Vertebral Fracture and Osteonecrosis Associated With High-dose Glucocorticoid

Rheumatic Diseases Clinical Trial

Official title:

Vertebral Fracture and Osteonecrosis of the Femoral Head Associated With High-dose Glucocorticoid Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00679978
• Other study ID #: SaitamaVFOFH
• Secondary ID: 14211301
• Status: Completed
• Phase: Phase 4
• First received: May 14, 2008
• Last updated: September 17, 2009
• Start date: January 2001
• Est. completion date: October 2007

Study information

• Verified date: September 2009
• Source: Saitama Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• Fractures, Bone
• Osteonecrosis
• Rheumatic Diseases
• Spinal Fractures
• Vertebral Fracture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Saitama Medical University

References & Publications (1)

Kameda H, Amano K, Nagasawa H, Ogawa H, Sekiguchi N, Takei H, Suzuki K, Takeuchi T. Notable difference between the development of vertebral fracture and osteonecrosis of the femoral head in patients treated with high-dose glucocorticoids for systemic rheu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	new vertebral fracture		2 years
Secondary	osteonecrosis of the femoral head		2 years