Idiopathic Short StaturePhase 4ISSNCT00458263
Biochemical Markers of Growth Response to Growth Hormone Treatment in Children With Idiopathic Short Stature
A Phase 4 study testing Somatotropin growth hormone recombinant human in people with Idiopathic Short Stature, run by Rabin Medical Center at 1 site in Israel.
Trial summary
One arm, open, prospective, intervention study to assess biochemical markers of growth response to Growth Hormone treatment in 20 Children, aged 3-9 years old, with idiopathic short stature. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Idiopathic Short Stature
- What is being tested?
- Somatotropin growth hormone recombinant human
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2006to May 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 3 to <9 years
- Short stature with height >2.25 Standard Deviation below the mean
- Prepubertal (Tanner stage I) at commencement of trial
- Peak Growth Hormone above 10ng/ml in at least one provocative test for Growth Hormone secretion
- Signing informed consent forms
Who cannot join
- Intra Uterine Growth Retardation
- Growth retardation associated with malignancy, severe chronic disease, genetic syndromes and endocrine disorders
- Diabetes
- Treatment with any medical product which may interfere with Growth Hormone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: One Arm, Open Study to Assess Biochemical Markers of Growth Response to Growth Hormone Treatment in Children With Idiopathic Short Stature
One arm, open, prospective, intervention study to assess biochemical markers of growth response to Growth Hormone treatment in 20 Children, aged 3-9 years old, with idiopathic short stature. All participants will be treated with Growth Hormone during the first year of the study (and then in accordance with the local ethic requirement, to supply drug which is not approved for the indication used in the study, for additional 3 years) and then will be followed up for the next 3 years. The impact of Growth Hormone therapy on clinical laboratory parameters that are indicative of the growth response will be assessed by collecting blood and urine samples during the 4 years study period. The primary endpoints are measurements of height and growth velocity during the year of Growth Hormone treatment, the height at the beginning of puberty and final height. Secondary endpoints are psychological parameters, assessed by questionnaires.
Read the detailed description
One arm, open prospective intervention study to assess biochemical markers of growth response to Growth Hormone treatment in 20 children, aged 3-9 years old, with idiopathic short stature.
Objectives:
- To determine axiological and biochemical markers for growth response
- To assess the period of time necessary to determine the parameters which will differentiate between responders and non-responders
Inclusion criteria:
- Ages 3 to <9 years
- Short stature with height >2.25 Standard Deviation below the mean
- Prepubertal (Tanner stage I) at commencement of trial
- Peak Growth Hormone above 10ng/ml in at least one provocative test for Growth Hormone secretion
- Signing Informed consent forms
Exclusion criteria:
- Intra Uterine Growth Retardation
- Growth retardation associated with malignancy, severe chronic disease, genetic syndromes and endocrine disorders
- Diabetes
- Treatment with any medical product which may interfere with Growth Hormone effects
Methods:
- All participants will be treated with Growth Hormone during the first year of the study (and then in accordance with the local ethic requirement, to supply drug which is not approved for the indication used in the study, for additional 3 years) and then will be followed up for the next 3 years.
- The impact of Growth Hormone therapy on clinical laboratory parameters that are indicative of the growth response will be assessed by collecting blood and urine samples during the 4 years study period.Samples will be test for biochemical markers of bone formation and resorption
- The primary endpoints are measurements of height and growth velocity during the year of Growth Hormone treatment, the height at the beginning of puberty and final height. Secondary endpoints are psychological parameters, assessed by questionnaires.
- Conditions
- Idiopathic Short Stature
- Being tested
- Somatotropin growth hormone recombinant human
- Keywords
- Growth Hormone treatment, ISS, Biochemical markers, Growth response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatotropin growth hormone recombinant humanDrug
daily Sub Cutaneous injections
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Not described Receives: Drug: Somatotropin growth hormone recombinant human |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height
Measured: every 4 months
Growth velocity
Measured: every 4 months
Height at beginning of puberty
Measured: At the biginning of puberty
Final height
Measured: When acheiving final height
Secondary outcomes (2)
Psychological parameters
Measured: once a year
HbA1c and IGF-1
Measured: at baseline. after 3 months and than every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2007 (estimated)
- Study startApr 2006
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Short StatureStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Moshe Phillip, Prof, MD, Principal investigator, Schneider Children Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458263
- Sponsor's protocol ID
- rmc003515ctil
- Acronym
- ISS
- Status last verified
- Oct 2011
- First submitted
- 8 Apr 2007
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Arm, Open Study to Assess Biochemical Markers of Growth Response to Growth Hormone Treatment in Children With Idiopathic Short Stature
- ClinicalTrials.gov ID
- NCT00458263
- Acronym / sponsor ID
- ISS / rmc003515ctil
- Conditions
- Idiopathic Short Stature
- Keywords
- Growth Hormone treatment, ISS, Biochemical markers, Growth response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Apr 2006
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 10 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One arm, open, prospective, intervention study to assess biochemical markers of growth response to Growth Hormone treatment in 20 Children, aged 3-9 years old, with idiopathic short stature. All participants will be treated with Growth Hormone during the first year of the study (and then in accordance with the local ethic requirement, to supply drug which is not approved for the indication used in the study, for additional 3 years) and then will be followed up for the next 3 years. The impact of Growth Hormone therapy on clinical laboratory parameters that are indicative of the growth response will be assessed by collecting blood and urine samples during the 4 years study period. The primary endpoints are measurements of height and growth velocity during the year of Growth Hormone treatment, the height at the beginning of puberty and final height. Secondary endpoints are psychological parameters, assessed by questionnaires.
Detailed description
One arm, open prospective intervention study to assess biochemical markers of growth response to Growth Hormone treatment in 20 children, aged 3-9 years old, with idiopathic short stature.
Objectives:
- To determine axiological and biochemical markers for growth response
- To assess the period of time necessary to determine the parameters which will differentiate between responders and non-responders
Inclusion criteria:
- Ages 3 to <9 years
- Short stature with height >2.25 Standard Deviation below the mean
- Prepubertal (Tanner stage I) at commencement of trial
- Peak Growth Hormone above 10ng/ml in at least one provocative test for Growth Hormone secretion
- Signing Informed consent forms
Exclusion criteria:
- Intra Uterine Growth Retardation
- Growth retardation associated with malignancy, severe chronic disease, genetic syndromes and endocrine disorders
- Diabetes
- Treatment with any medical product which may interfere with Growth Hormone effects
Methods:
- All participants will be treated with Growth Hormone during the first year of the study (and then in accordance with the local ethic requirement, to supply drug which is not approved for the indication used in the study, for additional 3 years) and then will be followed up for the next 3 years.
- The impact of Growth Hormone therapy on clinical laboratory parameters that are indicative of the growth response will be assessed by collecting blood and urine samples during the 4 years study period.Samples will be test for biochemical markers of bone formation and resorption
- The primary endpoints are measurements of height and growth velocity during the year of Growth Hormone treatment, the height at the beginning of puberty and final height. Secondary endpoints are psychological parameters, assessed by questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Drug: Somatotropin growth hormone recombinant human |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Ages 3 to <9 years
- Short stature with height >2.25 Standard Deviation below the mean
- Prepubertal (Tanner stage I) at commencement of trial
- Peak Growth Hormone above 10ng/ml in at least one provocative test for Growth Hormone secretion
- Signing informed consent forms
Key exclusion criteria (4 listed)
- Intra Uterine Growth Retardation
- Growth retardation associated with malignancy, severe chronic disease, genetic syndromes and endocrine disorders
- Diabetes
- Treatment with any medical product which may interfere with Growth Hormone
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 |
|---|---|---|
| Somatotropin growth hormone recombinant humandaily Sub Cutaneous injections | Drug | single arm |
Primary outcome
Height
Time frame: every 4 months
Growth velocity
Time frame: every 4 months
Height at beginning of puberty
Time frame: At the biginning of puberty
Final height
Time frame: When acheiving final height
2 secondary outcomes
Psychological parameters
Time frame: once a year
HbA1c and IGF-1
Time frame: at baseline. after 3 months and than every 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
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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.
Moshe Phillip, Prof, MD principal investigator
Schneider Children Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Somatotropin growth hormone recombinant human in people with Idiopathic Short Stature, run by Rabin Medical Center at 1 site in Israel.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Height (time frame: every 4 months). 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?
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 3 Jan 2013.