Vertebral Fracture and Osteonecrosis Associated With High-dose Glucocorticoid

Completed

• Conditions: Vertebral Fracture; Rheumatic Diseases; Osteonecrosis

• Registration Number: NCT00679978
• Lead Sponsor: Saitama Medical University

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 (≧0.5 mg/kg/day for prednisolone equivalent) within the past 2 months were enrolled in this study, and treated with 200 mg/day 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). ClinicalTrials.gov 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 6.4% and 9.7% 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 \< -1.5) of AP view at baseline with odds ratio (OR) 14.9 (95%CI 2.9-76.4), while the risk factor for OFH was the recent maximum GC dosage (\>1.2 mg/kg/day versus ≦; OR=7.7, 95%CI 1.3-45.5) and the decrease in BMD value of lateral view (\>15% versus ≤; OR=6.7, 95% CI 1.2-36.1) in the first year.

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Study First Submitted: 2008-05-14
• Study First Submitted QC: 2008-05-15
• Study First Posted: 2008-05-19
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-17
• Last Update Posted: 2009-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients admitted to our hospital for the treatment of active systemic rheumatic diseases taking at least 0.5 mg/kg/day for PSL equivalent between January 2001 and June 2003 were eligible for this prospective study

Exclusion Criteria

• Patients who were not appropriate for this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
new vertebral fracture	2 years

Secondary Outcome Measures

Name	Time	Method
osteonecrosis of the femoral head	2 years