Vertebral Fracture and Osteonecrosis Associated With High-dose Glucocorticoid - Full Text View

Purpose

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	Phase
Vertebral Fracture Osteonecrosis Rheumatic Diseases	Phase 4

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Vertebral Fracture and Osteonecrosis of the Femoral Head Associated With High-dose Glucocorticoid Therapy

Resource links provided by NLM:

MedlinePlus related topics: Fractures Osteonecrosis Steroids

U.S. FDA Resources

Further study details as provided by Saitama Medical University:

Primary Outcome Measures:

new vertebral fracture [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

osteonecrosis of the femoral head [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	January 2001
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts
A A: etidronate

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
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

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided by Saitama Medical University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 rheumatic diseases. Intern Med. 2009;48(22):1931-8. Epub 2009 Nov 16.

Responsible Party:	Hideto Kameda, Department of Rheumatology/Clinical Immunology, Saitama Medical Center
ClinicalTrials.gov Identifier:	NCT00679978 History of Changes
Other Study ID Numbers:	SaitamaVFOFH, 14211301
Study First Received:	May 14, 2008
Last Updated:	September 17, 2009
Health Authority:	Japan: Institutional Review Board

Keywords provided by Saitama Medical University:

osteoporosis
glucocorticoid
bone mineral density
osteonecrosis of the femoral head

Additional relevant MeSH terms:

Fractures, Bone
Osteonecrosis
Rheumatic Diseases
Spinal Fractures
Wounds and Injuries
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes

Connective Tissue Diseases
Spinal Injuries
Back Injuries
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013