- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00138983
Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol.
Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases. The STOP-Study: a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol.
Study Overview
Status
Conditions
Intervention / Treatment
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 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
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Utrecht, Netherlands, 3584 CX
- UMC Utrecht
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Percent change in bone mineral density of the lumbar spine (lumbar vertebrae 2 to 4) at 18 months.
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Secondary Outcome Measures
Outcome Measure |
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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.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: J.W.J. Bijslma, Prof., UMC Utrecht
- Study Director: R.N.J.T.L. de Nijs, MD, UMC Utrecht
Publications and helpful links
General Publications
- Saag KG, Emkey R, Schnitzer TJ, Brown JP, Hawkins F, Goemaere S, Thamsborg G, Liberman UA, Delmas PD, Malice MP, Czachur M, Daifotis AG. Alendronate for the prevention and treatment of glucocorticoid-induced osteoporosis. Glucocorticoid-Induced Osteoporosis Intervention Study Group. N Engl J Med. 1998 Jul 30;339(5):292-9. doi: 10.1056/NEJM199807303390502.
- Lukert BP, Raisz LG. Glucocorticoid-induced osteoporosis: pathogenesis and management. Ann Intern Med. 1990 Mar 1;112(5):352-64. doi: 10.7326/0003-4819-112-5-352.
- de Nijs RN, Jacobs JW, Algra A, Lems WF, Bijlsma JW. Prevention and treatment of glucocorticoid-induced osteoporosis with active vitamin D3 analogues: a review with meta-analysis of randomized controlled trials including organ transplantation studies. Osteoporos Int. 2004 Aug;15(8):589-602. doi: 10.1007/s00198-004-1614-5. Epub 2004 May 7.
- de Nijs RN, Jacobs JW, Lems WF, Laan RF, Algra A, Huisman AM, Buskens E, de Laet CE, Oostveen AC, Geusens PP, Bruyn GA, Dijkmans BA, Bijlsma JW; STOP Investigators. Alendronate or alfacalcidol in glucocorticoid-induced osteoporosis. N Engl J Med. 2006 Aug 17;355(7):675-84. doi: 10.1056/NEJMoa053569.
- de Nijs RN, Jacobs JW, Lems WF, Laan RF, Algra A, Huisman AM, Buskens E, de Laet CE, Oostveen JC, Geusens PP, Bruyn GA, Dijkmans BA, Bijlsmat JW. [Alendronate more effective than alfacalcidol in the prevention of osteoporosis in patients with rheumatic disease who are starting glucocorticoid therapy]. Ned Tijdschr Geneeskd. 2007 May 26;151(21):1178-85. Dutch.
- Jacobs JW, de Nijs RN, Lems WF, Geusens PP, Laan RF, Huisman AM, Algra A, Buskens E, Hofbauer LC, Oostveen AC, Bruyn GA, Dijkmans BA, Bijlsma JW. Prevention of glucocorticoid induced osteoporosis with alendronate or alfacalcidol: relations of change in bone mineral density, bone markers, and calcium homeostasis. J Rheumatol. 2007 May;34(5):1051-7. Epub 2007 Apr 1.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Skin Diseases
- Respiratory Tract Diseases
- Immune System Diseases
- Autoimmune Diseases of the Nervous System
- Autoimmune Diseases
- Lung Diseases
- Musculoskeletal Diseases
- Connective Tissue Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Vasculitis
- Skin Diseases, Vascular
- Bone Diseases
- Lung Diseases, Interstitial
- Bone Diseases, Metabolic
- Myositis
- Vasculitis, Central Nervous System
- Systemic Vasculitis
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Rheumatic Diseases
- Collagen Diseases
- Osteoporosis
- Polymyalgia Rheumatica
- Giant Cell Arteritis
- Arteritis
- Granulomatosis with Polyangiitis
- Polymyositis
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Vitamin D
- Alendronate
- Alfacalcidol
- Hydroxycholecalciferols
Other Study ID Numbers
- OG67-STOP-study
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