Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol.
|ClinicalTrials.gov Identifier: NCT00138983|
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : November 29, 2006
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis Polymyalgia Rheumatica Giant Cell Arteritis Polymyositis Wegener’s Granulomatosis||Drug: Alendronate versus alfacalcidol (1-alpha OH vitamin D)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases. The STOP-Study: a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol.|
|Study Start Date :||May 2000|
|Estimated Study Completion Date :||November 2003|
- Percent change in bone mineral density of the lumbar spine (lumbar vertebrae 2 to 4) at 18 months.
- Percent change in bone mineral density of the femoral neck and total hip at 18 months and incidence of morphometrical vertebral deformities, symptomatic vertebral fractures and non-vertebral fractures.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00138983
|Utrecht, Netherlands, 3584 CX|
|Principal Investigator:||J.W.J. Bijslma, Prof.||UMC Utrecht|
|Study Director:||R.N.J.T.L. de Nijs, MD||UMC Utrecht|