Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008762
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2001-01-16
Brief Title:
Bone Health of People With Cystic Fibrosis
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
Bone Health of People With Cystic Fibrosis
Status:
COMPLETED
Status Verified Date:
2003-12
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:
People with cystic fibrosis CF now frequently live into adulthood and with this extended life expectancy has come new clinical problems Poor bone health including osteoporosis and bone fractures is one of these increasingly important conditions Preventing the negative outcomes of poor bone health in later life is primarily related to ensuring optimal growth weight and height and obtaining maximal amount of bone mass during growth and development This study will identify factors that influence bone health in a sample of children adolescents and young adults as measured by dual energy x-ray absorptiometry and new bone densitometry methods peripheral quantitative computerized tomography p-QCT and bone sonometer We will also identify factors which influence changes in bone status over a 12-month follow-up period in a subsample of people with CF
Detailed Description:
A total of 100 subjects with CF and pancreatic insufficiency 8-25 y half female will be recruited from the Childrens Hospital of Philadelphia CHOP and the Delaware Valley region All subjects will have baseline measurements obtained at the Nutrition and Growth Lab at CHOP A subset of subjects will return for 12-month follow-up measurements
We will evaluate the influences on bone health including gender stage of pubertal development body weight and height food intake especially calcium and vitamin D use of steroid medications by mouth IV administration or inhalation physical activity and lung health We will also follow the changes in bone health and growth over 12 months and see what factors are associated with good and poor bone development
In addition the information from this study will be very important to planning the future trials of medication and other interventions to treat and hopefully to prevent poor bone health in people with CF
We will evaluate the influences on bone health including gender stage of pubertal development body weight and height food intake especially calcium and vitamin D use of steroid medications by mouth IV administration or inhalation physical activity and lung health We will also follow the changes in bone health and growth over 12 months and see what factors are associated with good and poor bone development
In addition the information from this study will be very important to planning the future trials of medication and other interventions to treat and hopefully to prevent poor bone health in people with CF
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: