Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399776
Status:
COMPLETED
Last Update Posted:
2011-08-04
First Post:
2006-11-13
Brief Title:
Bone Mineral Content and Bone Metabolism in Adolescents on Antipsychotic Therapy
Sponsor:
Creighton University
Organization:
Creighton University
Study Overview
Official Title:
Bone Mineral Content and Bone Metabolism in Adolescents on Antipsychotic Therapy
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Detailed Description:
Recent studies have shown an increase in antipsychotic prescriptions among children and adolescents Virtually all pediatric use of antipsychotics is off-label meaning without a Food and Drug Administration indication To make matters worse pediatric antipsychotic usage can lead to serious side effects like movement disorders and metabolic disturbances Hence it is concerning that despite the virtual absence of long term efficacy and safety data the widespread use of antipsychotics in children and adolescents continues One important adverse effects of antipsychotic therapy is hyperprolactinemia Prolactin is a hormone secreted by the central nervous system The main action of prolactin in females is the induction and maintenance of lactation The main action of prolactin in females is the induction and maintenance of lactation Antipsychotic therapy has shown to raise prolactin levels both in the adult and pediatric population Sustained hyperprolactinemia can cause a number of endocrinological abnormalities leading to a hypogonadal state and eventually bone demineralization and osteoporosis There is evidence linking pediatric prolactinomas to decreased bone density Also adult studies suggest that the high rates of osteoporosis in schizophrenia may result from hypogonadism secondary to antipsychotic induced hyperprolactinemia Our concern is that the sequela of antipsychotic induced hyperprolactinemia in children and adolescents has received little attention despite the important implications for bone health This topic is especially important because peak bone mass is achieved during adolescence and is a key determinant of the lifetime risk of osteoporosis
We hypothesize that antipsychotic induced hyperprolactinemia can interrupt bone mineral accrual and reduce bone mineral content in adolescents on antipsychotic therapy We plan to measure bone mineral content and peripheral markers of bone metabolism in adolescents on antipsychotic therapy and compare them with ethnicity gender and pubertal stage matched controls We also plan to measure serum levels of prolactin and other hormonal measures such as estradiol progesterone testosterone follicle stimulating hormone luteinizing hormone and thyroid function tests in both the groups Statistical analysis will be performed to compare bone mineral content between the study and control groups Additionally the association between the hormonal measures and bone mineral content will be determined
Osteoporosis is a major public health problem In the United States today 10 million individuals already have osteoporosis and 18 million more have low bone mass placing them at an increased risk for this disorder Optimization of bone health is a process that must occur throughout the lifespan and factors that influence bone health at all ages are essential to prevent osteoporosis and its devastating consequences To date there are no published studies examining the association between antipsychotic induced hyperprolactinemia and bone mineral content BMC andor risk of osteoporosis in children or adolescents Although there have been reports of antipsychotic induced hyperprolactinemia in both prepubertal and postpubertal children it has been suggested that post pubertal children may be at a higher risk of decreased BMC Thus we plan to initially study the effects on adolescents Potential implications of our research findings include providing recommendations for preventing diagnosing and monitoring bone mineral contentdensity during pediatric antipsychotic therapy Since this is an unexplored area yet very crucial field findings from our study can be expected to have ramifications for clinical practice within one to two years of project completion
We hypothesize that antipsychotic induced hyperprolactinemia can interrupt bone mineral accrual and reduce bone mineral content in adolescents on antipsychotic therapy We plan to measure bone mineral content and peripheral markers of bone metabolism in adolescents on antipsychotic therapy and compare them with ethnicity gender and pubertal stage matched controls We also plan to measure serum levels of prolactin and other hormonal measures such as estradiol progesterone testosterone follicle stimulating hormone luteinizing hormone and thyroid function tests in both the groups Statistical analysis will be performed to compare bone mineral content between the study and control groups Additionally the association between the hormonal measures and bone mineral content will be determined
Osteoporosis is a major public health problem In the United States today 10 million individuals already have osteoporosis and 18 million more have low bone mass placing them at an increased risk for this disorder Optimization of bone health is a process that must occur throughout the lifespan and factors that influence bone health at all ages are essential to prevent osteoporosis and its devastating consequences To date there are no published studies examining the association between antipsychotic induced hyperprolactinemia and bone mineral content BMC andor risk of osteoporosis in children or adolescents Although there have been reports of antipsychotic induced hyperprolactinemia in both prepubertal and postpubertal children it has been suggested that post pubertal children may be at a higher risk of decreased BMC Thus we plan to initially study the effects on adolescents Potential implications of our research findings include providing recommendations for preventing diagnosing and monitoring bone mineral contentdensity during pediatric antipsychotic therapy Since this is an unexplored area yet very crucial field findings from our study can be expected to have ramifications for clinical practice within one to two years of project completion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None