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Arimidex in McCune Albright Syndrome

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ClinicalTrials.gov Identifier: NCT00055302
Recruitment Status : Completed
First Posted : February 26, 2003
Last Update Posted : September 1, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The primary objective of this study is to evaluate the safety and efficacy of anastrozole 1 mg given once daily in subjects with McCune-Albright Syndrome.

Condition or disease Intervention/treatment Phase
McCune-Albright Syndrome Drug: Arimidex 1 mg Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study Evaluating the Safety and Efficacy of Anastrozole™ (ARIMIDEX) in the Treatment of Precocious Puberty in Girls With McCune-Albright Syndrome
Study Start Date : August 2002
Actual Primary Completion Date : February 2006
Actual Study Completion Date : August 2015


Arm Intervention/treatment
Experimental: 1 Drug: Arimidex 1 mg
Arimidex (anastrozole) 1mg once daily by mouth



Primary Outcome Measures :
  1. The efficacy of study treatment will be assessed based on the change from baseline measurements relating to vaginal bleeding, bone age, and growth velocity [ Time Frame: 12 months or until the subject demonstrates the lack of efficacy bases upon progression of primary endpoints or experiences serious drug-related toxicity requiring withdrawal ]


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Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • informed written consent of parent/legal guardian and subject assent (as needed by local requirements)
  • females less than or equal to 10 years of age
  • diagnosed with McCune-Albright Syndrome
  • have progressive precocious puberty

Exclusion Criteria: Any one of the following is regarded as a criterion for exclusion from the study:

  • any prior treatment of MAS associated with progressive precocious puberty with a third generation aromatase inhibitor (anastrozole, letrozole, exemestane) in which no clinical response was seen
  • concomitant treatment of precocious puberty associated with MAS, with the exception of bisphosphonates for polyostotic fibrous dysplasia and LHRH analogues in the case of central precocious puberty
  • liver function tests at screening visit (AST, ALT) > or = 3x the upper limit of the reference range for age
  • known hypersensitivity to any component of study medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00055302


Locations
France
Research Site
Montpellier, France
Research Site
Paris, France
Germany
Research Site
Berlin, Germany
Research Site
Erlangen, Germany
Research Site
Osnabrück, Germany
Italy
Research Site
Torino, Italy
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Arimidex Medical Science Director, MD AstraZeneca

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00055302     History of Changes
Other Study ID Numbers: 1033IL/0046
D5394C00046
First Posted: February 26, 2003    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015

Keywords provided by AstraZeneca:
vaginal bleeding
advanced bone age
fibrous dysplasia
MAS
McCune-Albright Syndrome

Additional relevant MeSH terms:
Fibrous Dysplasia, Polyostotic
Fibrous Dysplasia of Bone
Syndrome
Disease
Pathologic Processes
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs