CompletedPhase 4

Steroid Induced Osteoporosis in Patients With Systemic Lupus Erythematosus

China40 participantsStarted 2007-04

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: baseline and month 12

Trial details

NCT IDNCT00668330

SponsorChinese University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-05

View on ClinicalTrials.gov More Systemic Lupus Erythematosus trials