MedTrace Logo

Aromatase Inhibitor in Bone Maturation, Children With Silver Russell or Prader-Willi Syndrome

NCT01520467 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2016-08-24

No results posted yet for this study

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 in bone maturation and premature epiphyseal fusion. Aromatase inhibitors, used for the treatment of hormone-dependent cancers, block the transformation of androgens into estrogens. Third generation inhibitors, of which Anastrozole is one, appear to be well tolerated in children and are sometimes used within the framework of clinical trials to limit bone maturation and improve prognosis with respect to final size, notably in children treated with growth hormone (GH) due to a GH deficit. Nevertheless, the data reported are based on small sample sizes and do not include children with pathological adrenarche.

Conditions

Interventions

DRUG

Anastrozole

Anastrozole (1mg/day), administered orally for 18 months

DRUG

Placebo

1 placebo tablet /day administered orally for 18 months.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Irène Netchine, MD, PhD · Assistance Publique

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2016-07-31
Completion
2016-10-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01520467 on ClinicalTrials.gov