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Completed

NCT Number: NCT00679978

Vertebral Fracture and Osteonecrosis Associated With High-dose Glucocorticoid

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.

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Key information

Conditions

Vertebral Fracture Back Injuries Bone Diseases Bone Diseases, Metabolic Connective Tissue Diseases Femur Head Necrosis Fractures, Bone Legg-Calve-Perthes Disease Metabolic Diseases Musculoskeletal Diseases Necrosis Nutritional and Metabolic Diseases Osteonecrosis Osteoporosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Skin and Connective Tissue Diseases Spinal Fractures Spinal Injuries Wounds and Injuries

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. new vertebral fracture

    Time frame: 2 years

Secondary outcomes

  1. osteonecrosis of the femoral head

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Saitama Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
May 19, 2008
Registry last updated
Sep 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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