drugset / Trial / NCT00668330

Steroid Induced Osteoporosis in Patients With Systemic Lupus Erythematosus

NCT00668330

Phase 4 Completed 40 enrolled Chinese University of Hong Kong
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary aim of the present study was to investigate the prevalence of low bone mineral density (BMD) and vertebral fractures, as determined by a standardized assessment, and to elucidate the role of bone qualities, including micro-architecture, bone remodeling, bone turnover, mineralization and inflammation on bone density and prevalent vertebral fractures in a large population of systemic lupus erythematosus (SLE) patients. The secondary aim of the study is to evaluate the following parameters in women with steroid induced OP (SIOP) before and after 1 year of treatment using: 1. The changes in BMD using dual energy X-ray absorptiometry (DXA) 2. Bone mineralization and architecture in-vivo using a newly available high-resolution human micro-computed tomography (ExtremCT), which can provide us with new insights into how the degree and distribution of mineralization are affected by long-term oral Ibandronate treatment. 3. Changes in perfusion and marrow edema before and after treatment of Ibandronate using dynamic Magnetic Resonance Imaging (MRI) in these patients with SIOP. 4. The investigators prospectively evaluate the correlation between the changes in brachial arterial endothelial function and lumbar spine BMD in female lupus patients over the period of 1 year.

Timeline

Start
2007-04
Primary completion
2009-05
Completion
2009-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Alfacalcidol Other / unclassified 1 ug
Comparator Ibandronate Other / unclassified 150 mg
Comparator Calcium carbonate Other / unclassified 500 mg