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

This study has been completed.
Bristol-Myers Squibb
Information provided by:
Creighton University Identifier:
First received: December 12, 2007
Last updated: August 3, 2011
Last verified: August 2011
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.


Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: A Comparison of Bone Mineral Density Changes During Treatment With Risperidone or Aripiprazole in Adolescents

Resource links provided by NLM:

Further study details as provided by Creighton University:

Primary Outcome Measures:
  • That compared to risperidone, pediatric aripiprazole therapy is not associated with hyperprolactinemia and reduced bone mineral content and/or altered bone metabolism [ Time Frame: This is a 2-visit study ]

Estimated Enrollment: 60
Study Start Date: October 2006
Study Completion Date: October 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
15 subjects who are taking aripiprazole monotherapy
15 subjects who are taking Risperidone therapy
30 healthy volunteers with an ethnicity, sex, and pubertal stage match of subjects taking aripiprazole monotherapy and Risperidone therapy

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.

Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited from psychiatry clinic and community resources

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
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Please refer to this study by its identifier: NCT00573716

United States, Nebraska
Creighton Department of Psychiatry
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Bristol-Myers Squibb
Principal Investigator: Sriram Ramaswamy, M.D. Creighton University
  More Information

Responsible Party: Sriram Ramaswamy, M.D., Assistant Professor of Psychiatry, Creighton University Identifier: NCT00573716     History of Changes
Other Study ID Numbers: 06-14240
Study First Received: December 12, 2007
Last Updated: August 3, 2011

Keywords provided by Creighton University:
bone mineral content
aripiprazole monotherapy
risperidone monotherapy

Additional relevant MeSH terms:
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents processed this record on September 21, 2017