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Steroid Induced Osteoporosis in Patients With Systemic Lupus Erythematosus

NCT00668330 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-02-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ibandronate+alfacalcidol+calcium

Ibandronate 150 mg monthly plus daily alfacalcidol (1ug)500mg plus calcium

DRUG

placebo ibandronate+alfacalcidol+calcium

placebo ibandronate monthly plus daily alfacalcidol(1ug)500mg calcium

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Edmund K Li, MD · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00668330 on ClinicalTrials.gov