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Comparison of Bone Mineral Density Changes During Tx With Risperidone or Aripiprazole in Adolescents

Sponsor
Creighton University (Other)
Overall Status
Completed
CT.gov ID
NCT00573716
Collaborator
Bristol-Myers Squibb (Industry)
60
Enrollment
1
Location
36
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study examines if the use of antipsychotic medications might contribute to an interruption in bone mineral development and/or a reduction in bone mineral content in adolescents.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Studies have shown that some antipsychotic medications, including Risperdal, can increase prolactin levels in both adult and pediatric populations. Prolactin is a hormone made by the central nervous system. The main function of prolactin is to regulate lactation in females. However, having too much prolactin over time can interrupt bone mineral accrual and a decrease in bone density. Since peak bone mass is reached during adolescents, this is a key determinant of a lifetime risk of osteoporosis. On the other hand, there ahve been no reports of increased prolactin using Abilify. In fact, in adults Abilify has been shown to normalize or even lower prolactin levels. In this study, we will compare the amount of prolactin and bone mineral density of adolescents who take Risperdal or Abilify with bone mineral density of adolescents who do nto take antipsychotic medications. We will also compare the amount of prolactin and bone mineral density of adolescents who take Risperdal with those who take Abilify. This study will also help us to learn about the relationship between medications, prolactin levels, sex steroids, and bone formation markers in adolescents.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    A Comparison of Bone Mineral Density Changes During Treatment With Risperidone or Aripiprazole in Adolescents
    Study Start Date :
    Oct 1, 2006
    Actual Primary Completion Date :
    Jun 1, 2009
    Actual Study Completion Date :
    Oct 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    1

    15 subjects who are taking aripiprazole monotherapy
    2

    15 subjects who are taking Risperidone therapy
    3

    30 healthy volunteers with an ethnicity, sex, and pubertal stage match of subjects taking aripiprazole monotherapy and Risperidone therapy

    Outcome Measures

    Primary Outcome Measures

    1. That compared to risperidone, pediatric aripiprazole therapy is not associated with hyperprolactinemia and reduced bone mineral content and/or altered bone metabolism [This is a 2-visit study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    11 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Between the ages of 11 and 17 years

    • Females and males on aripiprazole or risperidone monotherapy for minimum one year

    • Within 10th and 90th percentile for height and weight

    Exclusion Criteria:

    • Pregnancy

    • Chronic illness such as asthma, inflammatory bowel disease, rheumatoid disorders or cystic fibrosis, on chronic systemic steroid therapy for past 12 months

    • Menstrual irregularities secondary to excessive physical activity

    • History of anorexia nervosa and/or bulimia nervosa

    • Subjects on hormonal contraception

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Creighton Department of Psychiatry Omaha Nebraska United States 68131

    Sponsors and Collaborators

    • Creighton University
    • Bristol-Myers Squibb

    Investigators

    • Principal Investigator: Sriram Ramaswamy, M.D., Creighton University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00573716
    Other Study ID Numbers:
    • 06-14240
    First Posted:
    Dec 14, 2007
    Last Update Posted:
    Aug 4, 2011
    Last Verified:
    Aug 1, 2011
    Keywords provided by , ,
    bone mineral content
    aripiprazole monotherapy
    risperidone monotherapy

    Study Results

    No Results Posted as of Aug 4, 2011