Overview
Sponsor-declared trial summary
Short predicted height
The primary objective of this study is to test the hypothesis that in boys with a low predicted adult height , adult height gain (height attained minus predicted height) is higher after a 4 year combination therapy with GH (Omnitrope ®) and the aromatase inhibitor (Letrozole®), started at the beginning of puberty, than…
Key facts
- Sponsor
- Universitair Ziekenhuis Antwerpen
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19]
- Decision date (initial)
- 2025-01-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519935-41-00
- EudraCT number
- 2011-002684-25
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy
The primary objective of this study is to test the hypothesis that in boys with a low predicted adult height , adult height gain (height attained minus predicted height) is higher after a 4 year combination therapy with GH (Omnitrope ®) and the aromatase inhibitor (Letrozole®), started at the beginning of puberty, than in patients that receive only GH.
Secondary objectives 1
- The study aims to evaluate differences in body composition, insulin sensitivity, and adult height outcomes between treatment groups after a 4-year period, while monitoring safety and identifying predictors of height gain, such as birth metrics and parental height. It also examines whether aggression levels, quality of life, bone mineral density, and gonadotropin levels differ between groups or change over the course of treatment.
Conditions and MedDRA coding
Short predicted height
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Male gender
- Adult height prediction below or equal to –2.5 SD : < 164.0 cm based on the Vlaamse groeicurve 2004 (vub.ac.be/groeicurven) using the Greulich and Pyle Bayley Pinneau prediction method
- Pubertal: at least 4 ml of testicular volume for boys
- Bone age ≥ 11 but ≤ 13 years for boys
- Signed informed consent
Exclusion criteria 16
- Children for whom data on birth length, weight and height of one of the parents are lacking
- Bone dysplasia or sitting height/ total height > 2 SDS on standards by Gerver et al (see appendix)
- Vertebral anomalies
- Chronic use of glucocorticoids
- Previous growth promoting therapy such as GH, sex steroids, oxandrolone, aromatase inhibitors
- Known GH deficiency
- Chronic infectious disease
- 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 90 days before the moment of inclusion.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Adult height gain = Final height minus predicted adult height
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Letrozole Fair-Med Healthcare 2.5 mg film coated tablets
PRD11044896 · Product
- Active substance
- Letrozole
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1.25 mg milligram(s)
- Max total dose
- 1.25 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BG04 — LETROZOLE
- Marketing authorisation
- PL 49565/0138
- MA holder
- RUDIPHARM LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Already commercially available.
Comparator 1
Omnitrope 10 mg/1.5 ml solution for injection in cartridge
PRD6059764 · Product
- Active substance
- Somatropin
- Substance synonyms
- RECOMBINANT HUMAN GROWTH HORMONE, SOMATOTROPHIN, CB-311, LY-137998
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 50 µg/Kg microgram(s)/kilogram
- Max total dose
- 2.70 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- H01AC01 — SOMATROPIN
- Marketing authorisation
- EU/1/06/332/009
- MA holder
- SANDOZ GMBH
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Already commercially available.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Ziekenhuis Antwerpen
- Sponsor organisation
- Universitair Ziekenhuis Antwerpen
- Address
- Drie Eikenstraat 655
- City
- Edegem
- Postcode
- 2650
- Country
- Belgium
Scientific contact point
- Organisation
- Universitair Ziekenhuis Antwerpen
- Contact name
- Universitair Ziekenhuis Antwerpen
Public contact point
- Organisation
- Universitair Ziekenhuis Antwerpen
- Contact name
- Universitair Ziekenhuis Antwerpen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Universitair Ziekenhuis Antwerpen ORG-100009995
|
Edegem, Belgium | Other |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 50 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EN 2024-519935-41-00 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Child DU | 1.5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Child FR | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Parents DU | 1.5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Parents FR | 1.4 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material Questionnaire Agression DU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material Questionnaire Lifestyle DU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material Questionnaire Lifestyle FR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material Questionnaire QoLISSY DU | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Letrozole DU | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Omnitrope DU | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-10 | Belgium | Acceptable 2025-01-10
|
2025-01-10 |