Short StatureNCT01970800
The Role of Igf-1 Generation Test in Diagnosis and Treatment of Short Stature
A study testing Growth Hormone in people with Short Stature, run by Maimonides Medical Center at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the predictive value of IGF-1 generation test for growth velocity during GH treatment for 12 months. Read more about this study
- Who is it for?
- Ages 5 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Short Stature
- What is being tested?
- Growth Hormone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Dec 2014
- Phase
- Interventional
- 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 5 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ability to provide written informed consent
- Prepubertal males and females form 5- 11years old
- Bone age <11 years in males and <9 years in females
- Height SD score<-2.25SD in males and females
- IGF-1SD score <-1SD in both males and females
- Peak GH level after stimulation >10ng/ml
Who cannot join
- History of prior chemotherapy and or radiation
- Active neoplasm
- Pediatric patients with closed epiphyses
- Prader-Willi syndrome, Turner syndrome or any other genetic or chromosomal anomaly
- Treatment with inhaled or systemic steroids
- BMI <5th percentile or >95th percentile
- Tanner 2 at clinical or biochemical examination by ultrasensitive LH and FSH
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to evaluate the predictive value of IGF-1 generation test for growth velocity during GH treatment for 12 months.
- Conditions
- Short Stature
- Being tested
- Growth Hormone
- Keywords
- IGF-1, Short Stature, GH
- Medical subject headings
- Dwarfism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth HormoneDrug
Also called Nutropin AQ
Will obtain daily injections and will evaluate the IGF-1 and IGFBP3 every 3 months
| Study group | Role | What they receive |
|---|---|---|
| Growth hormone, injections | Experimental | Growth hormone injection 0.3mg/kg/week dailY Receives: Drug: Growth Hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Outcome measurement
Growth velocity after treatment with appropriate growth hormone doses
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Nature of study was changed from ACT to retrospective chart review
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study was changed to a retrospective chart review. There was no prospective component.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimonides Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Svetlana Ten, MD, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970800
- Sponsor's protocol ID
- 10/01/VA03
- Status last verified
- Aug 2018
- First submitted
- 23 Oct 2013
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Igf-1 Generation Test in Diagnosis and Treatment of Short Stature
- ClinicalTrials.gov ID
- NCT01970800
- Acronym / sponsor ID
- 10/01/VA03
- Conditions
- Short Stature
- Keywords
- IGF-1, Short Stature, GH
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Nature of study was changed from ACT to retrospective chart review
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maimonides Medical CenterUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Oct 2013 (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.
The purpose of the study is to evaluate the predictive value of IGF-1 generation test for growth velocity during GH treatment for 12 months.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study was changed to a retrospective chart review. There was no prospective component.
| Arm | Type | Receives |
|---|---|---|
| Growth hormone, injections | Experimental | Drug: Growth HormoneGrowth hormone injection 0.3mg/kg/week dailY |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- ability to provide written informed consent
- Prepubertal males and females form 5- 11years old
- Bone age <11 years in males and <9 years in females
- Height SD score<-2.25SD in males and females
- IGF-1SD score <-1SD in both males and females
Key exclusion criteria (7 listed)
- History of prior chemotherapy and or radiation
- Active neoplasm
- Pediatric patients with closed epiphyses
- Prader-Willi syndrome, Turner syndrome or any other genetic or chromosomal anomaly
- Treatment with inhaled or systemic steroids
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 |
|---|---|---|
| Growth HormoneAlso: Nutropin AQWill obtain daily injections and will evaluate the IGF-1 and IGFBP3 every 3 months | Drug | Growth hormone, injections |
Primary outcome
Primary Efficacy Outcome measurement
Time frame: one year
Growth velocity after treatment with appropriate growth hormone doses
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
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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.
Svetlana Ten, MD principal investigator
Maimonides Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Growth Hormone in people with Short Stature, run by Maimonides Medical Center at 1 site in United States.
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 6 inclusion and 7 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: withdrawn, as of the sponsor's last update on 17 Aug 2018. 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 United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Primary Efficacy Outcome measurement (time frame: one year). 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 17 Aug 2018.