Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022841
Status:
TERMINATED
Last Update Posted:
2007-12-19
First Post:
2001-08-14
Brief Title:
Prevention of Steroid-Induced Osteoporosis in Children
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Study Overview
Official Title:
Prevention of Steroid-Induced Osteoporosis in Children
Status:
TERMINATED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inadequate eligible subjects to expect sufficient numbers to analyse outcomes
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether the drug pamidronate can safely and effectively improve bone mineral density in growing children who have bone disease caused by taking steroid medications People who take steroid medications called glucocorticoids like prednisone or dexamethasone for long periods almost always have decreased bone density and are at increased risk of breaking a bone Research has shown that pamidronate improves bone density in adults who take glucocorticoids However use of pamidronate is not approved in children because it has not been extensively tested in children It is possible that children will have a different response or unique problems with the medication because their bones are still growing We will assign all study participants to one of two groups One group will receive pamidronate intravenously through a vein every 3 months in addition of daily oral calcium and vitamin D and the other group will receive calcium and vitamin D The study is scheduled to run for 36 months with visits to the study center once every 3 months
Detailed Description:
This is a randomized study to determine whether pamidronate can safely and effectively improve bone mineral density BMD in children with glucocorticoid-induced osteoporosis After we stratify participants on the basis of whether they are taking glucocorticoids for treatment of inflammatory disease or for immunosuppression following organ transplant we will randomize them to receive daily calcium and vitamin D in addition to 30 mgkg 1 mgkg for weight less then 30 kg of pamidronate in normal saline every 3 months or daily calcium and vitamin D only for 24 months followed by a 12-month followup period off of therapy We will measure endpoints at 24 months The primary endpoint is lumbar spine BMD determined by DEXA Secondary endpoints will include volumetric BMD of the spine proximal femur BMD and volumetric BMD total body bone mineral content BMC fracture incidence bone turnover markers and growth and skeletal changes The study radiologist will be blinded to treatment group
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-065 | None | None | None |