Idiopathic Short StaturePhase 4ZomaTripNCT00840944
A 4 Year Combination Therapy of Growth Hormone and (GnRH) Agonist in Children With a Short Predicted Height
A Phase 4 study testing somatropin and triptorelin in people with Idiopathic Short Stature, run by Belgian Study Group for Pediatric Endocrinology at 6 sites in Belgium.
Trial summary
Estrogens are responsible for the disappearance of growth cartilage in the long bones at the end of the pubertal growth spurt both in boys and in girls. It is therefore hypothesized that stopping pubertal development and hence estrogen production, will prolong and increase the pubertal growth spurt, especially when… Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Idiopathic Short Stature
- What is being tested?
- somatropin and triptorelin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 6 sitesBelgium
- Study dates
- Jan 2008to Apr 2024
- 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 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adult height prediction below -2.5 SD : 151 cm for girls and 164 cm for boys based on the vlaamse groeicurve 2004 (vub.ac.be/groeicurven)
- Pubertal: breast development at least M2 for girls and at least 4 ml of testicular volume for boys
- Bone age >10 years but < 12 years for girls and > 11 but < 13 years for boys
- Signed informed consent
Who cannot join
- Adopted children ( different genetic background, lack of data on birth parameters and parents)
- Bone dysplasia or sitting height/ total height > 2 SDS on standards by Gerver et al (see appendix)
- Chronic use of glucocorticoids
- Previous growth promoting therapy such as GH, sex steroids, oxandrolone,
- Known GH deficiency
- Chronic infectious disease
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- Active rheumatic disease
- Previously diagnosed or currently suspected malignancy
- Sex steroid therapy
- Diabetes mellitus
- Renal insufficiency (serum creatinine > 1.5 mg/dl)
- Hepatic disease ( liver test > 4 fold upper limit of normality)
- Current congestive heart failure
- Inability to follow the study protocol
- Treatment with a non registered drug during the last 30 days before the moment of inclusion.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Belgium6 sites
Hopital Universitaire Reine Fabiola (HUDERF)
Brussels, 1050
Kinderziekenhuis UZ Brussel
Brussels, 1090
Antwerp University Hospital
Edegem, Antwerpen, 2650
Kinderziekenhuis UGent
Ghent, Oost Vlaanderen, 9000
Jessah Ziekenhuis
Hasselt, Limburg, 3000
CHU ND-des Bruyères
Liège, 4030
About this study
Official title: Efficacy and Safety of a 4 Year Combination Therapy of Growth Hormone and Gonadotropin- Releasing Hormone Agonist in Children With a Short Predicted Height.
Estrogens are responsible for the disappearance of growth cartilage in the long bones at the end of the pubertal growth spurt both in boys and in girls. It is therefore hypothesized that stopping pubertal development and hence estrogen production, will prolong and increase the pubertal growth spurt, especially when growth hormone is given concommitantly.
Boys in early puberty, with a bone age between 11 and 13 years and a predicted adult height below 163 cm or girls in early puberty with a bone age between 10 and 12 years and a predicted height under 151 cm will be treated with triptorelin 3.75 mg and Zomacton growth hormone for 4 years.
- Conditions
- Idiopathic Short Stature
- Being tested
- somatropin, triptorelin
- Keywords
- gonadotropin releasing hormone agonist, growth hormone, final height, bone density, puberty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatropinDrug
Also called growth hormone, zomacton
somatropin 0.050 mg/kg/day
triptorelinDrug
Also called decapeptyl
triptorelin 3.75 mg each month
| Study group | Role | What they receive |
|---|---|---|
| ZOMATRIP | Experimental | GnRH agonist triptorelin plus somatropin Receives: Drug: somatropin; Drug: triptorelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
height
Difference between predicted height at start of treatment and adult height
Measured: 6 - 8 years
Secondary outcomes (1)
bone density
Bone density SDS measured by DEXA
Measured: 6 - 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startJan 2008
- Primary completionJan 2024 (estimated)
- Study completionApr 2024 (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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belgian Study Group for Pediatric Endocrinology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilde Dotremont, Belgian Study Group for Pediatric Endocrinology
- Investigators
- Hilde Dotremont, MD, Principal investigator, BSGPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840944
- Sponsor's protocol ID
- EUDRACT 2007-003247-70
- Acronym
- ZomaTrip
- Status last verified
- Jul 2023
- First submitted
- 10 Feb 2009
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Dotremont H, France A, Heinrichs C, Tenoutasse S, Brachet C, Cools M, De Waele K, Massa G, Lebrethon MC, Gies I, Van Besien J, Derycke C, Ziraldo M, De Schepper J, Beauloye V, Verhulst S, Rooman R, den Brinker M. Efficacy and safety of a 4-year combination therapy of growth hormone and gonadotropin-releasing hormone analogue in pubertal girls with short predicted adult height. Front Endocrinol (Lausanne). 2023 Mar 17;14:1113750. doi: 10.3389/fendo.2023.1113750. eCollection 2023.
PubMed 37008942
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a 4 Year Combination Therapy of Growth Hormone and Gonadotropin- Releasing Hormone Agonist in Children With a Short Predicted Height.
- ClinicalTrials.gov ID
- NCT00840944
- Acronym / sponsor ID
- ZomaTrip / EUDRACT 2007-003247-70
- Conditions
- Idiopathic Short Stature
- Keywords
- gonadotropin releasing hormone agonist, growth hormone, final height, bone density, puberty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Belgian Study Group for Pediatric EndocrinologyUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 11 Feb 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.
Estrogens are responsible for the disappearance of growth cartilage in the long bones at the end of the pubertal growth spurt both in boys and in girls. It is therefore hypothesized that stopping pubertal development and hence estrogen production, will prolong and increase the pubertal growth spurt, especially when growth hormone is given concommitantly.
Boys in early puberty, with a bone age between 11 and 13 years and a predicted adult height below 163 cm or girls in early puberty with a bone age between 10 and 12 years and a predicted height under 151 cm will be treated with triptorelin 3.75 mg and Zomacton growth hormone for 4 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZOMATRIP | Experimental | Drug: somatropin, Drug: triptorelinGnRH agonist triptorelin plus somatropin |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Adult height prediction below -2.5 SD : 151 cm for girls and 164 cm for boys based on the vlaamse groeicurve 2004 (vub.ac.be/groeicurven)
- Pubertal: breast development at least M2 for girls and at least 4 ml of testicular volume for boys
- Bone age >10 years but < 12 years for girls and > 11 but < 13 years for boys
- Signed informed consent
Key exclusion criteria (15 listed)
- Adopted children ( different genetic background, lack of data on birth parameters and parents)
- Bone dysplasia or sitting height/ total height > 2 SDS on standards by Gerver et al (see appendix)
- Chronic use of glucocorticoids
- Previous growth promoting therapy such as GH, sex steroids, oxandrolone,
- Known GH deficiency
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 |
|---|---|---|
| somatropinAlso: growth hormone, zomactonsomatropin 0.050 mg/kg/day | Drug | ZOMATRIP |
| triptorelinAlso: decapeptyltriptorelin 3.75 mg each month | Drug | ZOMATRIP |
Primary outcome
height
Time frame: 6 - 8 years
Difference between predicted height at start of treatment and adult height
1 secondary outcome
bone density
Time frame: 6 - 8 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Derived from this study: PubMed 37008942Dotremont H, France A, Heinrichs C, Tenoutasse S, Brachet C, Cools M, De Waele K, Massa G, Lebrethon MC, Gies I, Van Besien J, Derycke C, Ziraldo M, De Schepper J, Beauloye V, Verhulst S, Rooman R, den Brinker M. Efficacy and safety of a 4-year combination therapy of growth hormone and gonadotropin-releasing hormone analogue in pubertal girls with short predicted adult height. Front Endocrinol (Lausanne). 2023 Mar 17;14:1113750. doi: 10.3389/fendo.2023.1113750. eCollection 2023.
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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.
Hilde Dotremont, MD principal investigator
BSGPE
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing somatropin and triptorelin in people with Idiopathic Short Stature, run by Belgian Study Group for Pediatric Endocrinology at 6 sites in Belgium.
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 4 inclusion and 15 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 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium. 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?
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?
height (time frame: 6 - 8 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 NCT00840944, 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 28 Jul 2023.