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The OMNIMARA Trial
EU CTIS ID: 2024-519935-41-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Children for whom data on birth length, weight and height of one of the parents are lacking
- 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
See the full eligibility criteria
- 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
- Children for whom data on birth length, weight and height of one of the parents are lacking
- 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.
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.