Aromatase inhibitors in girls: Anastrozole combined to the LHRH analogue leuprorelin in Girls with early or precocious puberty and a compromised growth potential

• Register: ISRCTN
• Last refreshed on: 29 April 2024
• Main ID: ISRCTN11469487
• Date of registration: 13/01/2015
• Prospective Registration: No
• Primary sponsor: Attikon University Hospital
• Public title: Aromatase inhibitors in girls: Anastrozole combined to the LHRH analogue leuprorelin in Girls with early or precocious puberty and a compromised growth potential
• Scientific title: The aromatase inhibitor anastrozole combined to the LHRH analogue leuprorelin vs leuprorelin alone in ameliorating predicted adult height In girls with early or precosious puberty with a compromised growth potential
• Date of first enrolment: 01/01/2008
• Target sample size: 40
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN11469487
• Study type: Interventional
• Study design: Prospective Phase IIa and IIb study, performed in two cooperating centers. (Treatment)
• Phase: Phase II

Countries of recruitment

Greece

Contacts

• Name: Dimitrios Papadimitriou

Key inclusion & exclusion criteria

Inclusion criteria: 1. Idiopathic precocious (breast development < 7.5 yrs) or early puberty (breast development 7.5-9 yrs)
2. Previously naïve to any hormonal therapy
3. PAH lower than -2 SDS or -1.5 SDS lower than their target height (mid parental height -6.5 cm)
Exclusion criteria: 1. Organic precocious puberty
2. Syndromic, systemic or hereditary conditions that either impair growth or associate with PP
3. Bone diseases related to short stature (i.e. hypochondroplasia)

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Compromised predicted adult height in girls with early or precocious puberty
Nutritional, Metabolic, Endocrine

Intervention(s)

An initial phase IIa trial with 5 girls on the combined treatment for 1 year was performed. Girls with idiopathic precocious (<7.5yrs) or early (7.5-9yrs) puberty, all with a PAH lower than -2 or more than 1.5 SDS lower than their target height (TH) are randomized on leuprorelin 0.3 mg/kg/month plus anastrozole 1 mg/day p.o. (group-A) or on leuprorelin only (group-B) for 2 yrs or until the age of 11 yrs. After completion of this initial phase, girls on the combined treatment will be randomized to anastrozole monotherapy 1 mg/day p.o. or no treatment and followed every 6 months until bone age reaches reaches 14 years or near adult height is achieved (height velocity < 2 cm/year). The girls on leuprorelin only will be followed every 6 months without any relevant hormonal treatment until bone age reaches 14 years or near adult height is achieved.

Primary Outcome(s)

1. Predicted adult height calculated according to the Bayley Pinneau tables with a bone age calculated according to the atlas of Greulich and Pyle, at 6-12-18-24 months.
2. Height velocity
3. Height for bone age
4. Bone age advancement
5. BMI

Participants are followed until bone age reaches 14 or near adult height is achieved.

Secondary Outcome(s)

1. Potential hyperandrogenism (clinical or biochemical)
2. Ovarian cyst formation (pelvic ultrasound)
3. Bone mineral density (evaluated yearly by DXA)
4. Radiological evaluation of the lumbar spine (yearly)
5. Reports of peculiar behavior

Secondary ID(s)

9804

Source(s) of Monetary Support

Investigator initiated and funded

Secondary Sponsor(s)

Athens Medical Center

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Attikon University Hospital Ethics Committee, 2008, ref: 36/2008 13/3/08.

Results

• Results available: Yes
• Date Completed: 31/12/2017