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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00138983
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : November 29, 2006
Dutch Health Care Insurance Board
Information provided by:
UMC Utrecht

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Polymyalgia Rheumatica Giant Cell Arteritis Polymyositis Wegener’s Granulomatosis Drug: Alendronate versus alfacalcidol (1-alpha OH vitamin D) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
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 Start Date : May 2000
Study Completion Date : November 2003

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

Secondary Outcome Measures :
  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.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00138983

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UMC Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Dutch Health Care Insurance Board
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Principal Investigator: J.W.J. Bijslma, Prof. UMC Utrecht
Study Director: R.N.J.T.L. de Nijs, MD UMC Utrecht

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00138983     History of Changes
Other Study ID Numbers: OG67-STOP-study
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: November 29, 2006
Last Verified: March 2000
Keywords provided by UMC Utrecht:
glucocorticoid-induced osteoporosis
rheumatic diseases
randomized double-blind, double placebo controlled trial
alendronate versus alfacalcidol
Additional relevant MeSH terms:
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Rheumatic Diseases
Polymyalgia Rheumatica
Granulomatosis with Polyangiitis
Giant Cell Arteritis
Collagen Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Metabolic
Bone Diseases
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Muscular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases