Efficacy and Safety of Somatropin in Combination with Leuprorelin Compared to Somatropin Alone and to an Untreated Control Group in Pubertal Children with Idiopathic Short Stature - PHOENIX
- Conditions
- Children with Idiopathic Short Stature (ISS) at puberty onset.MedDRA version: 8.1Level: LLTClassification code 10040600Term: Short stature
- Registration Number
- EUCTR2005-001750-25-NL
- Lead Sponsor
- ILLY FRANCE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 88
1.Male or female children with ISS defined as height = –2.5 SDS for age and gender (according to national references) or predicted adult height = –2.5 SDS at study entry based on the Bayley-Pinneau method, with a bone age reading by the central reader.
2.A chronological age = 8 years and < 12 years and 3 months for girls (before the 12th birthday), and = 9 years and < 14 years and 3 months for boys.
3.A bone age = 12.0 years for girls and = 14.0 years for boys based on a central reading of an X-ray of the left hand and wrist taken at the screening visit (V0).
4.Pubertal stage B2 and B3 for girls based on the Tanner method, as determined by clinical examination at the screening visit (V0).
5.Pubertal stage G2 and G3 for boys based on the Tanner method or a testicular length = 30 mm and < 40 mm or a testicular volume = 4 ml and < 12 ml, as determined by clinical examination at the screening visit (V0).
Are the trial subjects under 18? yes
Number of subjects for this age range:
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
1.Growth hormone deficiency (GHD) based on two GH stimulation tests performed in the 3 years before the screening visit resulting in both GH values = 20 mIU/L (depending on the conversion factor, usually: 10 ng/ml).
Note: one stimulation test with a GH peak value > 20 mIU/L (depending on the conversion factor, usually: 10 ng/ml) is sufficient to eliminate a GHD.
2.Chromosomal abnormality diagnosed locally on a karyotype. For girls, the karyotype, to eliminate a Turner syndrome, is mandatory.
3.Small for gestational age (SGA): defined as length and/or weight at birth < –2 SDS versus normal gestational age height and weight measurements (Usher and McLean standards). Patients will not be excluded due to an unknown birth weight or length.
4.Has reached menarche (had her first menstrual period).
7.Have been currently or previously treated with any drug that may directly influence growth, such as somatropin, growth hormone releasing hormone or GnRH agonists, anabolic steroids, or aromatase inhibitors. This includes the previous completion or withdrawal from this study or any other study investigating any of these treatments.
8.Have any significant concomitant disease that is likely to interfere with growth or with the study, or is a known contraindication to GH treatment (malignancy, intra-cranial tumor, chronic disease such as insulin-dependent diabetes mellitus, chronic infectious disease, chronic renal insufficiency, chronic heart failure, chronic hepatic disease, chronic pulmonary disease, active rheumatological disease, psychosis, neurofibromatosis, McCune Albright syndrome, dysmorphic syndromes such as Russell-Silver syndrome, Leri-Weill syndrome, achondroplasia, etc.) Hypothyroidism correctly substituted with thyroid hormone replacement treatment is not an exclusion criterion.
9.Have any known contraindication to GnRHa treatment (known hypersensitivity to GnRH, to GnRH agonists or to one of its ingredients) or presents genital bleeding of undetermined cause.
10.Receiving systemic or inhaled glucocorticoid therapy (more than ten days of treatment during the past three months) or receiving any other drug that is likely to directly interfere with growth (see classes of prohibited drugs in the appendix of protocol). A hypothyroidism correctly substituted with thyroid hormone replacement treatment is not an exclusion criterion.
11.Presenting with a lumbar spine BMD < –2 SDS (Z-score) assessed by DXA carried out at the screening visit and centrally assessed.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method