Does a combination treatment with growth hormone and an aromatase inhibitor improve growth better than each therapy alone when applied for 4 years to boys in early puberty with a short predicted adult height The OMNIMARA Trial

Efficacy and safety of a 4 year pubertal therapy with growth hormone (somatropine Omnitrope) or an aromatase inhibitor (letrozole Femara) or the combination of both in boys with a short predicted height: The OMNIMARA Trial - OMNIMARA

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002684-25-BE

Enrollment

Registered

2012-03-14

Start date

2012-08-06

Completion date

Unknown

Last updated

2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

boys with idiopathic short adult stature defined as a predicted adult height below or equal to 164.0 cm ( -2.5 SDS) without a known cause MedDRA version: 20.0 Level: LLT Classification code 10066333 Term: Idiopathic short stature System Organ Class: 100000004859

Interventions

Trade Name: Omnitrope Product Name: somatropin Pharmaceutical Form: Solution for injection in cartridge INN or Proposed INN: SOMATROPIN CAS Number: 12629-01-5 Concentration unit: mg/ml milligram(s)/mi

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: o Male gender o 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 o Pubertal: at least 4 ml of testicular volume for boys o Bone age = 11 but = 13 years o Signed informed consent Are the trial subjects under 18? yes Number of subjects for this age range: 75 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: o Children for whom birth length, birth weigth, or parental height are not known o Bone dysplasia or sitting height/ total height > 2 SDS on standards by Gerver et al (see appendix) o Vertebral anomalies on spine X ray o Chronic use of glucocorticoids (including intranasal or intrabronchial glucocorticoid use for more than 90 days in the previous year) o Previous growth promoting therapy such as GH, sex steroids, oxandrolone, aromatase inhibitors o Known GH deficiency o Chronic infectious disease o Active rheumatic disease o Previously diagnosed or currently suspected malignancy o Sex steroid therapy o Diabetes mellitus o Renal insufficiency (serum creatinine > 1.5 mg/dl) o Hepatic disease ( liver test > 3 fold upper limit of normality) o Current congestive heart failure o Treatment with a non registered drug during the last 90 days before the moment of inclusion. o Inability or unwillingness to follow the protocol (measurements, questionnaire)

Design outcomes

Primary

Measure	Time frame
Primary end point(s): adult height gain defined as attained final height minus adult height predicted at the start of the trial;Timepoint(s) of evaluation of this end point: Adult height gain is determined when adult height is attained. Adult height is defined as the standing height attained at a bone age of 18.0 years or more in boys.;Main Objective: 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 (Femara ®), started at the beginning of puberty, than in patients that receive only GH or only letrozole.;Secondary Objective: To test for each treatment modality the hypothesis that adult height, attained after the 4 years of therapy, is different from the predicted adult height at the start of the study. To monitor the safety of the different treatment modalities To determine the predictors of adult height gain. the level of aggression during treatment is not different between the treatment groups. quality of life (Qolissy questionnaire) will improve in all treated groups from the start to the end of the treatment period. bone mineral density at final height is not different between the treatment groups bone geometry at final height is not different between the treatment groups. LH and FSH at final height are not different between the treatment groups. body composition is not different between the treatment groups insulin sensitivity at the end of the treatment period is not different between the treatment groups. To test that the response to letrozole is not dependent on the aromatase polymorphism	—

Measure

Time frame

Primary end point(s): adult height gain defined as attained final height minus adult height predicted at the start of the trial;Timepoint(s) of evaluation of this end point: Adult height gain is determined when adult height is attained. Adult height is defined as the standing height attained at a bone age of 18.0 years or more in boys.;Main Objective: 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 (Femara ®), started at the beginning of puberty, than in patients that receive only GH or only letrozole.;Secondary Objective: To test for each treatment modality the hypothesis that adult height, attained after the 4 years of therapy, is different from the predicted adult height at the start of the study. To monitor the safety of the different treatment modalities To determine the predictors of adult height gain. the level of aggression during treatment is not different between the treatment groups. quality of life (Qolissy questionnaire) will improve in all treated groups from the start to the end of the treatment period. bone mineral density at final height is not different between the treatment groups bone geometry at final height is not different between the treatment groups. LH and FSH at final height are not different between the treatment groups. body composition is not different between the treatment groups insulin sensitivity at the end of the treatment period is not different between the treatment groups. To test that the response to letrozole is not dependent on the aromatase polymorphism

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Secondary

Measure	Time frame
Secondary end point(s): 1. level of aggression by questionnaire 2. bone geometry 3.quality of life by questionnaire 4.insulin sensitivity 5.bone mineral density ;Timepoint(s) of evaluation of this end point: 1. questionnaire at start, 12 months, at the end of the treatment period ( 48 months) and 12 after the end of treatment 2. pQCT at start, 24 months, at end of treatment and at final height 3. questionnaire at start and at the end of treatment 4. at the end of the treatment period (48 months) 5.DEXA scan at start, end of treatment and at final height	—

Measure

Time frame

Secondary end point(s): 1. level of aggression by questionnaire 2. bone geometry 3.quality of life by questionnaire 4.insulin sensitivity 5.bone mineral density ;Timepoint(s) of evaluation of this end point: 1. questionnaire at start, 12 months, at the end of the treatment period ( 48 months) and 12 after the end of treatment 2. pQCT at start, 24 months, at end of treatment and at final height 3. questionnaire at start and at the end of treatment 4. at the end of the treatment period (48 months) 5.DEXA scan at start, end of treatment and at final height

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Countries

Belgium

Contacts

Public ContactProf Raoul Rooman

UZ Antwerpen Dept Pediatrics

raoul.rooman@uza.be323821 4009

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026