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

NCT ID: NCT00138983

Last Updated: 2006-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Study Completion Date

2003-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Alendronate versus alfacalcidol (1-alpha OH vitamin D)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dutch Health Care Insurance Board

OTHER

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Principal Investigators

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J.W.J. Bijslma, Prof.

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

R.N.J.T.L. de Nijs, MD

Role: STUDY_DIRECTOR

UMC Utrecht

Locations

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UMC Utrecht

Utrecht, Utrecht, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 2407167 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15138667 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9682041 (View on PubMed)

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.

Reference Type RESULT
PMID: 16914703 (View on PubMed)

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.

Reference Type DERIVED
PMID: 17557758 (View on PubMed)

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.

Reference Type DERIVED
PMID: 17407214 (View on PubMed)

Other Identifiers

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OG67-STOP-study

Identifier Type: -

Identifier Source: org_study_id