Status:
COMPLETED
Steroid Induced Osteoporosis in Patients With Systemic Lupus Erythematosus
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Systemic Lupus Erythematosus
Eligibility:
FEMALE
18-80 years
Phase:
PHASE4
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 ...
Detailed Description
In the first part of the study, 150 consecutive patients with a diagnosis of SLE were included in the study. All patients fulfilled the American College of Rheumatology (ACR) revised criteria for the ...
Eligibility Criteria
Inclusion
- Part I
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00668330
Start Date
April 1 2007
End Date
May 1 2009
Last Update
February 13 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
School of Pharmacy CUHK
Hong Kong, China