Vertebral Fracture and Osteonecrosis Associated With High-dose Glucocorticoid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00679978
Recruitment Status : Completed
First Posted : May 19, 2008
Last Update Posted : September 18, 2009
Information provided by:
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.

Condition or disease
Vertebral Fracture Osteonecrosis Rheumatic Diseases

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). 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 Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vertebral Fracture and Osteonecrosis of the Femoral Head Associated With High-dose Glucocorticoid Therapy
Study Start Date : January 2001
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

A: etidronate

Primary Outcome Measures :
  1. new vertebral fracture [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. osteonecrosis of the femoral head [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to our hospital for the treatment of active systemic rheumatic diseases taking at least 0.5 mg/kg/day for PSL equivalent

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

Publications of Results:
Responsible Party: Hideto Kameda, Department of Rheumatology/Clinical Immunology, Saitama Medical Center Identifier: NCT00679978     History of Changes
Other Study ID Numbers: SaitamaVFOFH
First Posted: May 19, 2008    Key Record Dates
Last Update Posted: September 18, 2009
Last Verified: September 2009

Keywords provided by Saitama Medical University:
bone mineral density
osteonecrosis of the femoral head

Additional relevant MeSH terms:
Fractures, Bone
Rheumatic Diseases
Collagen Diseases
Spinal Fractures
Wounds and Injuries
Bone Diseases
Musculoskeletal Diseases
Pathologic Processes
Connective Tissue Diseases
Spinal Injuries
Back Injuries
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs