NCT00679978

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2001

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2008

Completed
Last Updated

September 18, 2009

Status Verified

September 1, 2009

Enrollment Period

6.8 years

First QC Date

May 14, 2008

Last Update Submit

September 17, 2009

Conditions

Vertebral FractureOsteonecrosisRheumatic Diseases

Keywords

osteoporosisglucocorticoidbone mineral densityosteonecrosis of the femoral head

Outcome Measures

Primary Outcomes (1)

  • new vertebral fracture

    2 years

Secondary Outcomes (1)

  • osteonecrosis of the femoral head

    2 years

Study Arms (1)

A

A: etidronate

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • Patients who were not appropriate for this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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 rheumatic diseases. Intern Med. 2009;48(22):1931-8. doi: 10.2169/internalmedicine.48.2414. Epub 2009 Nov 16.

    PMID: 19915292RESULT

MeSH Terms

Conditions

Spinal FracturesOsteonecrosisRheumatic DiseasesOsteoporosisLegg-Calve-Perthes Disease

Condition Hierarchy (Ancestors)

Spinal InjuriesBack InjuriesWounds and InjuriesFractures, BoneBone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsConnective Tissue DiseasesSkin and Connective Tissue DiseasesBone Diseases, MetabolicMetabolic DiseasesNutritional and Metabolic DiseasesFemur Head Necrosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 14, 2008

First Posted

May 19, 2008

Study Start

January 1, 2001

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

September 18, 2009

Record last verified: 2009-09