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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00573716

Enrollment

Registered

2007-12-14

Start date

2006-10-31

Completion date

2009-10-31

Last updated

2011-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychiatry

Keywords

bone mineral content, aripiprazole monotherapy, risperidone monotherapy

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.

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

11 Years to 17 Years

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results