Steroid Induced Osteoporosis in Patients With Systemic Lupus Erythematosus
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2007
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 25, 2008
CompletedFirst Posted
Study publicly available on registry
April 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFebruary 13, 2012
February 1, 2012
2.1 years
April 25, 2008
February 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Evaluation of the changes in bone mineralization and architecture measured by Xtreme CT.
baseline, month 6 and month 12
Evaluation of the changes in perfusion and marrow edema using MRI.
baseline, month 6, month 12
Study Arms (2)
Ibandronate+alfacalcidol+calcium
ACTIVE COMPARATORBonviva
Placebo ibandronate+alfacalcidol+calcium
ACTIVE COMPARATORInterventions
Ibandronate 150 mg monthly plus daily alfacalcidol (1ug)500mg plus calcium
placebo ibandronate monthly plus daily alfacalcidol(1ug)500mg calcium
Eligibility Criteria
You may qualify if:
- Fulfilled the ACR revised criteria for the classification of SLE
- Provided written informed consent for their participation
- Part II
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Pharmacy CUHK
Hong Kong, China
Related Publications (1)
Li EK, Zhu TY, Hung VY, Kwok AW, Lee VW, Lee KK, Griffith JF, Li M, Wong KC, Leung PC, Qin L, Tam LS. Ibandronate increases cortical bone density in patients with systemic lupus erythematosus on long-term glucocorticoid. Arthritis Res Ther. 2010;12(5):R198. doi: 10.1186/ar3170. Epub 2010 Oct 22.
PMID: 20964867DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edmund K Li, MD
Chinese University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 25, 2008
First Posted
April 29, 2008
Study Start
April 1, 2007
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
February 13, 2012
Record last verified: 2012-02