a measurement of body composition, was assessed by DEXA scan.
Measured: 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
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.
Measured: Baseline, Year 1, 2, 3
Percent Change From Baseline in Fat Mass at 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.
Measured: Baseline, Year 3
Fat Mass as Percentage of Total Weight
Fat mass, a measurement of body composition, was assessed by DEXA scan.
Measured: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA)
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.
Measured: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS])
BMAD (LS) was assessed by DEXA scan.
Measured: 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])
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.
Measured: 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])
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.
Measured: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Bone Mineral Density of Total Body (BMD [TB])
BMD (TB) was assessed by DEXA scan.
Measured: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Bone Mineral Density of Lumbar Spine (BMD [LS])
BMD (LS) was assessed by DEXA scan.
Measured: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Bone Mineral Content of Total Body (BMC [TB])
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.
Measured: 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
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.
Measured: Baseline, Year 1, 2, 3
Percent Change From Baseline in Bone Mineral Content of Total Body (BMC [TB]) at 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.
Measured: Baseline, Year 3
Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA])
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.
Measured: 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])
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.
Measured: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2000Sep 2011

First posted15 Sep 2005 (estimated)
Study startSep 2000
Primary completionSep 2011
Study completionSep 2011

Why it stopped: See termination reason in detailed description.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Endocrine System DiseasesStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00174187
Sponsor's protocol ID: 307-MET-9002-0009
Other IDs: A6281016
Status last verified: Nov 2012
First submitted: 9 Sep 2005
Last updated: 4 Dec 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

David 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.
PubMed 29029101

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT00174187
Acronym / sponsor ID: 307-MET-9002-0009
Conditions: Endocrine System Diseases
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: See termination reason in detailed description.
Enrolment: 30 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2000
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 15 Sep 2005 (estimated)
Results: Posted 4 Dec 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Somatropin	Experimental	Drug: Somatropin

Who may qualify

Ages: 11 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Children with juvenile arthritis or nephrotic syndrome
Before or during puberty

Key exclusion criteria (2 listed)

Diabetes Type 1 and 2
Endocrine disease, except well substituted hypothyroidism

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Somatropinliquid, daily, until final height Dosage: 0,46 mg/kg/week . The maximum dose should not exceed 50 µg/Kg/day	Drug	Somatropin

Primary outcome

Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3
Time frame: 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.
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)
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.
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)
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.
Puberty Stage at Final Height
Time frame: 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.

21 secondary outcomes

Bone Age
Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Lean Body Mass
Time frame: 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
Time frame: Baseline, Year 1, 2, 3
Percent Change From Baseline in Lean Body Mass at Year 3
Time frame: Baseline, Year 3
Lean Body Mass as Percentage of Total Weight
Time frame: 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)
Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Fat Mass
Time frame: 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
Time frame: Baseline, Year 1, 2, 3
Percent Change From Baseline in Fat Mass at Year 3
Time frame: Baseline, Year 3
Fat Mass as Percentage of Total Weight
Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 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
Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS])
Time frame: 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])
Time frame: 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])
Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Bone Mineral Density of Total Body (BMD [TB])
Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Bone Mineral Density of Lumbar Spine (BMD [LS])
Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Bone Mineral Content of Total Body (BMC [TB])
Time frame: 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
Time frame: Baseline, Year 1, 2, 3
Percent Change From Baseline in Bone Mineral Content of Total Body (BMC [TB]) at Year 3
Time frame: Baseline, Year 3
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
Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage])
Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Results and safety

Results posted to the registry on 4 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)	15	15
Somatropin- Up To Year 3 (Nephrotic Syndrome)	15	11
Somatropin- After Year 3	0	0

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

Time frame: Baseline, Year 3. Median (Inter-Quartile Range). Unit: Standard Deviation Score (SDS)

Measure	Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis) n = 15	Somatropin- Up To Year 3 (Nephrotic Syndrome) n = 15
Baseline	-3.6 (-5.1 to -2.3)	-2.5 (-2.8 to -2.2)
Change at Year 3	0.2 (-1.5 to 1.8)	1.1 (0.8 to 1.5)

Population analysed: Full Analysis Set (FAS) up to Year 3: included all participants who had at least 1 post-baseline height measurement and were treated with the study drug for at least 1 year.

Primary outcome: 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). Median (Full Range). Unit: SDS

Measure	Somatropin- After Year 3 n = 21
Baseline (n = 21)	-2.86 (-5.61 to -1.00)
Change at Final Height (n = 4)	0.71 (0.27 to 3.08)

Population analysed: FAS- after Year 3: included all participants who received at least 1 dose of the study treatment and who had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points.

Primary outcome: 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). Median (Full Range). Unit: SDS

Measure	Somatropin- After Year 3 n = 21
Baseline (n = 21)	-1.53 (-4.77 to 2.64)
Change at Final Height (n = 4)	-0.43 (-1.37 to 1.09)

Population analysed: FAS- after Year 3: included all participants who received at least one dose of the study treatment and who had at least one post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time point.

Primary outcome: Puberty Stage at Final Height

Time frame: When final height was reached (assessed up to Year 11). Number. Unit: participants

Measure	Somatropin- After Year 3 n = 4
Pubic hair: Stage I (n=4)	0
Pubic hair: Stage II (n=4)	0
Pubic hair: Stage III (n=4)	0
Pubic hair: Stage IV (n=4)	0
Pubic hair: Stage V (n=4)	4
Breast development: Stage I (n=1)	0
Breast development: Stage II (n=1)	0
Breast development: Stage III (n=1)	0

Population analysed: FAS- after Year 3: included all participants who received at least one dose of study treatment and who had at least one post-baseline height measurement. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants who were evaluable for given components of puberty assessment.

21 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)	13 of 15 (86.7%)	13 of 15 (86.7%)	Not reported
Somatropin- Up To Year 3 (Nephrotic Syndrome)	14 of 15 (93.3%)	14 of 15 (93.3%)	Not reported
Somatropin- After Year 3	19 of 21 (90.5%)	21 of 21 (100%)	Not reported

Limitations and caveats (from the sponsor): Results for secondary and other pre-specified endpoints (except IGF-1) are reported for only up to 3 years because data beyond Year 3 was not summarized as the study was terminated due to Good Clinical Practice (GCP) non-compliance issues.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29029101David 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Somatropin in people with Endocrine System Diseases, run by Pfizer at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3 (time frame: Baseline, Year 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00174187, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2012.