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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00138983
First Posted: August 30, 2005
Last Update Posted: November 29, 2006
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.
Collaborator:
Dutch Health Care Insurance Board
Information provided by:
UMC Utrecht
  Purpose
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 Intervention Phase
Rheumatoid Arthritis Polymyalgia Rheumatica Giant Cell Arteritis Polymyositis Wegener’s Granulomatosis Drug: Alendronate versus alfacalcidol (1-alpha OH vitamin D) Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 200
Study Start Date: May 2000
Estimated Study Completion Date: November 2003
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.

  Eligibility

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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00138983


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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00138983     History of Changes
Other Study ID Numbers: OG67-STOP-study
First Submitted: August 29, 2005
First Posted: August 30, 2005
Last Update Posted: November 29, 2006
Last Verified: March 2000

Keywords provided by UMC Utrecht:
glucocorticoid-induced osteoporosis
rheumatic diseases
prevention
randomized double-blind, double placebo controlled trial
alendronate versus alfacalcidol

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Osteoporosis
Rheumatic Diseases
Arteritis
Collagen Diseases
Granulomatosis with Polyangiitis
Giant Cell Arteritis
Polymyalgia Rheumatica
Polymyositis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Metabolic
Bone Diseases
Metabolic Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Systemic Vasculitis
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders