Growth Hormone TreatmentNCT00867971
Is Recombinant Growth Hormone Therapy Associated With Increased Intraoccular Pressure?
An observational study of Growth Hormone Treatment and Glaucoma, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Recombinant growth hormone is a common therapy in the pediatric population. A number of associated side effects have been described. Several years ago, a case report was published concerning a child that was treated with RGH and developed acute glaucoma. To date no study has evaluated the connection. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Growth Hormone Treatment, Glaucoma
- What is being tested?
- Measuring intraoccular pressure
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2009to Oct 2010
- Phase
- Observational
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children age 6-18 treated with growth hormone
Who may be able to join
- Age 6-18 years
- treatment with recombinant growth hormone
Who cannot join
- Underlying Chronic diseases
- Family history of eye diseases
- elevated occular pressure prior to starting treatment
Trial locations and contacts
1 site in 1 country.
About this study
Recombinant growth hormone is a common therapy in the pediatric population. A number of associated side effects have been described. Several years ago, a case report was published concerning a child that was treated with RGH and developed acute glaucoma. To date no study has evaluated the connection.
- Conditions
- Growth Hormone Treatment, Glaucoma
- Being tested
- Measuring intraoccular pressure
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring intraoccular pressureOther
Measurement of intraoccular pressure by tonometry
| Study group | Role | What they receive |
|---|---|---|
| RGH treated | Not described Receives: Other: Measuring intraoccular pressure | |
| Starting treatment with RGH | Not described Receives: Other: Measuring intraoccular pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoccular pressure in children treated with RGH
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionOct 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth Hormone TreatmentStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867971
- Sponsor's protocol ID
- 162/08
- Status last verified
- Feb 2009
- First submitted
- 22 Mar 2009
- Last updated
- 24 Mar 2009
- Results posted
- No
Publications
Youngster I, Rachmiel R, Pinhas-Hamiel O, Bistritzer T, Zuckerman-Levin N, de Vries L, Naugolny L, Eyal O, Braunstein R, Rachmiel M. Treatment with recombinant human growth hormone during childhood is associated with increased intraocular pressure. J Pediatr. 2012 Dec;161(6):1116-9. doi: 10.1016/j.jpeds.2012.05.024. Epub 2012 Jun 23.
PubMed 22727870
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Recombinant Growth Hormone Therapy Associated With Increased Intraoccular Pressure?
- ClinicalTrials.gov ID
- NCT00867971
- Acronym / sponsor ID
- 162/08
- Conditions
- Growth Hormone Treatment, Glaucoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Feb 2009
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 24 Mar 2009 (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.
Recombinant growth hormone is a common therapy in the pediatric population. A number of associated side effects have been described. Several years ago, a case report was published concerning a child that was treated with RGH and developed acute glaucoma. To date no study has evaluated the connection.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RGH treated | – | Other: Measuring intraoccular pressure |
| Starting treatment with RGH | – | Other: Measuring intraoccular pressure |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children age 6-18 treated with growth hormone
Key inclusion criteria (2 listed)
- Age 6-18 years
- treatment with recombinant growth hormone
Key exclusion criteria (3 listed)
- Underlying Chronic diseases
- Family history of eye diseases
- elevated occular pressure prior to starting treatment
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 |
|---|---|---|
| Measuring intraoccular pressureMeasurement of intraoccular pressure by tonometry | Other | RGH treated, Starting treatment with RGH |
Primary outcome
Intraoccular pressure in children treated with RGH
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2009.
- Derived from this study: PubMed 22727870Youngster I, Rachmiel R, Pinhas-Hamiel O, Bistritzer T, Zuckerman-Levin N, de Vries L, Naugolny L, Eyal O, Braunstein R, Rachmiel M. Treatment with recombinant human growth hormone during childhood is associated with increased intraocular pressure. J Pediatr. 2012 Dec;161(6):1116-9. doi: 10.1016/j.jpeds.2012.05.024. Epub 2012 Jun 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Treatment and Glaucoma, run by Assaf-Harofeh 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Mar 2009. 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.
Are results available for this study?
Results are not available in the source record.
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?
Intraoccular pressure in children treated with RGH (time frame: 2 years). 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 NCT00867971, 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 24 Mar 2009.