Bone Mineral Content and Bone Metabolism in Adolescents on Antipsychotic Therapy (NCT00399776) | Clinical Trial Compass
CompletedNot Applicable
Bone Mineral Content and Bone Metabolism in Adolescents on Antipsychotic Therapy
United States60 participantsStarted 2006-10
Plain-language 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. 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. 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.
Who can participate
Age range
10 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 -
Exclusion criteria
. Pregnant
. Chronic illness such as asthma, inflammatory bowel disease, rheumatoid disorders or cystic fibrosis.
. On chronic systemic steroid therapy for the past 12 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Antipsychotic induced hyperprolactinemia can decrease bone mineral accrual