Rheumatoid Arthritis Clinical Trial
Official title:
Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases. The STOP-Study: a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol.
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 placebo controlled trial with alendronate versus alfacalcidol.
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 by GCs. Active vitamin D analogues like alfacalcidol directly stimulate
osteoblasts leading to an increase in bone formation. Bisphosphonates like alendronate
induce apoptosis of osteoclasts leading to inhibition of bone resorption.
We performed a randomized, double-placebo, double-blind clinical trial of 18 months duration
in patients with a rheumatic disease, starting GCs in a dosage of 7.5 mg prednisone
equivalent daily or higher. Two hundred one patients were allocated to receive either
alendronate 10 mg and alfacalcidol-placebo daily or alfacalcidol 1 microgram and
alendronate-placebo daily. Primary outcome was change in bone mineral density of the lumbar
spine in 18 months, secondary outcome incidence of (symptomatic) morphometric vertebral
deformities.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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