Steroid Induced Osteoporosis in Patients With Systemic Lupus Erythematosus

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Alfacalcidol; Calcium; Calcium, Dietary; Diphosphonates; Hydroxycholecalciferols; Ibandronic Acid

Criteria

Part I

Inclusion Criteria:

• Fulfilled the ACR revised criteria for the classification of SLE

• Provided written informed consent for their participation

Part II

Inclusion Criteria:

• Have low BMD (T socre < -1 S.D. at the lumbar spine (L1-L4) or total hip) induced by the long-term administration of high-dose corticosteroids.

• Had been receiving chronic uninterrupted corticosteroid therapy for at least 1 year or had received a corticosteroid dose of at least 5 mg/day.

Exclusion Criteria:

• Hypocalcaemia, hypercalcaemia, Hypercalciuria, a creatinine clearance of less than 30 ml per minute.

• A history of nephrolithiasis during the previous five years.

• A history of recent major gastrointestinal (GI) tract disease (e.g. oesophagitis).

• Had or presence of primary hyperparathyroidism, hyperthyroidism, or hypothyroidism in the year before the study began.

• Had experienced any previous adverse reaction to bisphosphonate therapy (alendronate, fosamax, ibandronate).

• With uncontrolled active or recurrent peptic ulcer disease.

• Receiving therapy (within the last 6 months) known to affect bone metabolism, including:hormone-replacement agents, calcitonin, active vitamin D3 analogues, thiazide diuretics,treatment with bisphosphonates,fluoride treatment within the last 12 mons or for a total duration of 2 years; contraindications to calcium or vitamin D therapy.

• Pregnant or breastfeeding.