Effects of Hyperprolactinemia Induced by Antipsychotic Drugs on Bone Metabolism
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Bone turnover biochemical markers
研究概览
简要总结
The study is aimed to assess the severities of hyperprolactinemia caused by antipsychotic drugs and the effects of the duration of hyperprolactinemia on bone metabolism in schizophrenia patients.
详细描述
Hyperprolactinemia is a common adverse effect of antipsychotic drugs. Studies have shown that hyperprolactinemia may affect bone metabolism through direct and indirect effects and increase the risk of osteoporosis and fracture.The investigators assess the duration, the severity of hyperprolactinemia and its effects on bone metabolism in schizophrenics taking antipsychotic drugs through analyzing the correlation between prolactin levels and biochemical markers of bone metabolism and the correlation between the duration of hyperprolactinemia and abnormal bone metabolism. Meanwhile, the investigators aims to obtain the boundary value of prolactin levels in patients with abnormal bone metabolism.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of the disease meets the ICD-10 diagnostic criteria for schizophrenia
- •Subjects Intend to use atypical antipsychotics
- •Age between 18 and 50 years of age
排除标准
- •Pregnant and breast feeding women
- •Abnormal lipid metabolism
- •The level of serum alanine aminotransferase or aspartate aminotransferase is two times higher than the upper limit of the normal
- •Patients with diabetes or impaired fasting glucose
- •The level of prolactin is higher than normal
- •Patients taking drugs that affect bone metabolism (e.g. selective serotonin reuptake inhibitors antidepressants, antiepileptic drugs)
- •The level of creatinine is 1.2 times higher than the upper limit of the normal value
结局指标
主要结局
Bone turnover biochemical markers
时间窗: baseline ,4 weeks ,8 weeks，12 weeks and 26 weeks
changes in the level of serum bone alkaline phosphatase ,serum β-crosslaps and from baseline to 4, 8, 12 and 26 weeks after enrollment
次要结局
- serum prolactin(baseline ,4 weeks ,8 weeks，12 weeks and 26 weeks)