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

Information source: UMC Utrecht
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis; Polymyalgia Rheumatica; Giant Cell Arteritis; Polymyositis; Wegener’s Granulomatosis

Intervention: Alendronate versus alfacalcidol (1-alpha OH vitamin D) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: UMC Utrecht

Official(s) and/or principal investigator(s):
J.W.J. Bijslma, Prof., Principal Investigator, Affiliation: UMC Utrecht
R.N.J.T.L. de Nijs, MD, Study Director, Affiliation: UMC Utrecht


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

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

Secondary outcome: 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.

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.


Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.


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


- 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


Locations and Contacts

UMC Utrecht, Utrecht 3584 CX, Netherlands
Additional Information

Related publications:

Lukert BP, Raisz LG. Glucocorticoid-induced osteoporosis: pathogenesis and management. Ann Intern Med. 1990 Mar 1;112(5):352-64. Review.

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. Epub 2004 May 7. Review.

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.

Starting date: May 2000
Last updated: November 28, 2006

Page last updated: August 20, 2015

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