Ignite Creation Date:
2024-05-05 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 9:49 AM
Study NCT ID:
NCT00679978
Status:
COMPLETED
Last Update Posted:
2009-09-18
First Post:
2008-05-14
Brief Title:
Vertebral Fracture and Osteonecrosis Associated With High-dose Glucocorticoid
Sponsor:
Saitama Medical University
Organization:
Saitama Medical University
Study Overview
Official Title:
Vertebral Fracture and Osteonecrosis of the Femoral Head Associated With High-dose Glucocorticoid Therapy
Status:
COMPLETED
Status Verified Date:
2009-09
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:
Osteoporotic vertebral fracture VF and osteonecrosis of the femoral head OFH are major concerns in patients with systemic rheumatic diseases treated with high-dose glucocorticoids GCs The investigators examined and compared the incidence and risk factors of VF with those of OFH in patients who had recently received high-dose GC therapy to clarify the relationship between these two complications
Detailed Description:
Patients with rheumatic diseases receiving GCs 05 mgkgday for prednisolone equivalent within the past 2 months were enrolled in this study and treated with 200 mgday of etidronate cyclically The bone mineral density BMD of lumbar spines L2-4 was examined by QDR2000 OFH was evaluated by magnetic resonance imaging MRI ClinicalTrialsgov identifier NCT00679978
Forty-four patients completed the 2-year study including annual X-rays and the BMD analysis MRI evaluation at entry and 2 years was performed in 41 patients The BMD values with anteroposterior AP and lateral views decreased by 64 and 97 respectively in the first year but were stable in the second year Eleven patients developed VF and 9 patients developed OFH The risk factors for VF included previous VF and a low BMD value T score -15 of AP view at baseline with odds ratio OR 149 95CI 29-764 while the risk factor for OFH was the recent maximum GC dosage 12 mgkgday versus OR77 95CI 13-455 and the decrease in BMD value of lateral view 15 versus OR67 95 CI 12-361 in the first year
Forty-four patients completed the 2-year study including annual X-rays and the BMD analysis MRI evaluation at entry and 2 years was performed in 41 patients The BMD values with anteroposterior AP and lateral views decreased by 64 and 97 respectively in the first year but were stable in the second year Eleven patients developed VF and 9 patients developed OFH The risk factors for VF included previous VF and a low BMD value T score -15 of AP view at baseline with odds ratio OR 149 95CI 29-764 while the risk factor for OFH was the recent maximum GC dosage 12 mgkgday versus OR77 95CI 13-455 and the decrease in BMD value of lateral view 15 versus OR67 95 CI 12-361 in the first year
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 |
|---|---|---|---|
| 14211301 | None | None | None |