Clinical trial NCT00573716: Comparison of Bone Mineral Density Changes During Tx With Risperidone or Aripiprazole in Adolescents
Official title: A Comparison of Bone Mineral Density Changes During Treatment With Risperidone or Aripiprazole in Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychiatry
Keywords: bone mineral content
aripiprazole monotherapy
risperidone monotherapy
Lead sponsor: Creighton University
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2007-12-14
Enrollment: 60
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from psychiatry clinic and community resources

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.

Eligibility criteria: 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

Primary outcomes:
measure: That compared to risperidone, pediatric aripiprazole therapy is not associated with hyperprolactinemia and reduced bone mineral content and/or altered bone metabolism
timeFrame: This is a 2-visit study
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton Department of Psychiatry
state: Nebraska
Study officials:
affiliation: Creighton University
name: Sriram Ramaswamy, M.D.
role: PRINCIPAL_INVESTIGATOR
References: