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

Psychiatry Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00573716
• Other study ID #: 06-14240
• Status: Completed
• Phase: N/A
• First received: December 12, 2007
• Last updated: August 3, 2011
• Start date: October 2006
• Est. completion date: October 2009

Study information

• Verified date: August 2011
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 17 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Psychiatry

Locations

Country	Name	City	State
United States	Creighton Department of Psychiatry	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Creighton University	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No