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

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ClinicalTrials.gov Identifier: NCT00138983
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : November 29, 2006
Sponsor:
Collaborator:
Dutch Health Care Insurance Board
Information provided by:
UMC Utrecht

Tracking Information
First Submitted Date  ICMJE August 29, 2005
First Posted Date  ICMJE August 30, 2005
Last Update Posted Date November 29, 2006
Study Start Date  ICMJE May 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2005)
Percent change in bone mineral density of the lumbar spine (lumbar vertebrae 2 to 4) at 18 months.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00138983 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2005)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol.
Official Title  ICMJE Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases. The STOP-Study: a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol.
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.
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.

Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Rheumatoid Arthritis
  • Polymyalgia Rheumatica
  • Giant Cell Arteritis
  • Polymyositis
  • Wegener’s Granulomatosis
Intervention  ICMJE Drug: Alendronate versus alfacalcidol (1-alpha OH vitamin D)
Study Arms Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 29, 2005)
200
Original Enrollment  ICMJE Same as current
Study Completion Date November 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00138983
Other Study ID Numbers  ICMJE OG67-STOP-study
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE UMC Utrecht
Collaborators  ICMJE Dutch Health Care Insurance Board
Investigators  ICMJE
Principal Investigator: J.W.J. Bijslma, Prof. UMC Utrecht
Study Director: R.N.J.T.L. de Nijs, MD UMC Utrecht
PRS Account UMC Utrecht
Verification Date March 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP