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

Sponsored by:	Saitama Medical University
Information provided by:	Saitama Medical University
ClinicalTrials.gov Identifier:	NCT00679978

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). We 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 IV

MedlinePlus related topics: Fractures Osteonecrosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Vertebral Fracture and Osteonecrosis of the Femoral Head Associated With High-Dose Glucocorticoid Therapy

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

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

Responsible Party:	Department of Rheumatology/Clinical Immunology, Saitama Medical Center ( Hideto Kameda )
Study ID Numbers:	SaitamaVFOFH, 14211301
Study First Received:	May 14, 2008
Last Updated:	May 15, 2008
ClinicalTrials.gov Identifier:	NCT00679978
Health Authority:	Japan: Institutional Review Board

Keywords provided by Saitama Medical University:

osteoporosis
glucocorticoid
bone mineral density
osteonecrosis of the femoral head

Study placed in the following topic categories:

Osteonecrosis
Fractures, Bone
Spinal Fractures
Wounds and Injuries
Osteoporosis
Disorders of Environmental Origin
Rheumatic Diseases

Bone Diseases
Necrosis
Musculoskeletal Diseases
Spinal Injuries
Connective Tissue Diseases
Back Injuries

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009