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Steroid Induced Osteoporosis in Patients With Systemic Lupus Erythematosus-Prevalence,Risk Factors and Treatment
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.
Details
| Lead sponsor | Chinese University of Hong Kong |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 40 |
| Start date | 2007-04 |
| Completion | 2009-05 |
Conditions
- Systemic Lupus Erythematosus
Interventions
- Ibandronate+alfacalcidol+calcium
- placebo ibandronate+alfacalcidol+calcium
Primary outcomes
- The primary outcome of Part I study is to investigate the prevalence of low BMD and vertebral fractures. Primary outcome of part II study is the improvement of bone mineral density measured by DEXA. — baseline and month 12
Countries
China