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Sponsors and Collaborators: |
UMC Utrecht Dutch Health Care Insurance Board |
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Information provided by: | UMC Utrecht |
ClinicalTrials.gov Identifier: | NCT00138983 |
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.
Condition | Intervention | Phase |
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Rheumatoid Arthritis Polymyalgia Rheumatica Giant Cell Arteritis Polymyositis Wegener’s Granulomatosis |
Drug: Alendronate versus alfacalcidol (1-alpha OH vitamin D) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases. The STOP-Study: a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol. |
Estimated Enrollment: | 200 |
Study Start Date: | May 2000 |
Estimated Study Completion Date: | November 2003 |
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.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
UMC Utrecht | |
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 |
Study ID Numbers: | OG67-STOP-study |
Study First Received: | August 29, 2005 |
Last Updated: | November 28, 2006 |
ClinicalTrials.gov Identifier: | NCT00138983 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
glucocorticoid-induced osteoporosis rheumatic diseases prevention randomized double-blind, double placebo controlled trial alendronate versus alfacalcidol |
Temporal arteritis 1-hydroxycholecalciferol Wegener's granulomatosis Arthritis, Rheumatoid Brain Diseases Bone Diseases Cerebrovascular Disorders Myositis Neuromuscular Diseases Urologic Diseases Respiratory Tract Diseases Musculoskeletal Diseases Alendronate Arthritis Polymyositis |
Connective Tissue Diseases Idiopathic myopathy Kidney Diseases Arteritis Autoimmune Diseases of the Nervous System Lung Diseases, Interstitial Vasculitis Autoimmune Diseases Skin Diseases Joint Diseases Ergocalciferols Vascular Diseases Osteoporosis Central Nervous System Diseases Bone Diseases, Metabolic |
Skin Diseases, Vascular Immune System Diseases Growth Substances Vitamins Physiological Effects of Drugs Nervous System Diseases |
Bone Density Conservation Agents Cardiovascular Diseases Micronutrients Vasculitis, Central Nervous System Pharmacologic Actions |