Status:
UNKNOWN
Aromatase Inhibitor in Bone Maturation, Children With Silver Russell or Prader-Willi Syndrome
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Silver Russell Syndrome
Prader-Willi Syndrome
Eligibility:
All Genders
5-12 years
Phase:
NA
Brief Summary
There is currently no drug with pediatric marketing authorization capable of limiting the advance in bone maturation of children with aggressive adrenarche. Estrogens are the principal actors involved...
Detailed Description
Silver-Russell syndrome (SRS), which occurs secondary to an imprinting disorder due to the anomalous methylation of chromosome 11 or due to a uniparental disomy of chromosome 7, is a rare syndrome (OR...
Eligibility Criteria
Inclusion
- Patients with genetically proven SRS or PWS, under treatment with GH in the usual context of the disease, presenting with adrenarche (defined either by DHEAS levels as a function of age or by the appearance of pubic hair) associated with a bone age at least 6 months greater than chronological age and in the absence of the onset of central puberty (LH peak ≤ LH peak in prepubertal patients, according to the standards of the laboratory performing the GnRH stimulation test for LH and FSH, and dating back to less than 3 months).
- Patients with medical coverage.
- The lower age limit for inclusion is 5 years and the upper age limit is 10 complete years for girls and 12 complete years for boys.
- The maximum body-mass index (BMI) Z-score for inclusion is +4
- Patients should be capable of swallowing pills of the same size as the experimental drug.
Exclusion
- Renal insufficiency (creatinine clearance, calculated according to the Schwartz formula, lower than 70ml/min/l, 73 m²),
- Hepatic insufficiency (prothrombin ratio \< 50% and factor V \< 50%),
- Hepatic cytolysis (liver transaminases levels greater than twice the normal level for age), cholestasis (gamma-glutamyl transferase (GGT) levels greater than twice the normal level for age),
- Contraindication to one of the components of Anastrozole or the placebo.
- Patients with scoliosis requiring surgery.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01520467
Start Date
April 1 2012
End Date
October 1 2016
Last Update
August 24 2016
Active Locations (1)
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1
Explorations Fonctionnelles d'Endocrinologie - Centre de Référence des Maladies Endocriniennes Rares de la Croissance Hôpital Armand Trousseau
Paris, France, 75012