Bone Mineral Content and Bone Metabolism in Adolescents on Antipsychotic Therapy

NCT00399776 | Completed

• 1 other identifier: 06-14216
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

We hypothesize that antipsychotic induced hyperprolactinemia can decrease bone mineral accrual and decrease bone mineral content (BMC) in adolescents on antipsychotic therapy. Specifics Aims

1. 1.To determine if antipsychotic therapy leads to decreased bone mineral accrual and decreased bone mineral content in a group of adolescents on antipsychotic therapy by comparing them to an ethnicity, gender and pubertal stage matched control group.
2. 2.To determine the relationship between serum concentrations of prolactin, sex steroids and bone turnover markers in adolescents on antipsychotic therapy and an ethnicity, gender and pubertal stage matched control group.

Conditions

Adolescent Depression

Keywords

bone mineral; antipsychotic therapy; bone mineral accrual; bone mineral content

Outcome Measures

Primary Outcomes (1)

• Antipsychotic induced hyperprolactinemia can decrease bone mineral accrual

  This is a 2 visit study

Secondary Outcomes (1)

• Determine relationship between serum concentrations of prolactin, sex steroids and bone turnover markers in adolescents on antipsychotic therapy

  This is a 2 visit study

Study Arms (2)

Group A

Adolescents taking haloperidol, risperidone, or olanzapine

Radiation: Bone Density Test

Group B

Healthy adolescents

Radiation: Bone Density Test

Interventions

Bone Density Test RADIATION

Evaluating bone mineral content and bone metabolism in adolescents on antipsychotic therapy compared to healthy adolescents

Group A; Group B

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from within the clinic as well as community psychiatrists

You may qualify if:

• Adolescent females and males with antipsychotic exposure equivalent to at least 100 chlorpromazine equivalents for a minimum of one year.
• Age between 10 and 17 years of age
• Within 10th and 90th percentile for height and weight -

You may not qualify if:

• Pregnant
• Chronic illness such as asthma, inflammatory bowel disease, rheumatoid disorders or cystic fibrosis.
• On chronic systemic steroid therapy for the past 12 months
• For subjects with hypothyroidism and on thyroid replacement therapy, TSH level will be obtained to determine eligibility.
• Menstrual irregularities secondary to excessive physical activity.
• History of anorexia nervosa and/or bulimia nervosa.
• Subjects on hormonal contraception. -

Sponsors & Collaborators

• Creighton University: lead
• Thrasher Research Fund: collaborator

Study Sites (1)

Creighton University Psychiatry Research Center

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Interventions

Bone Density

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sriram Ramaswamy, M.D.

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 13, 2006
• First Posted: November 15, 2006
• Study Start: October 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: August 4, 2011

Record last verified: 2011-08

Locations

US (1)