Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol.

NCT00138983 | Completed Phase 3

• 1 other identifier: OG67-STOP-study
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 placebo controlled trial with alendronate versus alfacalcidol.

Conditions

Rheumatoid Arthritis; Polymyalgia Rheumatica; Giant Cell Arteritis; Polymyositis; Wegener's Granulomatosis

Keywords

glucocorticoid-induced osteoporosis; rheumatic diseases; prevention; randomized double-blind, double placebo controlled trial; alendronate versus alfacalcidol

Outcome Measures

Primary Outcomes (1)

• Percent change in bone mineral density of the lumbar spine (lumbar vertebrae 2 to 4) at 18 months.

Secondary Outcomes (1)

• 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.

Interventions

Alendronate versus alfacalcidol (1-alpha OH vitamin D) DRUG

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UMC Utrecht: lead
• Dutch Health Care Insurance Board: collaborator

Study Sites (1)

UMC Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

Location

Related Publications (6)

• 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.

  PMID: 2407167 BACKGROUND

• 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.

  PMID: 15138667 BACKGROUND

• 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.

  PMID: 9682041 BACKGROUND

• 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.

  PMID: 16914703 RESULT

• 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.

  PMID: 17557758 DERIVED

• 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.

  PMID: 17407214 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Polymyalgia Rheumatica; Giant Cell Arteritis; Polymyositis; Granulomatosis with Polyangiitis; Rheumatic Diseases

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Myositis; Neuromuscular Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis

Study Officials

• J.W.J. Bijslma, Prof.

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

• R.N.J.T.L. de Nijs, MD

  UMC Utrecht

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 29, 2005
• First Posted: August 30, 2005
• Study Start: May 1, 2000
• Study Completion: November 1, 2003
• Last Updated: November 29, 2006

Record last verified: 2000-03

Locations

NL (1)