Clinical Trials Directory

Trials / Completed

CompletedNCT00573716

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
Phase
Study type
Observational
Enrollment
60 (estimated)
Sponsor
Creighton University · Academic / Other
Sex
All
Age
11 Years – 17 Years
Healthy volunteers
Accepted

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.

Conditions

Timeline

Start date
2006-10-01
Primary completion
2009-06-01
Completion
2009-10-01
First posted
2007-12-14
Last updated
2011-08-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00573716. Inclusion in this directory is not an endorsement.