Status:
COMPLETED
Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol.
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Dutch Health Care Insurance Board
Conditions:
Rheumatoid Arthritis
Polymyalgia Rheumatica
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine wich treatment is the most effective in prevention of glucocorticoid-induced osteoporosis in patients with rheumatic diseases. The STOP-study: a randomized pl...
Detailed Description
Treatment with glucocorticoids (GCs) is associated with bone loss initiated already early in therapy, causing increased (vertebral) fracture risk. Bone loss is caused by inhibition of bone formation b...
Eligibility Criteria
Inclusion
- Patients with a rheumatic disease.
- Starting treatment with glucocorticoids in a dosage of 7.5 mg prednisone equivalent daily or higher.
- All ethnic groups and races.
Exclusion
- Glucocorticoid treatment in the past 12 months (except for 12 weeks preceding the study)
- Primary hyperparathyroidism, hyperthyroidism or hypothyroidism in last year
- Metabolic bone disease
- Creatinine clearance of \< 50 ml/min
- Documented hypercalcemia or hypercalciuria, nephrolithiasis in the last 5 years
- Pregnancy or lactation
- Treatment in the last 12 months with hormone-replacement therapy
- Anabolic steroids, calcitonin, active vitamin D3 analogues, fluoride or bisphosphonates.
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
End Date :
November 1 2003
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00138983
Start Date
May 1 2000
End Date
November 1 2003
Last Update
November 29 2006
Active Locations (1)
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1
UMC Utrecht
Utrecht, Utrecht, Netherlands, 3584 CX