First-Voided Urinary LH vs. GnRH-stimulation in Differentiating Slowly- From Rapidly Progressive-Precocious Puberty

Summary

Precocious puberty (PP) in girls is classically defined by the onset of secondary sexual characteristics before eight years of age, but subsequent pubertal maturation can be quite varied. In many girls, PP takes a rapid course of progression (rapidly progressive precocious puberty; RP-PP) with an early menarche and fusion of the epiphyseal growth plates, leading eventually to a reduced final height if not treated. In a subset of girls with PP however, the growth rate slows to normal for age, skeletal maturation progresses in accordance with chronological age and there is little to no risk of impairment of final height (slowly progressive precocious puberty; SP-PP). Other conditions of non-progressive PP include premature breast budding and unsustained PP that is characterized by a spontaneous regression of sexual precocity. Due to their benign course, slowly progressive (SP) PP and other non-progressive forms of PP do not warrant therapy with GnRH agonists. Differentiating these forms from RP-PP is therefore essential to prevent unnecessary intervention in a population that accounts for at least 50% of girls with PP. A distinction between these forms of PP may be difficult on clinical grounds however, since all these patients may present initially as isolated breast development.

The gold standard for the diagnosis of true (central) PP is the measurement of gonadotropins following GnRH stimulation test. There is however an overlap between prepubertal and early pubertal values and between girls with premature breast budding and progressive PP. It was suggested therefore that progressive pubertal development and growth acceleration should be documented over a 3- to 6-months period before GnRHa therapy in initiated.

More than a decade ago several studies demonstrated that urinary gonadotropins are age related and significantly increased during puberty. It has been suggested that urinary gonadotropins measurements can be used for differential diagnosis of pubertal disorders. This is based on the assumption that gradual elevation of nocturnal LH secretion prior to and at the onset of puberty can be reflected by first-voided urinary LH (ULH). In this prospective study, the investigators aimed to evaluate the value of first-voided ULH measurements in predicting pubertal course and differentiating SP-PP from RP-PP, by comparison to GnRH-stimulated gonadotropins.

Conditions

• Precocious Puberty, Gonadotropin-dependent

Interventions

OTHER

Measurement of LH in first-voided urine

participants in this study will be studied by the standard GnRH stimulation test. In addition, they will provide first voided urine sample (the experimental part)for the measurement of LH.

OTHER

collection of first-voided urine sample for LH level

participants in this study will be studied by the standard GnRH stimulation test. In addition, they will provide first voided urine sample (the experimental part)for the measurement of LH.

Sponsors & Collaborators

• Amnon Zung

  lead OTHER

Principal Investigators

• Amnon Zung, MD · Pediatirc Endocrinology Unit, Kaplan Medical Center, affiliated with the Hebrew University of Jerusalem, Israel

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

3 Years

Max Age

9 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-06-30

Primary Completion

2013-12-31

Completion

2013-12-31

Countries

• Israel

Study Locations